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REGENXBIO Inc.

$13.28

+0.19 (+1.45%)

C 45Pipeline Score Fair Value Biotech · Commercial
Market Cap
328.28 M
EPS
-5.59
P/E Ratio
-
Value Trade
8.53 M
SEC Financials
Q1 2026
  • Dilution Risk

    80%
  • Revenue

    6.39 M

  • R&D Expenses

    57.34 M

  • Operating CF

    -76.19 M


  • Total Assets

    341.89 M

  • Total Liabilities

    320.81 M

  • Equity

    21.08 M

  • D/E Ratio

    12,345

1.6 %
Week
-31.57 %
1 Month
-23.49 %
3 Month
-41.58 %
6 Month
-82.29 %
5 Year
-79.02 %
All Time
Cash Data
Distressed
  • Cash Position

    150.49 M

  • Monthly Burn

    25.39 M

  • Runway

    4.2 mo

  • Burn Trend

    Accelerating
  • SEC Filing

    May 14, 2026
Overview
Volume
3.30 M
52 Week Range
5.46 - 16.19
% held by Insiders
9.58 %
% held by Institutions
81.2 %
Enterprise Value
426.18 M
Total Shares
51.62 M
Short %
23.96 %
Float Shares
38.66 M
Company Description
HQ: 9804 MEDICAL CENTER DRIVE, ROC...
Employees:371

locked

Upcoming Catalyst
Catalyst Drug/Treatment Stage Probability of Approval Description Drug Type Therapeutic Area Source
Phase 2

Subscribe to access the data.

Gene Therapies
Ophthalmologic System
Phase 2

Subscribe to access the data.

Gene Therapies
Ophthalmologic System
Phase 2

Subscribe to access the data.

Gene Therapies
Ophthalmologic System
Unlock Upcoming Catalyst data

Catalyst Timeline

Dated clinical, regulatory & corporate events for REGENXBIO Inc.

1032Total events
16Upcoming
224Tier-1 (high impact)
2015 – 2027Coverage

Upcoming catalysts 16

Q4 2026
T1Topline Readout
Topline data from ATMOSPHERE pivotal trial of sura-vec using subretinal delivery expected
surabgene lomparvovecwet AMDPhase III
2027
T2Runway Guidance Update
Cash runway guidance: funds operations into early 2027
2027
T1NDA Submission
Potential BLA submission for RGX-202
RGX-202Duchenne muscular dystrophy
2027
T1NDA Submission
Global regulatory submissions expected in 2027 for sura-vec subretinal wet AMD
surabgene lomparvovecwet age-related macular degeneration
2027
T2Product Launch
Expected launch in 2027
RGX-202Duchenne muscular dystrophy
Apr 30, 2027
T2Milestone Payment
$50M milestone funding upon achievement of ZOLGENSMA sales milestones
ZolgensmaApprovedSpinal Muscular Atrophy
TBD
T3Enrollment Update
Enrollment ongoing in confirmatory trial; majority expected enrolled by BLA submission
RGX-202Duchenne muscular dystrophyConfirmatory
TBD
T1Accelerated Approval Pathway
Accelerated approval pathway for RGX-202
RGX-202Duchenne muscular dystrophy
2027-H2
T1FDA Approval
Potential FDA approval
RGX-202Duchenne muscular dystrophy
TBD
T2Type A Meeting
Plans to request Type A meeting to discuss CRL and BLA resubmission
RGX-121ApprovedMucopolysaccharidosis II (MPS II)BLA
TBD
T1NDA Submission
Planned BLA resubmission after Type A meeting
RGX-121ApprovedMucopolysaccharidosis II (MPS II)BLA
2026-H1
T2First Patient Dosed
First patient dosed in Phase IIb/III DR trial expected 1H 2026
surabgene lomparvovecdiabetic retinopathyPhase IIb/III
TBD
T2Oral Presentation
Updated Phase II ALTITUDE results to be presented at a future medical meeting
surabgene lomparvovecnon-proliferative diabetic retinopathyPhase II
2026-H1
T2Milestone Payment
$100 million milestone payment from AbbVie upon first patient dosed
surabgene lomparvovecdiabetic retinopathy
TBD
T2Trial Initiation
Phase IIb/III trial to be initiated for suprachoroidal delivery in diabetic retinopathy
sura-vecdiabetic retinopathyPhase IIb/III
TBD
T2First Patient Dosed
First subject dosed in Phase III ACHIEVE trial triggers additional $100M milestone
sura-vecwet AMDPhase III

Event history 1016

Jul 2026
Oral Presentationsurabgene lomparvovecPresentation
Five-year long-term follow-up data from Phase I/IIa study of subretinal sura-vec for wet AMD to be presented at ASRS
wet AMDsource ↗
Jul 2026
Type A MeetingNAVSUNLIFDA Meeting
Type A meeting with FDA to review longer-term biomarker and clinical data
Mucopolysaccharidosis II (MPS II, Hunter syndrome)source ↗
Q3 2026
BLA SubmissionNAVSUNLIRegulatory Filing
BLA resubmission for accelerated approval
Mucopolysaccharidosis II (MPS II, Hunter syndrome)source ↗
Q3 2026
BLA SubmissionRGX-202Regulatory Filing
BLA submission under accelerated approval pathway
Duchenne muscular dystrophysource ↗
Jun 29, 2026
First Patient Dosedsurabgene lomparvovecTrial
First patient dosed in Phase IIb/III NAAVIGATE trial of surabgene lomparvovec in diabetic retinopathy
diabetic retinopathysource ↗
Jun 29, 2026
Milestone Paymentsurabgene lomparvovecCorporate
$100 million milestone payment from AbbVie for first patient dosed in NAAVIGATE trial
diabetic retinopathysource ↗
Jun 24, 2026
Enrollment CompleteRGX-202Trial
Completed dosing in confirmatory study of RGX-202
Duchenne muscular dystrophysource ↗
Jun 24, 2026
Topline ReadoutRGX-202Clinical Data
Topline pivotal dataset: primary endpoint met
Duchenne muscular dystrophysource ↗
Jun 24, 2026
Primary Endpoint MetRGX-202Clinical Data
Primary endpoint met in pivotal study
Duchenne muscular dystrophysource ↗
Jun 22, 2026
FDA Feedback ReceivedNAVSUNLIFDA Meeting
FDA alignment on path forward for BLA resubmission via accelerated approval
Mucopolysaccharidosis II (MPS II, Hunter syndrome)source ↗
Jun 22, 2026
Accelerated Approval PathwayNAVSUNLIDesignation
FDA agreed to consider accelerated approval pathway for NAVSUNLI
Mucopolysaccharidosis II (MPS II, Hunter syndrome)source ↗
Jun 2026
BLA SubmissionRGX-202Regulatory Filing
BLA submission for RGX-202 expected in mid-2026
Duchenne muscular dystrophysource ↗
Drug Pipeline Intelligence
C45
Pipeline Score
$293M
Pipeline Value
Fair Value
Valuation Signal
5
Drugs Scored
0.9x
rNPV / MCap
Top 66%
Micro Cap
(rank 309 of 906)
Percentile Rank
REGENXBIO Inc. carries a moderate pipeline score (45/100), with $2.1B risk-adjusted pipeline value, led by RGX-121-3102 in MPS II (Phase 3), but cash runway is a concern.
Showing 1 of 1 assets
DrugIndicationPhaseNCT IDPTRSrNPVStatusEnrollmentVelocityDesignCompletionML SignalLast Change
RGX-121-3102
Gene therapy
MPS IIPhase 3NCT0723660690% $570M ACTIVE NOT_RECRUITING 2 STALLED D (23) May 30, 2031 -
Jun 4, 2026
Unlock Drug Pipeline Intelligence
Clinical Trial Results
Drug Name Indications Phase Date Trial Results Summary Title Source
RGX-202
Duchenne muscular dystrophy
Phase 3
2026-05-14

93% of patients achieved RGX-202 microdystrophin expression above 10% (p<0.0001); n=30 at Week 12; interim safety (n=31); interim functional data (n=9 at 12 months)

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REGENXBIO Reports First Quarter 2026 Financial Results and Operational Highlights &#x2022; Company announced positive topline results from pivotal Phase III AFFINITY DUCHENNE study of RGX-202 o Primary endpoint achieved

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RGX-202
Duchenne muscular dystrophy
Phase 3
2026-05-14

93% of patients achieved RGX-202 microdystrophin expression above 10% (p<0.0001); n=30 at Week 12; interim safety (n=31); interim functional data (n=9 at 12 months)

Read More

REGENXBIO Reports First Quarter 2026 Financial Results and Operational Highlights &#x2022; Company announced positive topline results from pivotal Phase III AFFINITY DUCHENNE study of RGX-202 o Primary endpoint achieved

Read More
RGX-202
Duchenne muscular dystrophy
Phase 3
2026-05-14

93% of patients achieved RGX-202 microdystrophin expression above 10% (p<0.0001); n=30 at Week 12; interim safety (n=31); interim functional data (n=9 at 12 months)

Read More

REGENXBIO Reports First Quarter 2026 Financial Results and Operational Highlights &#x2022; Company announced positive topline results from pivotal Phase III AFFINITY DUCHENNE study of RGX-202 o Primary endpoint achieved

Read More
Unlock Clinical Trial Results data
Inside Trades
TREND
CORPORATE INSIDERS BOUGHT SHARES WORTH 1.8M IN THE LAST 3 MONTHS
YEARLY INSIDER TRANSACTIONS
Sector Avg.
INSIDERS
SOLD
INSIDERS
BOUGHT
POSITIVE SENTIMENT Based on 22 Insiders Transactions
Unlock Inside Trades data
Hedge Funds
TREND
HEDGE FUNDS INCREASED HOLDINGS BY 200.0K SHARES IN THE LAST QUARTER
Shares Held
2040.00B1530.00B1020.00B510.00B0
Q3
2024
Q4
2024
Q1
2025
Q2
2025
HEDGE FUNDS
SOLD
HEDGE FUNDS
BOUGHT
POSITIVE SENTIMENT Based on 27 hedge funds in the last quarter
18 buying (3 new)·9 selling (1 exited)·2 unchanged
Fund Count
60%
Share Volume
25%
Conviction
15%
HedgeFund Name
( 3 )
% of Portfolio Current MV
-
Shares Owned
-
Activity
Avg Price $0

Example Capital Management

2.5 %
15.00 M
250.00 K

Example Capital Management

2.5 %
15.00 M
250.00 K

Example Capital Management

2.5 %
15.00 M
250.00 K
Unlock Hedge Funds table data
RGNX Institutional Ownership Trends
Current Insider %
5.20%
+0.00%
Current Institutional %
62.40%
+0.00%
Total Ownership
67.60%
Insider + Institutional
Data Points
1
1 Ticker(s)
Option Chain Statistics
ExpirationVolumeOpen InterestImplied Volatility CallsImplied Volatility Puts
CallsPutsPut-Call RatioCallsPutsPut-Call RatioIVOiWaIvVWaIvIVOiWaIvVWaIv
2027-01-15 0.00 0 - - - - - -
2027-01-15 0.00 0 - - - - - -
2027-01-15 0.00 0 - - - - - -
Unlock Option Chain Statistics data
Option Chain
CallsStrikePuts
Last PriceVolumeOpen InterestLast PriceVolumeOpen Interest
No data available
Unlock Option Chain data
Unlock Options Chart data
Open interest
0 600K 1.2M 1.8M Avg OI 1.00 M Open Interest
0 1 2 3 1.1 Put-Call Ratio
Today's Open Interest
1.00 M
Put-Call Ratio
1.1
Put Open Interest
480.00 K
Call Open Interest
520.00 K
Open Interest Avg (30-day)
900,000
Today vs Open Interest Avg (30-day)
11.11%
Option Volume
0 450K 900K 1.4M Avg OV 750.00 K Option Volume
0 1 2 3 0.95 Put-Call Ratio
Today's Volume
750.00 K
Put-Call Ratio
0.95
Put Volume
360.00 K
Call Volume
390.00 K
Volume Avg (30-day)
800,000
Today vs Volume Avg (30-day)
-6.25%
Company News
RGNX
Jun 29, 2026
RGNXPhases

REGENXBIO Announces First Patient Dosed in Phase IIb/III NAAVIGATE Trial of Surabgene Lomparvovec in Diabetic Retinopathy; Company to Receive $100 Million Milestone

REGENXBIO has announced the dosing of the first patient in its Phase IIb/III NAAVIGATE trial for surabgene lomparvovec, a gene therapy for diabetic retinopathy. The company will receive a $100 million milestone payment from AbbVie. This trial aims to evaluate the safety and efficacy of sura-vec, which has shown promising results in previous studies.

Read more →
RGNX
Jun 24, 2026
RGNXFDA Updates

REGENXBIO Completes Dosing in Confirmatory Study of RGX-202, Marking Completion of Registrational Development Program and Supporting Planned BLA Submission in Q3 2026

REGENXBIO has successfully completed dosing in the confirmatory study of RGX-202, a gene therapy for Duchenne muscular dystrophy, ahead of schedule. This positions the company to submit a Biologics License Application (BLA) in Q3 2026, aiming for FDA approval by late 2027. The study demonstrated strong efficacy and safety, aligning with accelerated approval criteria.

Read more →
RGNX
Jun 22, 2026
RGNXFDA Updates

REGENXBIO Announces Alignment with FDA on Path Forward for NAVSUNLI™ BLA Resubmission for Accelerated Approval; First Potential Gene Therapy for MPS II

REGENXBIO has aligned with the FDA on the next steps for the accelerated approval of NAVSUNLI, a gene therapy for MPS II. The FDA confirmed that no additional studies are needed and will review existing data on an expedited basis. The company plans to resubmit the Biologics License Application in Q3 2026 after a Type A meeting with the FDA.

Read more →
RGNX
May 18, 2026
RGNXConferences/Events

REGENXBIO to Participate in Upcoming Investor Conferences

REGENXBIO Inc. has announced its participation in two upcoming investor conferences, highlighting its continued engagement with the investment community. The events include the RBC Capital Markets Global Healthcare Conference and the Stifel Virtual Ophthalmology Forum. REGENXBIO aims to showcase its advancements in gene therapy, particularly its late-stage treatments for rare and retinal diseases. The company has been a pioneer in AAV gene therapy since its inception in 2009.

Read more →
RGNX
May 14, 2026
RGNXPhases

REGENXBIO Announces Positive Topline Results from Pivotal Phase III AFFINITY DUCHENNE® Study of RGX-202

REGENXBIO has announced positive topline results from the Phase III AFFINITY DUCHENNE trial for RGX-202, showing that 93% of participants achieved significant microdystrophin expression. The data also indicate a strong correlation between this expression and functional improvement over a year. The therapy is reported to have a favorable safety profile, with no serious long-term adverse effects documented. As a result of these findings, REGENXBIO is preparing for potential accelerated approval in 2027.

Read more →
RGNX
May 14, 2026
RGNXPhases

REGENXBIO Reports First Quarter 2026 Financial Results and Operational Highlights &#x2022; Company announced positive topline results from pivotal Phase III AFFINITY DUCHENNE study of RGX-202 o Primary endpoint achieved

REGENXBIO Inc. reported positive topline results from its pivotal Phase III AFFINITY DUCHENNE study of RGX-202, achieving its primary endpoint with high statistical significance. The results demonstrated a significant correlation between microdystrophin expression and functional improvement in patients. Additionally, the clinical hold on RGX-121 has been lifted, indicating progress in developing treatments for Hunter syndrome. Financial results showed a substantial net loss for the first quarter of 2026, reflecting challenges in revenue generation amidst ongoing operational efforts.

Read more →
RGNX
May 7, 2026
RGNXConferences/Events

REGENXBIO Announces Presentations at the American Society of Gene &amp; Cell Therapy 2026 Annual Meeting

REGENXBIO Inc. announced its participation in the 2026 American Society of Gene & Cell Therapy Annual Meeting, featuring oral and poster presentations. Key topics include advancements in gene therapy production and pivotal data from RGX-202 for Duchenne muscular dystrophy. The event emphasizes the company's leadership in gene therapy innovation.

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RGNX
May 6, 2026
RGNXConferences/Events

REGENXBIO to Host Webcast on May 14 to Discuss Topline Results from Pivotal Trial of RGX-202 for Duchenne Muscular Dystrophy

REGENXBIO Inc. will host a webcast on May 14, 2026, to discuss topline results from its pivotal trial of RGX-202, a gene therapy for Duchenne muscular dystrophy. The webcast will feature expert physicians and will also include a report on the company's first quarter 2026 financial results. An archived version of the webcast will be available for 30 days post-event.

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RGNX
Apr 12, 2026
RGNXGeneral

REGENXBIO DEADLINE: ROSEN, A LEADING AND RANKED FIRM, Encourages REGENXBIO, Inc. Investors with Losses in Excess of $100K to Secure Counsel Before Important April 14 Deadline in Securities Class Action - RGNX

Rosen Law Firm is reminding REGENXBIO, Inc. investors of an important April 14, 2026 deadline to secure counsel for a securities class action. The lawsuit alleges that the defendants provided false and misleading information regarding the developmental status of RGX-111, a gene therapy for Hurler syndrome. Investors are encouraged to join the class action if they purchased securities during the specified class period. The case raises serious concerns about the company's transparency and the veracity of its positive trial outcomes.

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RGNX
Mar 11, 2026
RGNXPhases

REGENXBIO REPORTS NEW POSITIVE INTERIM DATA FROM PHASE I/II AFFINITY DUCHENNE® TRIAL OF RGX-202

REGENXBIO Inc. reported positive interim data from its Phase I/II AFFINITY DUCHENNE trial of RGX-202, a gene therapy for Duchenne muscular dystrophy. The data indicated significant functional improvements and cardiac health stability over one year for participants. Additionally, the trial showed no serious adverse events and a favorable safety profile, further supporting RGX-202 as a potential treatment option. Topline pivotal data is anticipated in early Q2 2026.

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RGNX
Mar 6, 2026
RGNXGeneral

REGENXBIO Inc. Sued for Securities Law Violations – Investors Should Contact The Gross Law Firm Before April 14, 2026 to Discuss Your Rights – RGNX

REGENXBIO Inc. is facing a class action lawsuit for securities law violations concerning the development of RGX-111, a gene therapy for Hurler syndrome. Allegations include the dissemination of misleading statements regarding the safety and efficacy of the therapy, coupled with the concealment of adverse data. Following the announcement of a clinical hold by the FDA due to a CNS tumor found in a trial participant, REGENXBIO's stock price plummeted by nearly 18%. Shareholders are encouraged to register for potential recovery by a specified deadline.

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RGNX
Mar 5, 2026
RGNXGeneral

REGENXBIO Reports Fourth Quarter and Full Year 2025 Financial Results and Operational Highlights

REGENXBIO Inc. reported its financial results for Q4 and the full year 2025, highlighting advancements in its gene therapy pipeline targeting rare diseases. The company noted a revenue increase driven by collaborations, despite a net loss that widened year-over-year. REGENXBIO maintains a robust cash position, projecting operational funding into early 2027.

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RGNX
Mar 4, 2026
RGNXConferences/Events

REGENXBIO Announces Presentations at the 2026 Muscular Dystrophy Association (MDA) Clinical & Scientific Conference

REGENXBIO Inc. announced its participation in the 2026 Muscular Dystrophy Association Clinical & Scientific Conference, where it will present data on its RGX-202 gene therapy for Duchenne muscular dystrophy. The presentations will cover safety, biomarker, and functional data from preclinical and Phase I/II trials. Additionally, REGENXBIO will host a symposium on advancing gene therapy trials.

Read more →
RGNX
Feb 25, 2026
RGNXConferences/Events

REGENXBIO to Host Conference Call on March 5 to Discuss Fourth Quarter and Full Year 2025 Financial Results and Operational Highlights

REGENXBIO Inc. will hold a conference call on March 5, 2026, to discuss its financial results for Q4 and the full year of 2025. The call will cover operational highlights and is set to begin at 8:00 a.m. ET. Participants are encouraged to join early and can access a replay afterward.

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RGNX
Feb 18, 2026
RGNXGeneral

REGENXBIO CLASS ACTION ALERT: Bragar Eagel & Squire, P.C. Announces that a Class Action Lawsuit Has Been Filed Against REGENXBIO Inc. and Encourages Investors to Contact the Firm

Bragar Eagel & Squire, P.C. has announced a class action lawsuit against REGENXBIO Inc., representing investors who acquired its securities between February 9, 2022, and January 27, 2026. The lawsuit arose after the company disclosed that the FDA placed a clinical hold on its gene therapy RGX-111 due to the discovery of a CNS tumor in a study participant. Following this announcement, REGENXBIO's stock price dropped significantly, reflecting investor concerns about the company's safety disclosures and overall viability.

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RGNX
Feb 9, 2026
RGNXFDA Updates

REGENXBIO Announces Regulatory Update on RGX-121 BLA for MPS II

REGENXBIO announced that the FDA issued a Complete Response Letter for its RGX-121 BLA for MPS II, citing concerns about study eligibility and data sufficiency. The company plans to discuss the CRL and potential resubmission strategies. This setback is particularly disheartening for families affected by the disease, which has no current effective treatments.

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RGNX
Jan 28, 2026
RGNXFDA Updates

REGENXBIO Announces Regulatory Update on Ultra Rare MPS Programs

REGENXBIO announced that the FDA has placed clinical holds on its gene therapies RGX-111 and RGX-121 due to safety concerns following a neoplasm case in a participant treated with RGX-111. The hold affects RGX-121 as well, despite its positive safety profile in previous patients. The company is awaiting further details from the FDA regarding the holds.

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RGNX
Jan 11, 2026
RGNXPhases

REGENXBIO Highlights Key 2026 Catalysts and Announces Positive Long-Term Functional Outcomes in Lead Duchenne Gene Therapy Program

REGENXBIO Inc. recently highlighted significant advancements in its pipeline, particularly in gene therapies for rare diseases. Notably, the RGX-202 trial demonstrated positive long-term functional outcomes for Duchenne Muscular Dystrophy patients at the pivotal dose after 18 months. The company expects to submit a Biologics License Application in mid-2026, alongside several pivotal data readouts. Furthermore, REGENXBIO is positioning itself for commercial readiness, emphasizing its in-house manufacturing capabilities and strategic partnerships.

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RGNX
Dec 18, 2025
RGNXConferences/Events

REGENXBIO to Present at the 44th Annual J.P. Morgan Healthcare Conference

REGENXBIO Inc. will present at the 44th Annual J.P. Morgan Healthcare Conference on January 14, 2026, at 10:30 a.m. PT in San Francisco. The live presentation can be accessed via their website, with an archived replay available for 30 days. REGENXBIO focuses on the curative potential of gene therapy, advancing a late-stage pipeline for various rare diseases. The event highlights the company's commitment to improving healthcare through innovative treatments.

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RGNX
Nov 25, 2025
RGNXConferences/Events

REGENXBIO to Participate in Upcoming Investor Conference

REGENXBIO Inc. will participate in the Piper Sandler 37th Annual Healthcare Conference on December 2, 2025. The event will feature a fireside chat at 8:30 a.m. ET in New York, NY. Investors can access a live webcast on the company's website, with an archived replay available for 30 days post-event. REGENXBIO focuses on gene therapy for rare and retinal diseases.

Read more →
RGNX
Nov 6, 2025
RGNXGeneral

REGENXBIO Reports Third Quarter 2025 Financial Results and Operational Highlights

REGENXBIO Inc. reported its Q3 2025 financial results, highlighting significant clinical milestones across its gene therapy programs. The company has a strong cash position of $302 million, expected to fund operations into early 2027. Despite a net loss of $61.9 million, REGENXBIO remains optimistic about its potential to deliver transformative therapies for diseases such as Duchenne muscular dystrophy and wet AMD.

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RGNX
Oct 30, 2025
RGNXPhases

REGENXBIO Announces Completion of Pivotal Enrollment and Initiates Commercial Production in Duchenne Gene Therapy Program

REGENXBIO has completed enrollment in the pivotal AFFINITY DUCHENNE trial for RGX-202, a gene therapy aimed at treating Duchenne muscular dystrophy. The company has also initiated commercial production of RGX-202, with plans for a potential launch in 2027. Positive early trial results show promising safety and efficacy, supporting the therapy's advancement.

Read more →
RGNX
Oct 29, 2025
RGNXConferences/Events

REGENXBIO to Host Conference Call on November 6 to Discuss Third Quarter 2025 Financial Results and Operational Highlights

REGENXBIO Inc. has announced a conference call scheduled for November 6, 2025, to discuss its third-quarter financial results and operational highlights. The call will begin at 8:00 a.m. ET, with a registration link provided for listeners. The company is known for its pioneering work in AAV gene therapy and has a promising pipeline of treatments for various diseases.

Read more →
RGNX
Oct 9, 2025
RGNXPhases

REGENXBIO Announces Presentation at the American Academy of Ophthalmology 2025 Annual Meeting

REGENXBIO Inc. announced it will present interim data from the Phase II ALTITUDE trial at the American Academy of Ophthalmology 2025 Annual Meeting. The trial evaluates the suprachoroidal delivery of surabgene lomparvovec (ABBV-RGX-314) for diabetic retinopathy. This investigational gene therapy aims to provide a one-time treatment for chronic retinal conditions.

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RGNX
Oct 6, 2025
RGNXPhases

REGENXBIO Announces Completion of Enrollment in Pivotal Trials of Subretinal Surabgene Lomparvovec for Wet AMD

REGENXBIO has completed enrollment in its pivotal ATMOSPHERE and ASCENT trials for surabgene lomparvovec, a potential gene therapy for wet AMD. The studies aim to evaluate the efficacy of sura-vec compared to existing treatments. Topline data is expected in Q4 2026, with promising safety and durability results noted from earlier trials.

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RGNX
Sep 29, 2025
RGNXConferences/Events

REGENXBIO Announces Presentation at the World Muscle Society

REGENXBIO Inc. announced that its Chief Medical Officer, Steve Pakola, M.D., will present new analysis of RGX-202 at the World Muscle Society Congress in Vienna. The presentation will cover 12-month functional data from the Phase I/II trial, showing RGX-202's favorable safety profile and potential as a leading gene therapy for Duchenne muscular dystrophy. The therapy exceeded baseline controls in functional measures.

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RGNX
Sep 5, 2025
RGNXPhases

REGENXBIO Presents Positive Twelve-Month Pivotal Data from Phase I/II/III CAMPSIITE® Trial of RGX-121 for Treatment of MPS II

REGENXBIO announced positive twelve-month data from the Phase I/II/III CAMPSIITE trial for RGX-121, a treatment for MPS II. The trial showed an 82% median reduction in cerebrospinal fluid levels of a key biomarker and positive neurodevelopmental outcomes. The FDA is reviewing the Biologics License Application, with a decision expected by February 2026.

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RGNX
Aug 18, 2025
RGNXFDA Updates

REGENXBIO Announces FDA Review Extension of BLA for RGX-121 to Treat Patients with MPS II - RGX-121 would be the first and only potential one-time commercially-available therapy designed to directly address the underlyin

REGENXBIO announced an extension of the FDA review timeline for its Biologics License Application (BLA) for RGX-121, moving the PDUFA goal date from November 9, 2025, to February 8, 2026. This extension occurs following the submission of additional long-term clinical data from a pivotal study. RGX-121 is posited to be a groundbreaking one-time treatment for Mucopolysaccharidosis II (MPS II), directly addressing its genetic cause. Updated clinical data will be presented at the ICIEM meeting in September 2025, continuing to indicate a positive outlook for this innovative therapy.

Read more →
RGNX
Aug 7, 2025
RGNXPhases

REGENXBIO Announces Pivotal Program for Surabgene Lomparvovec in Diabetic Retinopathy

REGENXBIO Inc. has announced the initiation of a pivotal Phase IIb/III trial for surabgene lomparvovec to treat diabetic retinopathy utilizing suprachoroidal delivery. This follows promising two-year data from the Phase II ALTITUDE trial, demonstrating safety and efficacy. Upon dosing the first subject in the trial, REGENXBIO is set to receive $100 million, with an additional $100 million for a subsequent Phase III trial. The collaboration with AbbVie will enhance support for this clinical program aimed to address the significant medical needs of diabetic retinopathy patients.

Read more →
RGNX
Aug 7, 2025
RGNXGeneral

REGENXBIO Reports Second Quarter 2025 Financial Results and Operational Highlights &#x2022; RGX-202 in Duchenne muscular dystrophy on track for topline results 1H 2026 and BLA submission mid-2026 o Pivotal trial enrollme

REGENXBIO reported strong regulatory progress for its gene therapies in the second quarter of 2025. The company indicated that RGX-202 for Duchenne muscular dystrophy is progressing well, with enrollment expected to complete by October 2025. Additionally, RGX-121 for MPS II and sura-vec for retinal diseases are advancing through pivotal trials, with anticipated results and BLA submissions in the coming years. REGENXBIO's cash position improved significantly, reflecting the successful conclusion of various partnerships and financial arrangements.

Read more →
RGNX
Jul 31, 2025
RGNXConferences/Events

REGENXBIO to Host Conference Call on August 7 to Discuss Second Quarter 2025 Financial Results and Operational Highlights

REGENXBIO Inc. has announced it will host a conference call on August 7, 2025, to discuss its financial results for the second quarter of 2025 and operational highlights. The company, known for its pioneering work in AAV gene therapy, plans to provide an update on its late-stage pipeline, which includes treatments for rare diseases. Participants can join the live call or access a replay via the company's investor website following the event.

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RGNX
Jul 10, 2025
RGNXPhases

REGENXBIO Announces Publication of Preclinical Results Demonstrating Functional Benefits of Novel Microdystrophin Construct in RGX-202 Investigational Gene Therapy for Duchenne Muscular Dystrophy

REGENXBIO announced the publication of preclinical results demonstrating the functional benefits of its investigational gene therapy RGX-202 for Duchenne Muscular Dystrophy. The microdystrophin construct, which includes a C-terminal (CT) domain, exhibited superior muscle force and resistance to damage in preclinical models compared to constructs without the CT domain. These findings support positive outcomes from the ongoing Phase I/II AFFINITY DUCHENNE trial, where RGX-202 showed promise in changing the disease trajectory for patients. REGENXBIO plans to submit a Biologics License Application in mid-2026.

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RGNX
Jun 5, 2025
RGNXPhases

REGENXBIO REPORTS NEW POSITIVE FUNCTIONAL DATA FROM PHASE I/II AFFINITY DUCHENNE® TRIAL OF RGX-202

REGENXBIO has reported positive interim data from its Phase I/II AFFINITY DUCHENNE trial for RGX-202, an investigational gene therapy for Duchenne muscular dystrophy. Participants receiving the treatment showed significant improvements in functional measures over a 12-month period, exceeding controls in areas like the North Star Ambulatory Assessment. The therapy has also demonstrated a favorable safety profile, with no serious adverse events reported. REGENXBIO plans to submit a Biologics License Application under expedited processes by mid-2026 based on these promising results.

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RGNX
Jun 2, 2025
RGNXConferences/Events

REGENXBIO to Host Webcast Discussing Interim Functional Data from the Phase I/II AFFINITY DUCHENNE® Trial of RGX-202

REGENXBIO Inc. announced a webcast to discuss interim functional data from the Phase I/II AFFINITY DUCHENNE trial for their investigational gene therapy RGX-202. This event is set to feature Dr. Aravindhan Veerapandiyan, the trial's principal investigator, and will take place on June 5, 2025. The webcast aims to share key insights into the potential therapeutic impact of RGX-202 on patients with Duchenne muscular dystrophy. REGENXBIO has a strong focus on gene therapy for rare diseases and aims to enhance healthcare delivery.

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RGNX
May 19, 2025
RGNXGeneral

REGENXBIO Announces Strategic Royalty Monetization Agreement for Up to $250 Million $150 million secured at closing extends cash runway into early 2027 REGENXBIO retains additional potential non-dilutive funding opportun

REGENXBIO Inc. has announced a strategic royalty monetization agreement with Healthcare Royalty that could provide up to $250 million. The company received an initial $150 million at the deal's closing, thus extending its cash runway until early 2027. This non-dilutive agreement will help REGENXBIO finance its late-stage clinical activities, including potential FDA approvals and key data readouts for its gene therapies. The company retains rights to future potential funding sources as well.

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RGNX
May 13, 2025
RGNXFDA Updates

REGENXBIO Announces FDA Acceptance and Priority Review of the BLA for RGX-121 for MPS II

REGENXBIO Inc. announced that the FDA has accepted its Biologics License Application for RGX-121, a gene therapy designed to treat Mucopolysaccharidosis II (MPS II). The FDA has granted Priority Review status, with a target action date of November 9, 2025. RGX-121 offers the potential to be a one-time treatment that addresses both systemic and neurodevelopmental effects of Hunter syndrome. Commercialization will be led by partner Nippon Shinyaku, while REGENXBIO will manage manufacturing and supply chain operations.

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RGNX
May 12, 2025
RGNXGeneral

REGENXBIO Reports First Quarter 2025 Financial Results and Recent Operational Highlights &#x2022; RGX-202 in Duchenne muscular dystrophy on track for BLA submission mid-2026 o Pivotal trial more than half enrolled, with

REGENXBIO reported its first quarter 2025 financial results, showing significant revenue growth driven by collaboration with Nippon Shinyaku. The company remains on track to submit a Biologics License Application for RGX-202 in mid-2026, with over half the pivotal trial enrollment already completed. Financially, REGENXBIO reported a net income of $6.1 million compared to a loss last year, indicating positive momentum. Additional pivotal trial data for other therapies is expected in the coming years.

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RGNX
May 8, 2025
RGNXConferences/Events

REGENXBIO Announces Presentations at the American Society of Gene & Cell Therapy 28th Annual Meeting

REGENXBIO Inc. announced its participation in the 28th Annual Meeting of the American Society of Gene & Cell Therapy taking place from May 13 to 17, 2025, in New Orleans. The company will present data from late-stage clinical trials for its investigational therapies RGX-121 and RGX-202, focusing on treatments for MPS II and Duchenne muscular dystrophy, respectively. The presentations will discuss advancements in manufacturing and data from clinical trials, indicating progress in their gene therapy development efforts.

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RGNX
Apr 30, 2025
RGNXConferences/Events

REGENXBIO to Host Conference Call on May 12 to Discuss First Quarter 2025 Financial Results and Recent Operational Highlights

REGENXBIO Inc. announced a conference call to be held on May 12, 2025, to discuss its financial results from Q1 2025 and recent operational highlights. The call will provide insights into the company's ongoing projects and financial performance, catering to both analysts and the public. Registration for the call and replay details are available on their investor website, emphasizing transparency and engagement with stakeholders.

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RGNX
Mar 19, 2025
RGNXPhases

REGENXBIO REPORTS POSITIVE BIOMARKER DATA FROM AFFINITY DUCHENNE® TRIAL OF RGX-202 GENE THERAPY

REGENXBIO has announced positive interim data from the Phase I/II AFFINITY DUCHENNE trial of RGX-202, a gene therapy for Duchenne muscular dystrophy. Results indicate robust microdystrophin expression at 122.3% in a 3-year-old patient, reinforcing safety and efficacy findings. The ongoing trial is progressing toward enrollment completion and a BLA submission projected for mid-2026, addressing an urgent need for treatment options in affected patients aged 1 and above. Further functional data from the trial is expected in the first half of 2025.

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RGNX
Mar 13, 2025
RGNXFDA Updates

REGENXBIO Reports Fourth Quarter and Full Year 2024 Financial Results and Recent Operational Updates &#x2022; Biologics Licensing Application (BLA) for clemidsogene lanparvovec (RGX-121) submitted and on track for potent

REGENXBIO has reported its financial results for the fourth quarter and full year 2024, highlighting significant operational updates. The company has submitted a Biologics Licensing Application for its gene therapy RGX-121, targeting potential FDA approval in the second half of 2025. Additionally, the ongoing pivotal trial for RGX-202 for Duchenne Muscular Dystrophy is progressing, with completion of enrollment expected in 2025. However, REGENXBIO faced a decline in revenue due to reduced Zolgensma royalties and reported an increased net loss compared to the prior year.

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RGNX
Mar 10, 2025
RGNXConferences/Events

REGENXBIO Announces Presentations at the 2025 Muscular Dystrophy Association (MDA) Clinical & Scientific Conference

REGENXBIO Inc. has announced that new interim biomarker data from its Phase I/II AFFINITY DUCHENNE trial of RGX-202 will be presented at the 2025 Muscular Dystrophy Association Clinical & Scientific Conference. The presentation will take place on March 19, 2025, and feature insights from leading experts in the field. Additionally, the conference will highlight the enhanced therapeutic potential of a microdystrophin with an extended C-terminal domain. This event underscores REGENXBIO's commitment to advancing gene therapies for Duchenne muscular dystrophy.

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RGNX
Mar 4, 2025
RGNXGeneral

REGENXBIO Announces Closing of Strategic Partnership with Nippon Shinyaku for MPS Diseases ROCKVILLE, Md.

REGENXBIO has successfully closed a strategic partnership with Nippon Shinyaku to develop and commercialize gene therapies RGX-121 for MPS II and RGX-111 for MPS I. RGX-121 is poised to be the first gene therapy for MPS II, with potential FDA approval by late 2025. The collaboration aims to address significant unmet needs in the MPS patient community and shows promise based on positive interim trial data for RGX-111. The partnership enables REGENXBIO to advance these transformative therapies towards commercialization effectively.

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RGNX
Feb 26, 2025
RGNXConferences/Events

REGENXBIO to Host Conference Call on March 13 to Discuss Fourth Quarter and Full Year 2024 Financial Results and Recent Operational Highlights

REGENXBIO Inc. announced a conference call scheduled for March 13 to discuss its financial results for Q4 and full-year 2024, along with recent operational highlights. The call is part of the company's commitment to keeping investors informed. The company continues to advance its pipeline of AAV Therapeutics aimed at treating rare diseases. A replay of the conference call will be available shortly after its conclusion.

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RGNX
Jan 30, 2025
RGNXConferences/Events

REGENXBIO Announces Presentations of RGX-121 at the 21st Annual WORLDSymposium 2025

REGENXBIO Inc. announced that it will present data on RGX-121, a gene therapy for mucopolysaccharidosis type II (MPS II), at the 21st Annual WORLDSymposium 2025 in San Diego. Presentations will include topline results from the pivotal phase of the CAMPSIITE trial, showcasing ongoing advancements in the treatment of this rare genetic disorder. The scheduled presentation times and the involvement of experts underline the significance of the findings in pursuing innovative treatments for MPS II.

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RGNX
Jan 14, 2025
RGNXGeneral

REGENXBIO and Nippon Shinyaku Announce Exclusive Partnership to Develop and Commercialize RGX-121 and RGX-111 for MPS Diseases REGENXBIO to receive $110 million upfront, potential milestone payments of up to $700 million

REGENXBIO and Nippon Shinyaku have formed an exclusive partnership to develop and commercialize RGX-121 and RGX-111 for treating MPS diseases. REGENXBIO will receive $110 million upfront, with potential milestone payments reaching up to $700 million. The partnership aims to leverage both companies' strengths in gene therapy, with future clinical development led by REGENXBIO. Both therapies are positioned to have a significant impact on patients and their families.

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RGNX
Nov 18, 2024
RGNXPhases

REGENXBIO INITIATES PIVOTAL PHASE OF AFFINITY DUCHENNE TRIAL OF RGX-202 GENE THERAPY AND REPORTS POSITIVE FUNCTIONAL DATA Alignment achieved with FDA on AFFINITY DUCHENNE pivotal program and access to accelerated approva

REGENXBIO has initiated the pivotal phase of its AFFINITY DUCHENNE trial for RGX-202, a gene therapy targeting Duchenne muscular dystrophy, and reported promising efficacy and safety data from earlier study phases. The trial has dosed its first patient and aims to support a Biologics License Application (BLA) submission by 2026 via the accelerated approval pathway. Positive functional outcomes were noted in participants, with significant improvements in assessment scores compared to external controls. The company is the only gene therapy sponsor recruiting patients under four years old in the U.S.

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RGNX
Nov 14, 2024
RGNXConferences/Events

REGENXBIO to Host Webcast Discussing Pivotal Program and First Functional Data from the AFFINITY DUCHENNE® Trial of RGX-202

REGENXBIO Inc. will host a webcast on November 18, 2024, to discuss the AFFINITY DUCHENNE trial and present the first functional data from its Phase I/II study of RGX-202, a gene therapy aimed at treating Duchenne muscular dystrophy. The event will feature key insights from principal investigator Aravindhan Veerapandiyan, M.D., and Michael Kelly, PhD, Chief Scientific Officer of CureDuchenne. Additionally, findings will be presented at the upcoming 2024 Breakthroughs in Muscular Dystrophy conference in Chicago.

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RGNX
Nov 6, 2024
RGNXPhases

REGENXBIO Reports Third Quarter 2024 Financial Results and Recent Operational Updates &#x2022; Advancement in Phase I/II AFFINITY DUCHENNE trial of RGX-202 for Duchenne Muscular Dystrophy; pivotal trial initiation and fi

REGENXBIO Inc. reported its financial results for Q3 2024 alongside key operational updates. The company has made significant progress in its Phase I/II AFFINITY DUCHENNE trial of RGX-202 for Duchenne Muscular Dystrophy, with the last patient dosed in the pivotal dose expansion cohort. Additionally, REGENXBIO has initiated a BLA submission for RGX-121, anticipated to be completed by Q1 2025, and positive data has emerged from trials for ABBV-RGX-314 concerning vision preservation for patients with wet AMD. However, the company reported a decrease in revenue and net loss compared to the same period last year.

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RGNX
Oct 30, 2024
RGNXConferences/Events

REGENXBIO to Host Conference Call on November 6 to Discuss Third Quarter 2024 Financial Results and Recent Operational Highlights

REGENXBIO Inc. will host a conference call on November 6 to discuss its financial results for Q3 2024 and provide updates on operational highlights. The company has been advancing its pipeline of AAV Therapeutics aimed at rare and retinal diseases. Interested participants can register for the webcast and analysts will have the opportunity to engage in a Q&A session.

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RGNX
Oct 21, 2024
RGNXPhases

REGENXBIO Presents Positive Data from the Phase II Study of Subretinal ABBV-RGX-314 in Patients with Bilateral Wet AMD at AAO 2024

REGENXBIO has presented promising data from the Phase II study of ABBV-RGX-314 for treating bilateral wet age-related macular degeneration (AMD) at the AAO 2024 meeting. The results show a remarkable 97% reduction in treatment burden nine months after administration, with 100% of patients needing either zero or only one supplemental injection. The treatment was well-tolerated, with no serious adverse events reported. This study highlights the potential for ABBV-RGX-314 to significantly change the management of wet AMD, a condition affecting millions worldwide.

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RGNX
Oct 18, 2024
RGNXConferences/Events

REGENXBIO Announces Presentations at the American Academy of Ophthalmology 2024 Annual Meeting

REGENXBIO Inc. announced the presentation of new interim data regarding the investigational gene therapy ABBV-RGX-314 at the American Academy of Ophthalmology 2024 Annual Meeting. The data will cover bilateral dosing in patients with wet age-related macular degeneration (AMD) and further studies on suprachoroidal delivery and long-term results. These findings will showcase the potential of ABBV-RGX-314 as a one-time treatment for various ophthalmic diseases, advancing REGENXBIO’s commitment to gene therapy innovations.

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RGNX
Sep 23, 2024
RGNXConferences/Events

REGENXBIO to Participate in Chardan

REGENXBIO Inc. announced its participation in Chardan's 8th Annual Genetic Medicines Conference scheduled for September 30, 2024, in New York. The event will feature a fireside chat accessible via a live webcast on the company's investor relations website. REGENXBIO focuses on developing AAV Therapeutics for retinal and rare diseases and has established a notable presence in the gene therapy field since its inception in 2009.

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RGNX
Sep 17, 2024
RGNXGeneral

REGENXBIO Appoints Mitchell Chan as Chief Financial Officer &#x2022; Life sciences veteran Mitchell Chan joins the company ahead of multiple catalysts across late-stage gene therapy programs &#x2022; Vit Vasista steps do

REGENXBIO has appointed Mitchell Chan as the new Chief Financial Officer, effective immediately. Chan, a seasoned finance executive with nearly 20 years of experience in the biotechnology industry, succeeds Vit Vasista, who steps down after over 15 years with the company. The appointment is viewed positively as REGENXBIO prepares for several key developments in its gene therapy pipeline, which aims to address significant health challenges. Vasista will remain as an advisor during the transition period until January 2025.

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RGNX
Sep 3, 2024
RGNXPhases

REGENXBIO Announces Positive Data from Pivotal Dose Level of RGX-121 Demonstrating Long-Term Systemic Effect

REGENXBIO Inc. reported positive findings from the pivotal phase of the CAMPSIITE trial for RGX-121, a potential gene therapy for Mucopolysaccharidosis Type II (MPS II). The trial indicated long-term reductions in cerebrospinal fluid levels of HS D2S6, a critical biomarker for the disease, with 80% of patients achieving freedom from enzyme replacement therapy. The company is moving forward with a rolling Biologics License Application expected to be submitted in Q3 2024, highlighting RGX-121's potential as a groundbreaking treatment for patients with neuronopathic MPS II.

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RGNX
Aug 27, 2024
RGNXConferences/Events

REGENXBIO Announces Presentation at the Society for the Study of Inborn Errors of Metabolism (SSIEM) 2024 Annual Symposium

REGENXBIO Inc. announced that it will present data from its RGX-121 program for the treatment of mucopolysaccharidosis type II (MPS II) at the SSIEM 2024 Annual Symposium in Porto, Portugal. The presentation is scheduled for September 4, 2024, and will include an interim clinical update on the investigational gene therapy RGX-121. This announcement emphasizes REGENXBIO's commitment to advancing gene therapy for rare genetic disorders.

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RGNX
Aug 8, 2024
RGNXConferences/Events

REGENXBIO to Participate in the H.C. Wainwright 4th Annual Ophthalmology Virtual Conference

REGENXBIO Inc. has announced its participation in the H.C. Wainwright 4th Annual Ophthalmology Virtual Conference scheduled for August 15, 2024. The conference will include a panel discussing the evolving therapeutic landscape of Age-related Macular Degeneration (AMD). Attendees can access a live webcast of the panel via REGENXBIO's website, with replays available for 30 days post-event. REGENXBIO is recognized for its pioneering work in AAV Therapeutics and its ongoing pipeline aimed at treating retinal and rare diseases.

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RGNX
Aug 1, 2024
RGNXPhases

REGENXBIO Reports Second Quarter 2024 Financial Results and Recent Operational Highlights &#x2022; Company remains on track for its first BLA filing in 2024 and is accelerating progress toward pivotal trial initiation fo

REGENXBIO reported its financial results for Q2 2024, highlighting significant advancements in its late-stage pipeline, including a planned BLA filing for RGX-121 later this year. The company announced promising data from the AFFINITY DUCHENNE trial for RGX-202, with high expression of microdystrophin in treated patients. Operational highlights also included a successful End-of-Phase II meeting with the FDA for RGX-202, supporting its pivotal trial initiation. REGENXBIO's cash position stands at $327 million, providing a solid runway for operations through 2026.

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RGNX
Aug 1, 2024
RGNXPhases

REGENXBIO ANNOUNCES NEW POSITIVE DATA FROM AFFINITY DUCHENNE® TRIAL OF RGX-202

REGENXBIO has announced new positive data from its Phase I/II AFFINITY DUCHENNE® trial for RGX-202, an investigational gene therapy for Duchenne muscular dystrophy in children aged 1 to 11. Interim results show robust microdystrophin expression in patients, with levels reaching 77.2% and 46.5% of control in younger patient groups. The company expects to initiate a pivotal trial in Q4 2024, reinforcing its belief in RGX-202 as a leading treatment option for Duchenne. Enrollment for further cohorts is in progress, and AU future data is anticipated later in the year.

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RGNX
Jul 25, 2024
RGNXConferences/Events

REGENXBIO to Host Conference Call on August 1 to Discuss Second Quarter 2024 Financial Results and Recent Operational Highlights

REGENXBIO Inc. has announced a conference call scheduled for August 1, 2024, to discuss its financial results for the second quarter and operational highlights. This call will be accessible to both domestic and international participants via phone and webcast. REGENXBIO is recognized for its pioneering work in gene therapy, particularly through its AAV Therapeutics pipeline aimed at treating various diseases. The conference will provide insights into the company's progress and future directions.

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RGNX
Jun 24, 2024
RGNXPhases

REGENXBIO Announces Expansion of AFFINITY DUCHENNE® Trial to Include a New Cohort of Younger Patients

REGENXBIO has announced an expansion of its AFFINITY DUCHENNE trial to include a new cohort of patients aged 1-3 years, aiming to evaluate the safety and efficacy of RGX-202 for Duchenne muscular dystrophy. The company expects that data from this younger cohort will be integral to its pivotal plans and upcoming BLA filing. The anticipated pivotal trial initiation is projected for late Q3 to early Q4 2024, following a scheduled end-of-Phase II meeting with the FDA. With distinguished features and strong initial data, RGX-202 represents a promising advancement in gene therapy for Duchenne patients.

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RGNX
Jun 18, 2024
RGNXFDA Updates

REGENXBIO Announces Successful Pre-BLA Meeting with FDA to Support Accelerated Approval Pathway for RGX-121 for the Treatment of MPS II

REGENXBIO has announced the successful completion of a Pre-BLA meeting with the FDA for RGX-121, aimed at treating MPS II. The FDA is aligned with REGENXBIO's plans for a rolling Biologics License Application submission starting in Q3 2024. Positive data from the pivotal CAMPSIITE trial will be incorporated into the BLA submission. The company is also preparing for a confirmatory trial expected to begin in the latter half of 2025.

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RGNX
Jun 12, 2024
RGNXGeneral

REGENXBIO Announces Leadership Transition

REGENXBIO Inc. has announced a leadership transition, appointing Curran Simpson as President and CEO, effective July 1, 2024. Kenneth T. Mills, the co-founder, will transition to Chairman of the Board after 15 years in the CEO role. The company believes this change will enhance its strategic direction and strengthen its AAV Therapeutics platform, which is aimed at advancing gene therapy for retinal and rare diseases. The board expresses confidence in Simpson's leadership skills to drive future value creation for the company and its stakeholders.

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RGNX
Jun 12, 2024
RGNXGeneral

REGENXBIO Announces Leadership Transition - Curran Simpson, Chief Operating Officer, Appointed as President and CEO - Co-Founder Kenneth T. Mills to Step Down as President and CEO; Named Chairman of the Board ROCKVILLE,

REGENXBIO Inc. has announced a leadership transition with Curran Simpson appointed as President and CEO, taking over from co-founder Kenneth T. Mills who will become Chairman of the Board. This change is effective July 1, 2024, and is aimed at positioning the company for its next growth phase as it advances its pipeline of gene therapies. REGENXBIO also reiterated its financial guidance, reporting a cash balance anticipated to fund operations through 2026, while continuing to develop its AAV Therapeutics.

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RGNX
Jun 5, 2024
RGNXConferences/Events

REGENXBIO to Participate in the Goldman Sachs 45th Annual Global Healthcare Conference

REGENXBIO Inc. has announced its participation in the Goldman Sachs 45th Annual Global Healthcare Conference, scheduled for June 12, 2024. This participation emphasizes the company's role in advancing gene therapy solutions, particularly through its AAV Therapeutics pipeline. Key presentations will be made available via a live webcast, promoting accessibility to investors and stakeholders. REGENXBIO is recognized for pioneering innovative gene therapies targeting various conditions.

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RGNX
May 8, 2024
RGNXGeneral

REGENXBIO Reports First Quarter 2024 Financial Results and Recent Operational Highlights &#x2022; Company remains on track for its first BLA filing in 2024 and is accelerating progress toward pivotal trial initiation for

REGENXBIO reported its financial results for the first quarter of 2024, revealing a strategic trajectory toward filing its first Biologics License Application (BLA) within the year. The company demonstrated significant progress with its RGX-202 candidate for Duchenne, including new positive interim data, and prepared for upcoming discussions with the FDA. Additionally, the ALTITUDE trial for diabetic retinopathy showed promising interim results, prompting plans for pivotal trials. Despite a decrease in revenue and a net loss, REGENXBIO's cash reserves are projected to support operations through 2026.

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RGNX
May 1, 2024
RGNXConferences/Events

REGENXBIO to Host Conference Call on May 8 to Discuss First Quarter 2024 Financial Results and Recent Operational Highlights

REGENXBIO Inc. has scheduled a conference call for May 8, 2024, to discuss its financial results for the first quarter ending March 31, 2024, along with recent operational highlights. Listeners can register for the call via provided links, and a replay will be available shortly after the event. REGENXBIO, known for its advancements in gene therapy, is developing several innovative treatments for retinal and rare diseases. The company's AAV Therapeutics, including those developed in partnership with AbbVie, have the potential to significantly impact patient care.

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RGNX
Mar 28, 2024
RGNXPhases

REGENXBIO Announces Lancet Publication of Phase I/IIa Study Evaluating ABBV-RGX-314 as a One-Time Gene Therapy for Wet AMD

REGENXBIO announced the publication of positive results from a Phase I/IIa study of its gene therapy, ABBV-RGX-314, for treating wet age-related macular degeneration (AMD). The results, published in The Lancet, indicate that patients exhibited stable or improved vision and retinal anatomy up to two years post-treatment. This therapy aims to provide a long-lasting solution compared to traditional anti-VEGF injections, which require ongoing administration. Ongoing pivotal trials are expected to support applications for regulatory approval by late 2025 or early 2026.

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RGNX
Mar 27, 2024
RGNXConferences/Events

REGENXBIO to Participate in Cantor Fitzgerald

REGENXBIO Inc. has announced its participation in the upcoming Cantor Fitzgerald's Virtual DMD and Other Dystrophy Days on April 3, 2024. The event will feature a fireside chat at 9:50 a.m. EDT, which can be accessed through the company's website. REGENXBIO focuses on advancing gene therapy solutions, particularly AAV Therapeutics, to treat various retinal and rare diseases. The company's engagement in a virtual event highlights its commitment to informing stakeholders about its developments in the biotechnology sector.

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RGNX
Mar 6, 2024
RGNXGeneral

REGENXBIO Announces Pricing of Upsized Public Offering of Common Stock and Pre-funded Warrants ROCKVILLE, Md.

REGENXBIO announced the pricing of an upsized public offering, which includes 4,565,260 shares of its common stock priced at $23.00 each and 1,521,740 pre-funded warrants priced at $22.9999 each. The total gross proceeds from this offering are anticipated to reach around $140 million, which is expected to close on March 11, 2024, subject to customary conditions. This offering allows REGENXBIO to maintain its focus on its gene therapy initiatives and pipeline advancements.

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RGNX
Mar 6, 2024
RGNXGeneral

REGENXBIO Announces Proposed Public Offering of Common Stock

REGENXBIO Inc. has announced a proposed public offering to sell $125 million of its common stock, contingent upon market conditions. The biotechnology company has engaged major financial institutions, including Morgan Stanley and Goldman Sachs, as underwriters for this offering. However, there remains uncertainty regarding the completion of the offering, as it is dependent on market conditions. REGENXBIO is recognized for its innovative work in gene therapy, particularly through its development of AAV Therapeutics.

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RGNX
Mar 5, 2024
RGNXPhases

REGENXBIO ANNOUNCES NEW POSITIVE INITIAL EFFICACY DATA FROM AFFINITY DUCHENNE® TRIAL

REGENXBIO Inc. announced positive initial efficacy data from its Phase I/II AFFINITY DUCHENNE trial for RGX-202, a gene therapy for Duchenne muscular dystrophy. The trial's initial assessment of a 12-year-old patient showed robust microdystrophin expression at 75.7% of control and early evidence of strength and motor function improvement. The company is committed to transparency, planning to initiate a pivotal trial in the second half of 2024 and is optimistic about RGX-202's potential as a new treatment option for Duchenne.

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RGNX
Feb 29, 2024
RGNXConferences/Events

REGENXBIO to Host Webcast Event to Discuss New Interim Clinical Data from the Phase I/II AFFINITY DUCHENNE® Trial

REGENXBIO Inc. is hosting a live webcast on March 5, 2024, to discuss new interim clinical data from its Phase I/II AFFINITY DUCHENNE trial for RGX-202, a treatment for Duchenne muscular dystrophy. The presentation will be led by Dr. Aravindhan Veerapandiyan and will also feature a Q&A session. The data will be made public ahead of its presentation at the MDA Clinical & Scientific Conference on March 6, 2024. This initiative reflects REGENXBIO's commitment to transparency and patient involvement in the clinical development process.

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RGNX
Feb 27, 2024
RGNXGeneral

REGENXBIO Reports Fourth Quarter and Full Year 2023 Financial Results and Recent Operational Highlights &#x2022; Focus on clinical stage AAV Therapeutic product candidates addressing large commercial opportunities and va

REGENXBIO Inc. has reported its financial results for Q4 and the full year of 2023, highlighting promising advancements in its AAV Therapeutics pipeline. The company expects to progress its clinical candidates towards pivotal trials and a Biologics License Application (BLA) filing as early as 2024. Positive data from recent trials, particularly in treatments for retinal diseases and Duchenne muscular dystrophy, were noted. However, the company also faces challenges, including a significant decline in royalty revenues from Zolgensma and increasing net losses.

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RGNX
Feb 21, 2024
RGNXConferences/Events

REGENXBIO to Host Conference Call on February 27 to Discuss Fourth Quarter and Full Year 2023 Financial Results and Recent Operational Highlights

REGENXBIO Inc. announced a conference call set for February 27, 2024, to discuss the financial results for the fourth quarter and full year of 2023. The company aims to provide updates on operational highlights as well. Listeners can register for the call, which will be available for replay on their investor website. REGENXBIO focuses on gene therapy, leveraging its NAV Technology Platform to develop a variety of treatment candidates across several therapeutic areas.

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RGNX
Feb 7, 2024
RGNXPhases

REGENXBIO Announces Pivotal Trial of RGX-121 for the Treatment of MPS II Achieves Primary Endpoint

REGENXBIO has announced positive topline results from the pivotal Phase I/II/III CAMPSIITE trial for RGX-121, a gene therapy targeting MPS II. The trial achieved its primary endpoint, demonstrating a significant reduction in a key biomarker, which indicates a potential improvement in neurodevelopmental function. The company plans to pursue a Biologics License Application (BLA) in 2024, leveraging the accelerated approval pathway from the FDA. These results mark a significant advance in treatment options for patients with this debilitating rare disease.

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RGNX
Feb 7, 2024
RGNXPhases

REGENXBIO Announces Completion of Enrollment in Cohort 2 and Additional Positive Interim Data in AFFINITY DUCHENNE® Trial

REGENXBIO has announced the completion of enrollment in cohort 2 of its Phase I/II AFFINITY DUCHENNE trial for RGX-202, targeting Duchenne muscular dystrophy. Interim results highlight a significant increase in microdystrophin expression levels in treated patients, with one patient showing an expression level of 83.4% compared to control. The company is on track to begin a pivotal trial in the latter half of 2024 and is actively preparing for a Biologics License Application (BLA) submission based on these results. The interim safety and efficacy data suggest a well-tolerated therapeutic approach across the study group.

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RGNX
Jan 31, 2024
RGNXConferences/Events

REGENXBIO Announces Presentations at the 20th Annual WORLDSymposium 2024

REGENXBIO Inc. announced that it will present pivotal topline results from the CAMPSIITE trial of RGX-121 for mucopolysaccharidosis type II (MPS II) at the 20th Annual WORLDSymposium 2024. Key presentations will occur on February 7, 2024, where interim updates and caregiver perspectives will be shared. The company is also planning to utilize an accelerated approval pathway to file a Biologics License Application within the year, emphasizing their commitment to advancing gene therapies for complex diseases.

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RGNX
Jan 16, 2024
RGNXPhases

REGENXBIO Announces Positive Interim Data from Phase II AAVIATE® Trial of ABBV-RGX-314 for the Treatment of Wet AMD Using Suprachoroidal Delivery

REGENXBIO announced positive interim results from its Phase II AAVIATE trial for ABBV-RGX-314, a one-time gene therapy treatment for wet AMD. The trial demonstrated a significant 80% reduction in the annual injection rate of anti-VEGF therapy, with no serious adverse events reported among the patients. The therapy aims to provide sustained vision health while addressing the treatment burden associated with chronic injections. The latest data suggests promising potential for ABBV-RGX-314 in the management of wet AMD and possibly other retinal diseases.

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RGNX
Jan 10, 2024
RGNXConferences/Events

REGENXBIO Announces Presentation at the Hawaiian Eye and Retina 2024 Meeting

REGENXBIO Inc. announced that it will present data from its Phase II AAVIATE trial of ABBV-RGX-314 for treating wet age-related macular degeneration (AMD) at the Hawaiian Eye and Retina 2024 Meeting in Maui. The presentation is scheduled for January 16, 2024, and will be led by Dr. John D. Pitcher, III. Following the presentation, the company will host a conference call to discuss the results and the ABBV-RGX-314 program further. This trial is part of REGENXBIO's broader commitment to gene therapy and its 5x'25 strategy.

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RGNX
Jan 8, 2024
RGNXGeneral

U.S. District Court Issues Decision on REGENXBIO and University of Pennsylvania NAV® Technology Patent Infringement Lawsuit

REGENXBIO Inc. announced that the U.S. District Court for the District of Delaware ruled in favor of Sarepta Therapeutics regarding a patent infringement lawsuit linked to a University of Pennsylvania patent. The court granted summary judgment on the invalidity of the patent, which pertains to technologies used by Sarepta for producing gene therapies. REGENXBIO intends to appeal this decision, asserting that it will continue to defend its patent rights vigorously. The ruling does not affect REGENXBIO's current licenses or therapeutic pipeline, but raises questions about the company’s ability to enforce its intellectual property effectively.

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RGNX
Nov 29, 2023
RGNXPhases

REGENXBIO Announces Dose Escalation in AFFINITY DUCHENNE® Trial

REGENXBIO announced the successful administration of RGX-202 at dose level 2 in the Phase I/II AFFINITY DUCHENNE trial, marking a significant milestone towards the drug's development. RGX-202 aims to treat Duchenne muscular dystrophy through a novel microdystrophin and is expected to support pivotal dose determination by 2024. Early biomarker results indicate favorable microdystrophin expression, with the company optimistic about RGX-202's potential in the market. The trial design includes a comprehensive safety assessment and is guided by inputs from the Duchenne community.

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RGNX
Nov 8, 2023
RGNXGeneral

REGENXBIO Announces Updated Strategic Plans and Third Quarter 2023 Financial Results &#x2022; Announces pipeline prioritization and corporate restructuring to focus on clinical stage AAV Therapeutic product candidates ad

REGENXBIO has updated its strategic plans with a focus on prioritizing its clinical stage AAV therapeutics, including ABBV-RGX-314, RGX-202, and RGX-121. The company will undergo corporate restructuring, resulting in a 15% workforce reduction, which is expected to yield savings of at least $100 million over the next two years. Amidst these changes, REGENXBIO reported a strong cash position of $365 million as of September 30, 2023, which will support its operations into the second half of 2025. The company aims to continue its focus on significant therapeutic opportunities while streamlining its operations.

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RGNX
Nov 3, 2023
RGNXPhases

REGENXBIO Presents Positive One Year Data from Phase II ALTITUDE® Trial of ABBV-RGX-314 for Treatment of Diabetic Retinopathy Using Suprachoroidal Delivery

REGENXBIO announced positive results from the Phase II ALTITUDE trial of ABBV-RGX-314, a gene therapy for diabetic retinopathy, showing significant clinical improvements at one year. The treatment demonstrated a reduction in disease progression and vision-threatening events among patients receiving the higher dose. Notably, 70.8% of patients experienced improvement on the Diabetic Retinopathy Severity Scale, and the therapy was well tolerated without serious drug-related adverse events. These findings emphasize the potential of ABBV-RGX-314 as a one-time treatment option in addressing diabetic retinopathy's challenges.

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RGNX
Nov 1, 2023
RGNXConferences/Events

REGENXBIO to Host Conference Call on November 8 to Discuss Third Quarter 2023 Financial Results and Recent Operational Highlights

REGENXBIO Inc. has announced it will host a conference call on November 8, 2023, to discuss its financial results for Q3 2023 and operational highlights. The call is scheduled for 4:30 p.m. EST, and participants can register for the webcast online. The company emphasizes its commitment to advancing its AAV Therapeutics pipeline and achieving its goal of progressing five candidates into pivotal-stage or commercial products by 2025.

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RGNX
Oct 30, 2023
RGNXConferences/Events

REGENXBIO Announces Presentations at the American Academy of Ophthalmology 2023 Annual Meeting

REGENXBIO Inc. has announced that it will be presenting new data on ABBV-RGX-314 at the American Academy of Ophthalmology (AAO) 2023 Annual Meeting in San Francisco, scheduled from November 3-6, 2023. The data will focus on the investigational gene therapy for the treatment of wet age-related macular degeneration and diabetic retinopathy. Notable presenters include Dr. Mark Barakat and Dr. Arshad Khanani, who will share results on the suprachoroidal delivery method. A conference call is also planned for November 6, 2023, to discuss these findings further.

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RGNX
Oct 5, 2023
RGNXConferences/Events

REGENXBIO to Participate in the Jefferies CNS/Neuro Summit

REGENXBIO Inc. has announced its participation in the upcoming Jefferies CNS/Neuro Summit scheduled for October 12, 2023, in New York City. The presentation will be accessible online via a live webcast, with an archived version available for approximately 30 days afterward. As a clinical-stage biotechnology firm specializing in gene therapy, REGENXBIO is focused on developing a range of innovative therapeutic solutions using its proprietary NAV Technology Platform.

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RGNX
Oct 3, 2023
RGNXPhases

REGENXBIO Presents Interim Clinical Data from Phase I/II AFFINITY DUCHENNE™ Trial of RGX-202 at 28th Annual International Congress of the World Muscle Society

REGENXBIO Inc. has presented interim clinical data from the Phase I/II AFFINITY DUCHENNE trial of its investigational gene therapy, RGX-202, for Duchenne Muscular Dystrophy (Duchenne). Interim results indicate the therapy is well-tolerated with no drug-related serious adverse events and shows promising microdystrophin expression in muscle tissue. Initial data from two patients reveal a notable reduction in serum creatine kinase levels and a significant increase in microdystrophin expression. The company anticipates further dose escalation and the initiation of a pivotal program in 2024, aligning with plans to support a Biologics License Application using RGX-202 as a surrogate endpoint.

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RGNX
Sep 26, 2023
RGNXConferences/Events

REGENXBIO Announces Presentations at the 28th Annual Congress of the World Muscle Society

REGENXBIO Inc. has announced that it will present at the 28th Annual Congress of the World Muscle Society in Charleston, SC, from October 3-7, 2023. The presentations will include interim data from the Phase I/II AFFINITY DUCHENNE trial, highlighting safety and microdystrophin protein levels over three months. Senior Director Jahannaz Dastgir and Dr. Aravindhan Veerapandiyan will lead the discussions on the investigational gene therapy for Duchenne muscular dystrophy. A conference call is scheduled for October 3, 2023, to provide further details on the interim data.

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RGNX
Aug 30, 2023
RGNXPhases

Initial Clinical Data of First Pediatric CLN2 Patient Dosed with RGX-181 Presented at SSIEM Annual Symposium

Initial clinical data from REGENXBIO's investigator-initiated trial of RGX-181, targeting late-infantile neuronal ceroid lipofuscinosis type 2 (CLN2), reveal that the therapy was well tolerated and led to a significant 86% reduction in seizure frequency. Observations also indicated notable improvements in neurodevelopmental skills over six months. The study involved a five-year-old participant following a single intracisternal dose and showed sustained gene expression of the TPP1 enzyme responsible for the disease. The results suggest RGX-181 holds potential as a one-time gene therapy for CLN2, a condition currently lacking effective treatments.

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RGNX
Aug 23, 2023
RGNXConferences/Events

REGENXBIO Announces Presentations at the Society for the Study of Inborn Errors of Metabolism Annual Symposium 2023

REGENXBIO Inc. has announced that it will present at the Society for the Study of Inborn Errors of Metabolism Annual Symposium 2023 in Jerusalem. The presentations will feature interim clinical trial data from its investigational AAV Therapeutics targeting rare neurodegenerative lysosomal storage disorders. Notably, the data will include findings from RGX-181 for treating CLN2 disease and other gene therapies addressing mucopolysaccharidosis types I and II. These presentations highlight REGENXBIO's commitment to advancing its clinical pipeline.

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RGNX
Aug 2, 2023
RGNXGeneral

REGENXBIO Reports Second Quarter 2023 Financial Results and Recent Operational Highlights &#x2022; Continued progress on &#x2018;5x'25' strategy to advance five AAV Therapeutics from REGENXBIO's internal pipeline and lic

REGENXBIO Inc. reported its second-quarter 2023 financial results and operational updates, showcasing progress on its 5x'25 strategy, which aims to advance five gene therapies by 2025. The company announced positive interim results from the ABBV-RGX-314 program for treating wet AMD and diabetic retinopathy, with zero cases of intraocular inflammation in the Phase II trials. Additionally, REGENXBIO successfully completed enrollment for its RGX-121 trial for MPS II and indicated that it is on track for a BLA filing in 2024. The company reported a robust financial position, with $415 million available to support its operations into 2025.

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RGNX
Aug 1, 2023
RGNXConferences/Events

REGENXBIO Announces Participation at the 2023 Wedbush PacGrow Healthcare Conference

REGENXBIO Inc. announced its participation in the 2023 Wedbush PacGrow Healthcare Conference, which is set for August 8, 2023. The company will host one-on-one meetings with investors during the event. REGENXBIO focuses on gene therapy, utilizing its proprietary NAV Technology Platform to develop various therapeutic candidates. The company aims to progress five AAV Therapeutics into pivotal-stage or commercial products by 2025 as part of its growth strategy.

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RGNX
Jul 26, 2023
RGNXConferences/Events

REGENXBIO to Host Conference Call on August 2 to Discuss Second Quarter 2023 Financial Results and Recent Operational Highlights

REGENXBIO Inc. announced a conference call on August 2, 2023, to review its financial results for the second quarter of 2023 and highlight recent operational achievements. The company provides a proprietary NAV Technology Platform for gene therapy applications, having exclusive rights to over 100 AAV vectors. REGENXBIO's strategy aims to advance multiple candidates into pivotal stages or commercial products by 2025. Interested participants can register for the call through designated links provided by the company.

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RGNX
Jul 24, 2023
RGNXConferences/Events

REGENXBIO Announces Upcoming Presentations at the American Society of Retina Specialists Annual Scientific Meeting

REGENXBIO Inc. has announced three presentations at the upcoming American Society of Retina Specialists Annual Scientific Meeting in Seattle, focusing on their investigational therapy ABBV-RGX-314. These presentations will provide data from several studies relating to the treatment of wet AMD and diabetic retinopathy. The research emphasizes the innovative delivery methods and the potential of gene therapy in addressing chronic retinal conditions. The meeting is scheduled from July 28 to August 1, 2023.

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RGNX
Jul 11, 2023
RGNXConferences/Events

REGENXBIO Highlights AAV Pipeline with Interim Results from Retinal and Duchenne Programs at its Virtual Investor Day on July 11, 2023

REGENXBIO Inc. presented interim results from its AAV pipeline, highlighting successful outcomes from the Phase II AAVIATE and ALTITUDE trials, which demonstrated no cases of intraocular inflammation in patients treated for retinal diseases. The company also shared updates on its Duchenne muscular dystrophy programs, reporting initial safety results from RGX-202 and announcing a new innovative exon-skipping approach with potential for significant benefits. The updates were delivered during a virtual Investor Day emphasizing REGENXBIO's commitment to advancing gene therapy solutions.

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RGNX
Jun 27, 2023
RGNXConferences/Events

REGENXBIO to Host Virtual Investor Day Highlighting AAV Pipeline Programs with Upcoming Interim Trial Updates

REGENXBIO Inc. announced a virtual investor day scheduled for July 11, 2023, focusing on its AAV pipeline programs. Management and external experts will discuss updates on key areas, including treatments for Wet AMD, Diabetic Retinopathy, and Duchenne Muscular Dystrophy. The event will showcase interim clinical trial data expected in the latter half of 2023, and feature detailed presentations of the ABBV-RGX-314 and RGX-202 programs. Attendees will also learn about the capabilities of the company's Manufacturing Innovation Center, which supports its production efforts.

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RGNX
Jun 20, 2023
RGNXGeneral

REGENXBIO and University of Pennsylvania File NAV® Technology Patent Infringement Lawsuit

REGENXBIO Inc. has filed a second patent infringement lawsuit against Sarepta Therapeutics concerning SRP-9001, alleging unauthorized use of its licensed technology. The complaint cites U.S. Patent No. 11,680,274 and seeks damages to compensate REGENXBIO and its licensor, the University of Pennsylvania. A previous lawsuit involving another patent related to Sarepta's technology is currently pending. REGENXBIO emphasizes its commitment to protecting its intellectual property while continuing to develop its gene therapy products.

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RGNX
Jun 1, 2023
RGNXConferences/Events

REGENXBIO Announces Presentation at the Jefferies Global Healthcare Conference

REGENXBIO Inc. announced its participation in the Jefferies Global Healthcare Conference, scheduled for June 8, 2023, where it will present its updates and host one-on-one investor meetings. The company aims to capitalize on opportunities to connect with investors and showcase its gene therapy pipeline. A live webcast of the presentation will be available on its website, along with an archived version for approximately 30 days post-event. This event aligns with REGENXBIO's strategy to promote its innovative AAV gene delivery platform.

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RGNX
May 23, 2023
RGNXFDA Updates

REGENXBIO Receives FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for RGX-121 Gene Therapy for Hunter Syndrome

REGENXBIO Inc. has received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA for its gene therapy RGX-121, aimed at treating Mucopolysaccharidosis Type II (MPS II), also known as Hunter syndrome. The RMAT designation supports the expedited development and review process of this therapy, indicating its potential to address unmet medical needs. The ongoing CAMPSIITE™ trial is evaluating RGX-121's effectiveness with encouraging interim data showing well-tolerated outcomes among participants. The company plans to file a Biologics License Application (BLA) in 2024 using an accelerated approval pathway.

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RGNX
May 22, 2023
RGNXConferences/Events

REGENXBIO Announces Presentation at the Barclays Gene Editing & Therapy Summit 2023

REGENXBIO Inc. has announced its participation in the Barclays Gene Editing & Therapy Summit 2023, where it will present a fireside chat and host investor meetings. The event is scheduled for May 24, 2023, and will cover important topics in genomic medicines. REGENXBIO aims to showcase its innovative NAV Technology Platform and its efforts towards advancing gene therapy treatments. The live webcast of the presentation will be accessible on REGENXBIO's website.

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RGNX
May 16, 2023
RGNXPhases

REGENXBIO Announces NAV® Technology Platform Will Support Bespoke Gene Therapy Consortium

REGENXBIO announced that its research on Mucopolysaccharidosis type IVA (MPS IVA) has been included in the Bespoke Gene Therapy Consortium’s clinical trial portfolio. This program, which aims to expedite the development and regulatory approval of gene therapies for rare diseases, includes partnerships with notable organizations like the NIH and FDA. REGENXBIO will provide licenses to its NAV® Technology Platform to support these initiatives. The move underscores the company's commitment to expanding access to innovative gene therapies for patients with rare genetic disorders.

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RGNX
May 3, 2023
RGNXGeneral

REGENXBIO Reports First Quarter 2023 Financial Results and Recent Operational Highlights - Continued progress on &#x2018;5x'25' strategy to advance five AAV Therapeutics from REGENXBIO's internal pipeline and licensed pr

REGENXBIO Inc. reported its financial results for Q1 2023, highlighting progress in its '5x'25' strategy aimed at advancing five AAV Therapeutics. Key updates included the successful transfer of investigational gene therapy ABBV-RGX-314 to AbbVie, which is expected to lead pivotal trials for chronic retinal diseases. The company also completed enrollment in expansion cohorts for several ongoing trials and anticipates significant updates later in the year. With $474 million in cash, REGENXBIO is well-positioned for continued development through 2025.

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RGNX
May 2, 2023
RGNXConferences/Events

REGENXBIO Announces Presentations at the American Society of Gene & Cell Therapy 26th Annual Meeting

REGENXBIO Inc. has announced its participation in the ASGCT 26th Annual Meeting, where it will present various studies related to gene therapy. The presentations demonstrate the company's progress with its proprietary NAV Technology Platform and its commitment to advancing gene therapies for several indications. Key presentations will focus on therapies for Duchenne Muscular Dystrophy and neuronopathic mucopolysaccharidosis among others. This meeting represents an opportunity for REGENXBIO to highlight significant pre-clinical and clinical advancements in gene therapy.

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RGNX
Apr 26, 2023
RGNXConferences/Events

REGENXBIO to Host Conference Call on May 3 to Discuss First Quarter 2023 Financial Results and Recent Operational Highlights

Regenxbio Inc. has announced a conference call scheduled for May 3, 2023, to discuss its first quarter 2023 financial results and operational developments. The call will be accessible via a webcast, with instructions provided for analysts wishing to participate in the Q&A session. The company highlights its commitment to advancing gene therapy through its NAV Technology Platform and aims to progress five therapeutic programs into pivotal or commercial stages by 2025.

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RGNX
Apr 18, 2023
RGNXConferences/Events

REGENXBIO Announces Presentation at Chardan

REGENXBIO Inc. has announced that it will participate in a fireside chat at Chardan's 7th Annual Genetic Medicines and Cell Therapy Manufacturing Summit on April 25, 2023. The session will be conducted virtually, and a live webcast will be available on the company’s website. This presentation is part of REGENXBIO's ongoing commitment to addressing investor interests and showcasing its progress in gene therapy.

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RGNX
Apr 11, 2023
RGNXFDA Updates

REGENXBIO Receives FDA Fast Track Designation for RGX-202, a Novel Gene Therapy Candidate for the Treatment of Duchenne Muscular Dystrophy

REGENXBIO Inc. has been granted Fast Track designation by the FDA for RGX-202, a one-time gene therapy candidate aimed at treating Duchenne muscular dystrophy. The therapy utilizes the company's proprietary AAV8 vector and an optimized transgene for a novel microdystrophin. The Phase I/II AFFINITY DUCHENNE trial is currently recruiting patients, with initial data anticipated later in 2023. This designation allows for more frequent interactions with the FDA and may accelerate RGX-202's pathway to market.

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RGNX
Feb 28, 2023
RGNXPhases

REGENXBIO Reports Fourth Quarter 2022 and Full-Year 2022 Financial Results and Recent Operational Highlights - Continued progress on &#x2018;5x'25' strategy to advance five AAV Therapeutics from REGENXBIO's internal pipe

REGENXBIO reported its fourth quarter and full-year 2022 financial results, highlighting ongoing progress in its '5x'25' strategy aimed at advancing five AAV Therapeutics. Key developments include the RGX-314 program, which is currently in pivotal trials for wet AMD and diabetic retinopathy, and strong cash reserves of $565 million. The company is focused on its clinical trials with significant milestones expected in 2023, including data updates from various trials, as well as plans for BLA submissions in 2024 for its lead candidates.

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RGNX
Feb 24, 2023
RGNXPhases

Additional Positive Interim Data from Phase I/II Trial of REGENXBIO

REGENXBIO Inc. announced positive interim data from its Phase I/II trial of RGX-111, a gene therapy for severe Mucopolysaccharidosis Type I. The data indicates RGX-111 is well-tolerated with no serious adverse events and shows encouraging biomarker activity in the central nervous system. Patients demonstrated significant neurodevelopmental skill acquisition, enhancing cognitive, language, and motor skills. The company plans to continue developing RGX-111 and expects to produce commercial-scale material to support ongoing trials.

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RGNX
Feb 22, 2023
RGNXPhases

Additional Positive Interim Data from Phase I/II/III CAMPSIITE™ Trial of REGENXBIO

REGENXBIO Inc. announced additional positive interim data from the Phase I/II/III CAMPSIITE™ trial of RGX-121, a one-time gene therapy for MPS II. The latest results show that RGX-121 is well-tolerated with no drug-related serious adverse events. Notably, patients demonstrated significant dose-dependent reductions in CSF GAGs, indicating potential long-term clinical benefits. Following encouraging outcomes, the company plans to file a Biologics License Application in 2024 via the accelerated approval pathway.

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RGNX
Feb 21, 2023
RGNXConferences/Events

REGENXBIO to Host Conference Call on February 28 to Discuss Fourth Quarter and Full Year 2022 Financial Results and Recent Operational Highlights

REGENXBIO Inc. announced that it will hold a conference call on February 28, 2023, to discuss its financial results for the fourth quarter and full year of 2022, alongside recent operational highlights. The call is set to start at 4:30 p.m. ET, and interested parties can register to participate. REGENXBIO emphasizes its commitment to advancing gene therapy through its NAV Technology Platform, aiming to progress multiple therapeutic candidates by 2025.

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RGNX
Feb 17, 2023
RGNXConferences/Events

REGENXBIO Announces Presentations at the 19th Annual WORLDSymposium™ 2023

REGENXBIO Inc. announced that it will present new interim data from its Phase I/II/III trial of RGX-121 and Phase I/II trial of RGX-111 at the 19th Annual WORLDSymposium™ in Orlando, Florida. The event will feature three oral presentations and eight posters, highlighting important findings in gene therapy treatments for mucopolysaccharidosis types I and II. Additionally, REGENXBIO will host a symposium session on gene therapy approaches for neuronopathic conditions.

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RGNX
Feb 11, 2023
RGNXPhases

REGENXBIO Presents Interim Data from Phase II Bridging Study Evaluating the Clinical Performance of RGX-314 Using the NAVXpress™ Manufacturing Platform Process

REGENXBIO Inc. presented interim data from a Phase II bridging study evaluating RGX-314, a potential one-time therapy for wet AMD, produced using the NAVXpress manufacturing platform. The results demonstrated that RGX-314 was well-tolerated and had a clinical profile comparable to that of previous manufacturing processes. The ongoing pivotal trials are set to support a BLA submission in 2024. Notably, the study highlighted RGX-314’s potential to provide sustained outcomes while minimizing the need for frequent injections in patients.

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RGNX
Feb 8, 2023
RGNXConferences/Events

REGENXBIO Announces Presentation at the Virtual SVB Securities Global Biopharma Conference

REGENXBIO Inc. has announced its participation in the upcoming SVB Securities Global Biopharma Conference scheduled for February 16, 2023. The presentation will be available via live webcast and will feature insights into the company's gene therapy advancements. REGENXBIO aims to leverage its proprietary NAV Technology Platform, which encompasses a variety of AAV vectors, to progress its pipeline towards pivotal-stage or commercial products by 2025. This event underscores the company's commitment to addressing unmet medical needs through innovative therapies.

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RGNX
Feb 6, 2023
RGNXConferences/Events

REGENXBIO Announces Presentations at the Angiogenesis, Exudation, and Degeneration 2023 Conference

REGENXBIO Inc. has announced three upcoming presentations related to RGX-314 at the Angiogenesis, Exudation, and Degeneration 2023 Conference. The conference will feature findings from a Phase II bridging study assessing the drug's pharmacodynamics, safety, and efficacy. These presentations aim to showcase advancements in gene therapy, particularly for conditions like neovascular age-related macular degeneration and diabetic retinopathy. The event will take place virtually from February 10-11, 2023.

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RGNX
Jan 23, 2023
RGNXPhases

REGENXBIO Announces Phase I/II Trial of RGX-202, a Novel Gene Therapy Candidate for Duchenne Muscular Dystrophy, is Active and Recruiting Patients

REGENXBIO has announced the initiation of the Phase I/II AFFINITY DUCHENNE trial to evaluate RGX-202, a novel gene therapy candidate aimed at treating Duchenne muscular dystrophy. The trial is designed to assess the safety, tolerability, and clinical efficacy of RGX-202 and is currently open for patient recruitment. Additionally, a new observational study named AFFINITY BEYOND is underway to evaluate the prevalence of AAV8 antibodies in boys with Duchenne, potentially informing future trials. The development of RGX-202 utilizes REGENXBIO's proprietary NAV AAV8 vector and focuses on delivering a transgene for a unique microdystrophin protein linked to muscle function improvement.

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RGNX
Jan 9, 2023
RGNXGeneral

REGENXBIO ANNOUNCES SENIOR LEADERSHIP PROMOTIONS

REGENXBIO Inc. has announced the promotion of Curran Simpson to Chief Operating Officer and Shiva Fritsch to Chief Communications Officer. These changes follow a year marked by significant advancements, including the opening of a Manufacturing Innovation Center and the ongoing development of several clinical programs. The company is targeting five AAV Therapeutics to advance to pivotal stages or commercial products by 2025. Their leadership is expected to guide REGENXBIO as it enters a new phase of growth.

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RGNX
Jan 9, 2023
RGNXGeneral

REGENXBIO ANNOUNCES SENIOR LEADERSHIP PROMOTIONS Curran Simpson has been appointed Chief Operating Officer Shiva Fritsch assumes the role of Chief Communications Officer ROCKVILLE, Md .

REGENXBIO Inc. has announced the promotion of Curran Simpson to Chief Operating Officer and Shiva Fritsch to Chief Communications Officer. These moves follow a significant year for the company, marked by the launch of its gene therapy Manufacturing Innovation Center and ongoing clinical program advancements aligned with its 5 x 25 strategy. Both leaders bring extensive experience to their new roles, which are expected to drive the company's operations and communications as it transitions into a near-commercial stage entity.

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RGNX
Jan 3, 2023
RGNXConferences/Events

REGENXBIO Announces Presentation at the 41st Annual J.P. Morgan Healthcare Conference

REGENXBIO Inc. has announced that it will be presenting at the upcoming 41st Annual J.P. Morgan Healthcare Conference on January 10, 2023. The presentation will include a fireside chat scheduled for 11:15 a.m. PT at the Westin St. Francis in San Francisco, CA. Attendees can access a live webcast of the chat, which will be archived for 30 days following the presentation. The company is focused on advancing gene therapy through its NAV Technology Platform, aiming to progress five AAV Therapeutics into pivotal-stage or commercial products by 2025.

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RGNX
Dec 21, 2022
RGNXGeneral

REGENXBIO Reports Update on Advancement of Programs for CLN2 Disease

RGX-181 and RGX-381 are potential one-time AAV Therapeutics for the treatment of the CNS and ocular manifestations of CLN2 disease, the most common form of Batten disease Patient dosed under a single-patient investigator-initiated study of RGX-181 Company announces approval of

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RGNX
Dec 8, 2022
RGNXPhases

REGENXBIO Announces Completion of Dosing in the Phase I/II Trial of RGX-111 for the Treatment of Severe MPS I

RGX-111 is an investigational AAV Therapeutic for the treatment of severe MPS I that is part of REGENXBIO's clinical-stage pipeline of neurodegenerative disease programs. Expanded Cohort 2 enrollment is complete; eight patients have received RGX-111 in the trial Company intends

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RGNX
Nov 3, 2022
RGNXPhases

REGENXBIO Presents Positive Interim Data from and the Expansion of Phase II ALTITUDE® Trial of RGX-314 for the Treatment of Diabetic Retinopathy Using Suprachoroidal Delivery

RGX-314 continues to be well tolerated in 50 patients from Cohorts 1-3 with no drug-related serious adverse events Patients treated with RGX-314 in Cohorts 1-3 demonstrated clinically meaningful improvements in disease severity and less disease worsening versus observation contr

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RGNX
Nov 3, 2022
RGNXGeneral

REGENXBIO Reports Third Quarter 2022 Financial Results and Recent Operational Highlights - Continued progress on 5x25 strategy to advance five AAV Therapeutics from our internal pipeline and licensed programs into pivota

REGENXBIO Reports Third Quarter 2022 Financial Results and Recent Operational Highlights -Continued progress on 5x25 strategy to advance five AAV Therapeutics from our internal pipeline and licensed programs into pivotal-stage or commercial products by 2025 -RGX-314 program for

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RGNX
Oct 27, 2022
RGNXPhases

REGENXBIO to Host Conference Call on November 3 to Discuss Third Quarter 2022 Financial Results, Recent Operational Highlights and Interim Data from Phase II ALTITUDE® Trial of RGX-314 for the Treatment of Diabetic Retinopathy

ROCKVILLE, Md., Oct. 27, 2022 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced that it will present data from the ALTITUDE® clinical trial evaluating RGX-314 using suprachoroidal delivery for the treatment of patients with diabetic retinopathy at the Retina Society 5

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RGNX
Oct 3, 2022
RGNXPhases

REGENXBIO Announces Additional Positive Interim Data from Trials of RGX-314 for the Treatment of Wet AMD

Company announced positive interim data from and the expansion of Phase II AAVIATE® trial of RGX-314 for the treatment of wet AMD using suprachoroidal delivery RGX-314 continues to be well tolerated in 85 patients from Cohorts 1-5 with no drug-related serious adverse events Mea

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RGNX
Sep 26, 2022
RGNXConferences/Events

REGENXBIO Announces Upcoming Presentations During the American Academy of Ophthalmology 2022 Annual Meeting

Company to host conference call on Monday, October 3rd at 8:30 a.m. ET to discuss new, interim data from the ongoing Phase II AAVIATE® trial ROCKVILLE, Md., Sept. 26, 2022 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced presentations at the American Academy of Opht

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RGNX
Aug 31, 2022
RGNXPhases

REGENXBIO Presents Additional Positive Interim Data from the Phase I/II/III CAMPSIITE™ Trial of RGX-121 for the Treatment of MPS II (Hunter Syndrome) at the Society for the Study of Inborn Errors of Metabolism (SSIEM) Annual Symposium

- New data in Cohort 3 using pivotal program dose level demonstrates largest median reduction in CSF GAGs, continuing to approach normal levels at 48 weeks - RGX-121, a one-time gene therapy for MPS II, continues to be well-tolerated with no drug-related SAEs across three dose l

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RGNX
Aug 23, 2022
RGNXConferences/Events

REGENXBIO Announces Presentations at the Society for the Study of Inborn Errors of Metabolism Annual Symposium

ROCKVILLE, Md., Aug. 23, 2022 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced presentations at the Society for the Study of Inborn Errors of Metabolism Annual Symposium, taking place from August 30 through September 2, 2022, in Freiburg, Germany. The presentations w

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RGNX
Aug 10, 2022
RGNXConferences/Events

REGENXBIO Announces Presentation at the H.C. Wainwright 2nd Annual Ophthalmology Virtual Conference

ROCKVILLE, Md., Aug. 10, 2022 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced that it will present at the H.C. Wainwright 2nd Annual Ophthalmology Virtual Conference on Wednesday, August 17th, 2022: Panel: Unique Delivery Technology Platforms for Better Compliance

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RGNX
Aug 3, 2022
RGNXGeneral

REGENXBIO Reports Second Quarter 2022 Financial Results and Recent Operational Highlights - RGX-314 program for the treatment of wet AMD and diabetic retinopathy, being developed in collaboration with AbbVie, remains on

REGENXBIO Reports Second Quarter 2022 Financial Results and Recent Operational Highlights ROCKVILLE, Md., Aug 3, 2022 (PRNewswire) -- REGENXBIO Inc. (Nasdaq: RGNX) today announced financial results for the second quarter ended June 30, 2022, and recent operational highlights. "

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RGNX
Aug 3, 2022
RGNXFDA Updates

REGENXBIO Announces Intention to File a Biologics License Application Using the Accelerated Approval Pathway for RGX-121, an AAV Therapeutic for the Treatment of MPS II

FDA will consider an accelerated approval pathway for RGX-121; BLA filing expected in 2024 Pivotal program is active and enrolling patients RGX-121 is a potential first-in-class, one-time gene therapy for the treatment of MPS II Internal cGMP manufacturing process expected to

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RGNX
Aug 1, 2022
RGNXConferences/Events

REGENXBIO to Host Conference Call on August 3 to Discuss Second Quarter 2022 Financial Results and Recent Operational Highlights

ROCKVILLE, Md., Aug. 1, 2022 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced that it will host a conference call on Wednesday, August 3, 2022, at 4:30 p.m. ET to discuss its financial results for the quarter ended June 30, 2022, and recent operational highlights. L

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RGNX
Jul 8, 2022
RGNXPhases

REGENXBIO Announces Enrollment Complete in Cohort 5 of Phase II AAVIATE® Trial

85 subjects dosed across five cohorts in AAVIATE® trial evaluating RGX-314 for the treatment of wet AMD using suprachoroidal delivery Company expects to report additional suprachoroidal data later this year ROCKVILLE, Md., July 8, 2022 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RG

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RGNX
Jun 9, 2022
RGNXGeneral

REGENXBIO Opens State-of-the-Art Gene Therapy Manufacturing Facility

In-house facility to produce NAV Technology-based AAV gene therapies at 2,000 liters scale $65 million invested in new facility, enabling end-to-end control of gene therapy manufacturing in Montgomery County, Maryland ROCKVILLE, Md., June 9, 2022 /PRNewswire/ -- REGENXBIO Inc.

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RGNX
Jun 7, 2022
RGNXGeneral

Jennifer Zachary Joins REGENXBIO Board of Directors ROCKVILLE, Md.

Jennifer Zachary Joins REGENXBIO Board of Directors ROCKVILLE, Md., June 7, 2022 (PRNewswire) REGENXBIO Inc. (Nasdaq: RGNX) today announced the appointment of Jennifer Zachary to its Board of Directors, effective June 3, 2022. Ms. Zachary will serve as a member of REGENXBIO s A

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RGNX
May 4, 2022
RGNXFDA Updates

REGENXBIO Reports First Quarter 2022 Financial Results and Recent Operational Highlights - Continues to advance RGX-314 program for the treatment of wet AMD and diabetic retinopathy; remains on track for first BLA filing

REGENXBIO Reports First Quarter 2022 Financial Results and Recent Operational Highlights ROCKVILLE, Md., May 4, 2022 (PRNewswire) -- REGENXBIO Inc. (Nasdaq: RGNX) today announced financial results for the first quarter ended March 31, 2022, and recent operational highlights. "W

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RGNX
May 3, 2022
RGNXConferences/Events

REGENXBIO Announces Presentations at the American Society of Gene & Cell Therapy (ASGCT) 25th Annual Meeting

ROCKVILLE, Md., May 3, 2022 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced presentations at the American Society of Gene & Cell Therapy (ASGCT) 25th Annual Meeting, taking place virtually and in Washington, D.C. from May 16 through 19, 2022. The presentations highl

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RGNX
Apr 27, 2022
RGNXConferences/Events

REGENXBIO to Host Conference Call on May 4 to Discuss First Quarter 2022 Financial Results and Recent Operational Highlights

ROCKVILLE, Md., April 27, 2022 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced that it will host a conference call on Wednesday, May 4, 2022, at 4:30 p.m. ET to discuss its financial results for the quarter ended March 31, 2022, and recent operational highlights. T

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RGNX
Mar 1, 2022
RGNXGeneral

REGENXBIO Reports Fourth Quarter and Full-Year 2021 Financial Results and Recent Operational Highlights - Closed eye care collaboration agreement with AbbVie to develop and commercialize RGX-314 o Received upfront paymen

REGENXBIO Reports Fourth Quarter and Full-Year 2021 Financial Results and Recent Operational Highlights ROCKVILLE, Md., March 1, 2022 (PRNewswire) -- REGENXBIO Inc. (Nasdaq: RGNX) today announced financial results for the fourth quarter ended December 31, 2021, and recent operat

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RGNX
Feb 22, 2022
RGNXConferences/Events

REGENXBIO to Host Conference Call on March 1 to Discuss Fourth Quarter and Full-Year 2021 Financial Results and Recent Operational Highlights

ROCKVILLE, Md., Feb. 22, 2022 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced that it will host a conference call on Tuesday, March 1, 2022, at 4:30 p.m. ET to discuss its financial results for the quarter and full-year ended December 31, 2021, and recent operationa

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RGNX
Feb 12, 2022
RGNXPhases

REGENXBIO Presents Positive Interim Data from Phase II ALTITUDE Trial of RGX-314 for the Treatment of Diabetic Retinopathy Using Suprachoroidal Delivery 47% of patients in Cohort 1 treated with RGX-314 demonstrated a 2 s

REGENXBIO Presents Positive Interim Data from Phase II ALTITUDE Trial of RGX-314 for the Treatment of Diabetic Retinopathy Using Suprachoroidal Delivery ROCKVILLE, Md., February 12, 2022 (PR Newswire) REGENXBIO Inc. (Nasdaq: RGNX) today announced additional positive interim dat

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RGNX
Feb 9, 2022
RGNXPhases

REGENXBIO Presents Additional Positive Interim Data from Phase I/II Trial of RGX-121 for the Treatment of MPS II (Hunter Syndrome) at 18 th Annual WORLD Symposium TM 2022 RGX-121, a one-time gene therapy for MPS II, cont

REGENXBIO Presents Additional Positive Interim Data from Phase I/II Trial of RGX-121 for the Treatment of MPS II (Hunter Syndrome) at 18th Annual WORLDSymposiumTM ROCKVILLE, Md., February 9, 2022 (PRNewswire) REGENXBIO Inc. (Nasdaq: RGNX) today announced additional positive inte

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RGNX
Feb 9, 2022
RGNXPhases

REGENXBIO Presents Positive Initial Data from Phase I/II Trial of RGX-111 for the Treatment of Severe MPS I at 18th Annual WORLDSymposium™ 2022

ROCKVILLE, Md., Feb. 9, 2022 /PRNewswire/ -- RGX-111, a potential one-time gene therapy for MPS I, is well-tolerated across two dose levels, with no drug-related serious adverse events Biomarker and neurodevelopmental assessments indicate encouraging CNS profile in patients dos

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RGNX
Feb 8, 2022
RGNXConferences/Events

REGENXBIO Announces Presentations at the 11th Annual SVB Leerink Global Healthcare Conference

ROCKVILLE, Md., Feb. 8, 2022 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced it will present in a fireside chat at the 11th Annual SVB Leerink Global Healthcare Conference on Wednesday, February 16, 2022 at 8:40 a.m. ET. The conference will be held in a virtual meet

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RGNX
Feb 4, 2022
RGNXConferences/Events

REGENXBIO Announces Presentations at the Angiogenesis, Exudation, and Degeneration 2022 Conference

ROCKVILLE, Md., Feb. 4, 2022 /PRNewswire/ -- Data for Cohort 1 with six months of follow-up from the Phase II ALTITUDE™ trial of RGX-314 for the treatment of diabetic retinopathy to be presented REGENXBIO Inc. (Nasdaq: RGNX) today announced that three oral presentations, includ

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RGNX
Jan 31, 2022
RGNXConferences/Events

REGENXBIO Announces Presentations at the 18th Annual WORLDSymposium™ 2022

ROCKVILLE, Md., Jan. 31, 2022 /PRNewswire/ -- Interim data from Phase I/II trials of RGX-121 for the treatment of MPS II and RGX-111 for the treatment of MPS I to be presented REGENXBIO Inc. (Nasdaq: RGNX) today announced that five oral and seven poster presentations will be pr

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RGNX
Jan 10, 2022
RGNXPhases

REGENXBIO Announces Initiation of Second Pivotal Trial in RGX-314 Clinical Program for the Treatment of Wet AMD Using Subretinal Delivery

ROCKVILLE, Md., Jan. 10, 2022 /PRNewswire/ -- ASCENTTM, a Phase III clinical trial conducted in partnership with AbbVie, is expected to enroll patients in the United States and Canada Pivotal trials expected to support BLA submission for RGX-314 in 2024 REGENXBIO Inc. (Nasdaq:

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RGNX
Jan 6, 2022
RGNXFDA Updates

REGENXBIO Announces FDA Clearance of IND for Clinical Trial of RGX-202, a Novel Gene Therapy Candidate for Duchenne Muscular Dystrophy

ROCKVILLE, Md., Jan. 6, 2022 /PRNewswire/ -- Potential one-time gene therapy for the treatment of Duchenne includes a novel, optimized microdystrophin transgene and REGENXBIO's proprietary NAV® AAV8 vector Innovative trial design, including comprehensive immunosuppressive regim

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RGNX
Nov 22, 2021
RGNXFDA Updates

REGENXBIO Announces Orphan Drug Designation Granted to RGX-202, a Novel Gene Therapy Candidate for the Treatment of Duchenne Muscular Dystrophy

ROCKVILLE, Md., Nov. 22, 2021 /PRNewswire/ -- Potential one-time gene therapy for the treatment of Duchenne, includes a novel, optimized microdystrophin transgene and REGENXBIO's proprietary NAV® AAV8 vector Commercial-scale cGMP material to be used in clinical development Com

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RGNX
Nov 12, 2021
RGNXPhases

REGENXBIO Presents Additional Positive Interim Data from Trials of RGX-314 in Wet AMD and Diabetic Retinopathy Using Suprachoroidal Delivery at AAO 2021 Suprachoroidal delivery of RGX-314 in Phase II AAVIATE trial for th

REGENXBIO Presents Additional Positive Interim Data from Trials of RGX-314 in Wet AMD and Diabetic Retinopathy Using Suprachoroidal Delivery at AAO 2021 ROCKVILLE, Md., November 12, 2021 (PR Newswire) REGENXBIO Inc. (Nasdaq: RGNX) today announced additional positive interim dat

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RGNX
Nov 9, 2021
RGNXGeneral

REGENXBIO Announces Closing of Eye Care Collaboration Agreement with AbbVie ROCKVILLE, Md.

REGENXBIO Announces Closing of Eye Care Collaboration Agreement with ROCKVILLE, Md., November 9, 2021 REGENXBIO Inc. (Nasdaq: RGNX) today announced the closing of its Collaboration and License Agreement with AbbVie to develop and commercialize RGX-314, a potential one-time gene

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RGNX
Nov 5, 2021
RGNXConferences/Events

REGENXBIO Announces RGX-314 Data Presentation at the American Academy of Ophthalmology 2021 Annual Meeting

ROCKVILLE, Md., Nov. 5, 2021 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced that data from the RGX-314 clinical trials will be presented in an oral presentation at the American Academy of Ophthalmology 2021 Annual Meeting taking place in New Orleans, LA from Novemb

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RGNX
Nov 2, 2021
RGNXGeneral

REGENXBIO Reports Third Quarter 2021 Financial Results and Operational Highlights Announced eye care collaboration with AbbVie to develop and commercialize RGX-314 o AbbVie and REGENXBIO form a strategic partnership comb

REGENXBIO Reports Third Quarter 2021 Financial Results and Operational Highlights ROCKVILLE, Md., November 2, 2021 (PR Newswire) -- REGENXBIO Inc. (Nasdaq: RGNX) today announced financial results for the third quarter ended September 30, 2021, and recent operational highlights.

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RGNX
Oct 26, 2021
RGNXConferences/Events

REGENXBIO to Host Conference Call on November 2 to Discuss Third Quarter 2021 Financial Results and Recent Operational Highlights

ROCKVILLE, Md., Oct. 26, 2021 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced that it will host a conference call on Tuesday, November 2, 2021, at 4:30 p.m. ET to discuss its financial results for the quarter ended September 30, 2021, and recent operational highligh

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RGNX
Oct 9, 2021
RGNXPhases

REGENXBIO Presents Positive Initial Data from Phase II ALTITUDE Trial of RGX-314 for the Treatment of Diabetic Retinopathy Using Suprachoroidal Delivery at American Society of Retina Specialists Annual Meeting Suprachoro

REGENXBIO Presents Positive Initial Data from Phase II ALTITUDE Trial of RGX-314 for the Diabetic Retinopathy Using Suprachoroidal Delivery at American Society of Retina Specialists Annual Meeting ROCKVILLE, Md., October 9, 2021 (PR Newswire) REGENXBIO Inc. (Nasdaq: RGNX) tod

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RGNX
Oct 1, 2021
RGNXPhases

REGENXBIO Presents Positive Initial Data from Phase II AAVIATE Trial of RGX-314 for the Treatment of Wet AMD Using Suprachoroidal Delivery and Provides Trial Update at Retina Society 54 th Annual Scientific Meeting Supra

REGENXBIO Presents Positive Initial Data from Phase II AAVIATE Trial of RGX-314 for the Wet AMD Using Suprachoroidal Delivery and Provides Trial Update at Retina Society 54th Annual Scientific Meeting ROCKVILLE, Md., October 1, 2021 (PR Newswire) REGENXBIO Inc. (Nasdaq: RGNX)

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RGNX
Oct 1, 2021
RGNXConferences/Events

REGENXBIO Announces RGX-314 Data Presentations at American Society of Retina Specialists Annual Meeting

ROCKVILLE, Md., Oct. 1, 2021 /PRNewswire/ -- Data for Cohort 1 with three months of follow-up from the RGX-314 Phase II trial for the treatment of diabetic retinopathy (ALTITUDE®) to be presented REGENXBIO Inc. (Nasdaq: RGNX) today announced that data from the RGX-314 clinical

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RGNX
Sep 27, 2021
RGNXConferences/Events

REGENXBIO Announces RGX-314 Data Presentations at Retina Society 54th Annual Scientific Meeting and KOL Conference Call

ROCKVILLE, Md., Sept. 27, 2021 /PRNewswire/ -- Interim data for Cohort 1 with six months of follow-up from the RGX-314 Phase II trial for the treatment of wet AMD (AAVIATE®) to be presented REGENXBIO to host conference call and webcast to review the interim data from the AAVIAT

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RGNX
Sep 13, 2021
RGNXGeneral

AbbVie and REGENXBIO Announce Eye Care Collaboration AbbVie and REGENXBIO form a strategic partnership combining eye care and gene therapy expertise Companies will develop and commercialize RGX-314, an inve

and REGENXBIO Announce Eye Care Collaboration NORTH CHICAGO, Ill. and ROCKVILLE, Md., September 13, 2021 AbbVie (NYSE: ABBV) and REGENXBIO Inc. (Nasdaq: RGNX) today announced a partnership to develop and commercialize RGX-314, a potential one-time gene therapy for the treatment

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RGNX
Sep 7, 2021
RGNXGeneral

Dr. Jean Bennett and George Migausky Join REGENXBIO Board of Directors Renowned gene therapy pioneer and biotechnology executive bring extensive R&D leadership and financial and operational expertise to the Board ROCKVIL

Dr. Jean Bennett and George Migausky Join REGENXBIO Board of ROCKVILLE, Md., September 7, 2021 REGENXBIO Inc. (Nasdaq: RGNX) today announced the appointment of Jean Bennett, M.D., Ph.D., and George Migausky to its Board of Directors, effective September 3, 2021. Dr. Bennett, a

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RGNX
Aug 9, 2021
RGNXPhases

REGENXBIO Reports Second Quarter 2021 Financial Results and Operational Highlights Enrollment in RGX-314 programs is on-track, including the pivotal program for the treatment of wet AMD utilizing subretinal delivery, and

REGENXBIO Reports Second Quarter 2021 Financial Results and Operational Highlights ROCKVILLE, Md., August 9, 2021 (PR Newswire) -- REGENXBIO Inc. (Nasdaq: RGNX) today announced financial results for the second quarter ended June 30, 2021, and recent operational highlights. "We

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RGNX
Aug 2, 2021
RGNXConferences/Events

REGENXBIO to Host Conference Call on August 9 to Discuss Second Quarter 2021 Financial Results and Recent Operational Highlights

ROCKVILLE, Md., Aug. 2, 2021 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced that it will host a conference call on Monday, August 9, 2021, at 4:30 p.m. ET to discuss its financial results for the quarter ended June 30, 2021, and recent operational highlights. To a

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RGNX
May 14, 2021
RGNXPhases

REGENXBIO Presents Additional Positive Interim Data from Phase I/II Trial of RGX-121 for the Treatment of MPS II (Hunter Syndrome) at American Society of Gene and Cell Therapy

ROCKVILLE, Md., May 14, 2021 /PRNewswire/ -- RGX-121, a one-time gene therapy for MPS II, continues to be well-tolerated with no drug-related serious adverse events Biomarkers and measures of neurodevelopmental function from patients in Cohorts 1 and 2 continue to indicate CNS

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RGNX
May 6, 2021
RGNXConferences/Events

REGENXBIO to Present at Upcoming Investor Conferences

ROCKVILLE, Md., May 6, 2021 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced it will present at the following May investor conferences, which will each be held in a virtual meeting format: Bank of America Securities 2021 Virtual Health Care Conference Day Fireside

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RGNX
May 5, 2021
RGNXPhases

REGENXBIO Reports First Quarter 2021 Financial Results and Operational Highlights Enrollment ongoing in ATMOSPHERE , the first of two planned pivotal trials for the subretinal delivery of RGX-314 for the treatment of wet

REGENXBIO Reports First Quarter 2021 Financial Results and Operational Highlights ROCKVILLE, Md., May 5, 2021 (PR Newswire) -- REGENXBIO Inc. (Nasdaq: RGNX) today announced financial results for the first quarter ended March 31, 2021, and recent operational highlights. "In the

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RGNX
Apr 28, 2021
RGNXConferences/Events

REGENXBIO to Host Conference Call on May 5 to Discuss First Quarter 2021 Financial Results and Recent Operational Highlights

ROCKVILLE, Md., April 28, 2021 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced that it will host a conference call on Wednesday, May 5, 2021, at 4:30 p.m. ET to discuss its financial results for the quarter ended March 31, 2021, and recent operational highlights. T

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RGNX
Apr 27, 2021
RGNXConferences/Events

REGENXBIO Announces Presentations at the American Society of Gene and Cell Therapy

ROCKVILLE, Md., April 27, 2021 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced that four oral and nine poster presentations will be presented at the American Society of Gene and Cell Therapy's 24th Annual Meeting taking place from May 11 to 14, 2021, in virtual form

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RGNX
Apr 21, 2021
RGNXConferences/Events

REGENXBIO To Present at the Chardan 5th Annual Genetic Medicines Manufacturing Summit

ROCKVILLE, Md., April 21, 2021 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced that Curran M. Simpson, Chief Operations and Technology Officer, will present at the Chardan 5th Annual Genetic Medicines Manufacturing Summit on Tuesday, April 27, 2021 at 3:15 p.m. ET.

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RGNX
Apr 14, 2021
RGNXPhases

REGENXBIO Announces Dosing of First Patient in Cohort 3 of Phase I/II Trial of RGX-121 for the Treatment of MPS II (Hunter Syndrome)

ROCKVILLE, Md., April 14, 2021 /PRNewswire/ -- First patient dosed at third dose level in ongoing trial of RGX-121, a one-time gene therapy for MPS II; total of nine patients have been dosed at four leading clinical centers in the U.S. and Brazil Previously reported positive in

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RGNX
Mar 1, 2021
RGNXPhases

REGENXBIO Reports Fourth Quarter and Full-Year 2020 Financial Results and Operational Highlights Pivotal program for subretinal delivery of RGX-314 for the treatment of wet AMD is active and enrolli

REGENXBIO Reports Fourth Quarter and Full-Year 2020 Financial Results and Operational Highlights ROCKVILLE, Md., March 1, 2021 (GLOBE NEWSWIRE) -- REGENXBIO Inc. (Nasdaq: RGNX) today announced financial results for the fourth quarter and full year ended December 31, 2020, and r

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RGNX
Mar 1, 2021
RGNXGeneral

REGENXBIO Reports Fourth Quarter and Full-Year 2020 Financial Results and Operational Highlights

ROCKVILLE, Md., March 1, 2021 /PRNewswire/ -- Pivotal program for subretinal delivery of RGX-314 for the treatment of wet AMD is active and enrolling patients; expected to support BLA filing in 2024 Phase II trials of RGX-314 utilizing in-office suprachoroidal delivery for trea

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RGNX
Feb 22, 2021
RGNXConferences/Events

REGENXBIO to Host Conference Call on March 1 to Discuss Fourth Quarter and Full-Year 2020 Financial Results and Recent Operational Highlights

ROCKVILLE, Md., Feb. 22, 2021 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced that it will host a conference call on Monday, March 1, 2021, at 4:30 p.m. ET to discuss its financial results for the quarter and full-year ended December 31, 2020, and recent operational

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RGNX
Feb 16, 2021
RGNXPhases

REGENXBIO Announces Additional Positive Interim Phase I/IIa and Long-Term Follow-Up Data of RGX-314 for the Treatment of Wet AMD

ROCKVILLE, Md., Feb. 16, 2021 /PRNewswire/ -- RGX-314 using subretinal delivery continues to be generally well-tolerated at all dose levels Positive interim update from Cohorts 4 and 5 at 1.5 years after RGX-314 administration Durable treatment effect observed with stable visu

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RGNX
Feb 8, 2021
RGNXPhases

REGENXBIO Presents Additional Positive Interim Data from Phase I/II Trial of RGX-121 for the Treatment of MPS II (Hunter Syndrome) at 17th Annual WORLDSymposium™ 2021

ROCKVILLE, Md., Feb. 8, 2021 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced that additional positive interim data from a total of eight patients in Cohorts 1 and 2 of the ongoing Phase I/II trial of RGX-121 for the treatment of patients up to 5 years old diagnosed

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RGNX
Feb 5, 2021
RGNXConferences/Events

REGENXBIO Announces Presentations at the Angiogenesis, Exudation, and Degeneration 2021 Conference

ROCKVILLE, Md., Feb. 5, 2021 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced that two oral presentations will be presented at the Angiogenesis, Exudation, and Degeneration 2021 conference taking place virtually from February 12 to 13, 2021. The presentations will b

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RGNX
Feb 1, 2021
RGNXConferences/Events

REGENXBIO Announces Presentations at the 17th Annual WORLDSymposium™ 2021

ROCKVILLE, Md., Feb. 1, 2021 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced that three oral and nine poster presentations will be presented at the 17th Annual WORLDSymposium™, taking place virtually from February 8 through 12, 2021. The oral presentations include i

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RGNX
Jan 12, 2021
RGNXGeneral

REGENXBIO Announces Closing Of Public Offering Of Common Stock And Full Exercise Of Underwriters

ROCKVILLE, Md., Jan. 12, 2021 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced the closing of its previously announced underwritten public offering of 4,260,000 shares of its common stock at a price to the public of $47.00 per share, as well as the exercise in full o

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RGNX
Jan 11, 2021
RGNXConferences/Events

REGENXBIO to Present at the 39th Annual J.P. Morgan Healthcare Conference

ROCKVILLE, Md., Jan. 11, 2021 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced it will present at the 39th Annual J.P. Morgan Healthcare Conference on Thursday, January 14, 2021 at 11:40 a.m. ET. The conference will be held in a virtual meeting format. A webcast of

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RGNX
Jan 8, 2021
RGNXGeneral

REGENXBIO

REGENXBIO ANNOUNCES PRICING OF PUBLIC OFFERING OF COMMON STOCK ROCKVILLE, Md., January 8, 2021 (PR NEWSWIRE) REGENXBIO Inc. (Nasdaq:RGNX) today announced the pricing of an underwritten public offering of 4,260,000 shares of its common stock at the price of $47.00 per share befo

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RGNX
Jan 8, 2021
RGNXGeneral

REGENXBIO Announces Pricing Of Public Offering Of Common Stock

ROCKVILLE, Md., Jan. 8, 2021 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced the pricing of an underwritten public offering of 4,260,000 shares of its common stock at the price of $47.00 per share before underwriting discounts and commissions. The gross proceeds to

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RGNX
Jan 6, 2021
RGNXGeneral

REGENXBIO Announces Proposed Public Offering Of Common Stock

ROCKVILLE, Md., Jan. 6, 2021 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq:RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, today announced that it intends to

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RGNX
Jan 5, 2021
RGNXPhases

REGENXBIO Announces Update on RGX-314 and Pivotal Program for the Treatment of Wet AMD and New Gene Therapy Program for the Treatment of Duchenne Muscular Dystrophy Pivotal program for RGX-314, potential best-in-class, o

REGENXBIO Announces Update on RGX-314 and Pivotal Program for the Treatment of Wet AMD and New Gene Therapy Program for the Treatment of Duchenne Muscular Dystrophy ROCKVILLE, Md., January 5, 2021 (PRNewswire) REGENXBIO Inc. (Nasdaq: RGNX) today provided an update on the RGX-3

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RGNX
Dec 22, 2020
RGNXPhases

REGENXBIO Announces Agreement to Monetize Portion of Zolgensma Royalties for $200 Million - Agreement with Healthcare Royalty enables REGENXBIO to advance its broad gene therapy pipeline, including pivotal program for RG

REGENXBIO Announces Agreement to Monetize Portion of Zolgensma Royalties for $200 Million - Agreement with Healthcare Royalty enables REGENXBIO to advance its broad gene therapy pipeline, including pivotal program for RGX-314 ROCKVILLE, Md., December 22, 2020 (PRNewswire) REG

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RGNX
Dec 10, 2020
RGNXPhases

REGENXBIO Announces Dosing of First Patient in Phase II ALTITUDE™ Trial of RGX-314 for the Treatment of Diabetic Retinopathy Using Suprachoroidal Delivery

ROCKVILLE, Md., Dec. 10, 2020 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, today announced that the first pa

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RGNX
Dec 9, 2020
RGNXPhases

REGENXBIO Announces Positive Interim Data and Update for Phase I/II Trial of RGX-121 for the Treatment of MPS II

ROCKVILLE, Md., Dec. 9, 2020 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, today announced interim data from

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RGNX
Dec 1, 2020
RGNXPhases

REGENXBIO Announces Dosing of First Patient in Phase I/II Trial of RGX-111 for the Treatment of Mucopolysaccharidosis Type I

ROCKVILLE, Md., Dec. 1, 2020 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, today announced that the first pat

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RGNX
Nov 10, 2020
RGNXConferences/Events

REGENXBIO Announces Presentations at the American Academy of Ophthalmology 2020 Annual Meeting

ROCKVILLE, Md., Nov. 10, 2020 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, today announced that two oral pre

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RGNX
Nov 4, 2020
RGNXPhases

REGENXBIO Reports Third Quarter 2020 Financial Results and Operational Highlights &#x2022; RGX-314 subretinal pivotal wet AMD trial expected to initiate in Q1 2021 &#x2022; Enrollment continues in RGX-314 suprachoroidal

REGENXBIO Reports Third Quarter 2020 Financial Results and Operational Highlights ROCKVILLE, Md., November 4, 2020 (PRNewswire) -- REGENXBIO Inc. (Nasdaq: RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therap

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RGNX
Oct 28, 2020
RGNXConferences/Events

REGENXBIO To Host Conference Call on November 4 to Discuss Third Quarter 2020 Financial Results and Recent Operational Highlights

ROCKVILLE, Md., Oct. 28, 2020 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, today announced that it will host

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RGNX
Oct 27, 2020
RGNXGeneral

REGENXBIO to Receive $80.0 Million Milestone Payment from Novartis AG - Milestone payment based on achievement of $1.0 billion in cumulative net sales of Zolgensma - Zolgensma is the first gene therapy based on REGENXBIO

REGENXBIO to Receive $80.0 Million Milestone Payment from Novartis AG - Milestone payment based on achievement of $1.0 billion in cumulative net sales of Zolgensma - Zolgensma is the first gene therapy based on REGENXBIO s NAV Technology Platform FDA and other regulatory auth

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RGNX
Sep 30, 2020
RGNXGeneral

REGENXBIO Announces Continued Progress and Expansion of Clinical Development Program for RGX-121 for the Treatment of Mucopolysaccharidosis Type II (MPS II)

ROCKVILLE, Md., Sept. 30, 2020 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, today announced the expansion of

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RGNX
Sep 9, 2020
RGNXPhases

REGENXBIO Announces Dosing of First Patient in Phase II AAVIATE™ Trial of RGX-314 for the Treatment of Wet AMD Using Suprachoroidal Delivery

ROCKVILLE, Md., Sept. 9, 2020 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, today announced that the first pa

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RGNX
Aug 25, 2020
RGNXFDA Updates

REGENXBIO Announces FDA Clearance of IND for Phase II Trial of RGX-314 for the Treatment of Diabetic Retinopathy Using Suprachoroidal Delivery

ROCKVILLE, Md., Aug. 25, 2020 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, today announced the clearance of

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RGNX
Aug 6, 2020
RGNXPhases

REGENXBIO Reports Second Quarter 2020 Financial Results and Operational Highlights &#x2022; RGX-314 subretinal delivery pivotal program for wet AMD to initiate by end of 2020; positive interim updat

REGENXBIO Reports Second Quarter 2020 Financial Results and Operational Highlights ROCKVILLE, Md., August 6, 2020 (PRNewswire) -- REGENXBIO Inc. (Nasdaq: RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy

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RGNX
Aug 6, 2020
RGNXGeneral

REGENXBIO Reports Second Quarter 2020 Financial Results and Operational Highlights

ROCKVILLE, Md., Aug. 6, 2020 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, today announced financial results

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RGNX
Aug 4, 2020
RGNXPhases

REGENXBIO Announces Additional Positive Interim Phase I/IIa Trial Update and Program Updates for RGX-314 for the Treatment of Wet AMD

ROCKVILLE, Md., Aug. 4, 2020 /PRNewswire/ -- Company on track to initiate RGX-314 subretinal delivery pivotal program by the end of 2020 RGX-314 was generally well-tolerated in 42 patients at all dose levels in Phase I/IIa trial Positive interim update from Cohorts 4 and 5 at

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RGNX
Jul 30, 2020
RGNXConferences/Events

REGENXBIO To Host Conference Call on August 6 to Discuss Second Quarter 2020 Financial Results and Recent Operational Highlights

ROCKVILLE, Md., July 30, 2020 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, today announced that it will host

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RGNX
Jul 8, 2020
RGNXGeneral

REGENXBIO Provides Update on Progress of Clinical Programs for Rare Genetic Neurodegenerative Diseases

ROCKVILLE, Md., July 8, 2020 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, today announced that it has comple

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RGNX
Jun 10, 2020
RGNXConferences/Events

REGENXBIO to Present at the Raymond James Human Health Innovation Conference

ROCKVILLE, Md., June 10, 2020 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq:RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, today announced it will present at

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RGNX
May 7, 2020
RGNXGeneral

REGENXBIO Reports First Quarter 2020 Financial Results and Operational Highlights

ROCKVILLE, Md., May 7, 2020 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, today announced financial results f

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RGNX
May 7, 2020
RGNXPhases

REGENXBIO Reports First Quarter 2020 Financial Results and Operational Highlights &#x2022; Positive long-term and interim data update from RGX-314 Phase I/IIa trial for wet AMD recently announced &#

REGENXBIO Reports First Quarter 2020 Financial Results and Operational Highlights ROCKVILLE, Md., May 7, 2020 (PRNewswire) -- REGENXBIO Inc. (Nasdaq: RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy bas

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RGNX
Apr 30, 2020
RGNXConferences/Events

REGENXBIO To Host Conference Call on May 7 to Discuss First Quarter 2020 Financial Results and Recent Operational Highlights

ROCKVILLE, Md., April 30, 2020 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, today announced that it will hos

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RGNX
Apr 22, 2020
RGNXPhases

REGENXBIO Announces Additional Positive Long-term and Interim Phase I/IIa Trial Update for RGX-314 for the Treatment of Wet AMD

ROCKVILLE, Md., April 22, 2020 /PRNewswire/ -- RGX-314 continues to be well-tolerated at all dose levels Long-term, durable treatment effect demonstrated over two years in Cohort 3 Mean improvement in vision (+14 letters) and stable retinal thickness (+2 µm) 50% of patients (

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RGNX
Mar 31, 2020
RGNXGeneral

REGENXBIO and Ultragenyx Announce New License Agreement for Use of NAV® Technology Platform for the Treatment of Rare Metabolic Disorder

(PRNewsfoto/REGENXBIO Inc.) (PRNewsfoto/REGENXBIO Inc.) ROCKVILLE, Md. and NOVATO, Calif., March 31, 2020 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq:RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based o

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RGNX
Mar 9, 2020
RGNXConferences/Events

REGENXBIO to Present at the Barclays Global Healthcare Conference

ROCKVILLE, Md., March 9, 2020 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV Technology Platform, today announced it will present an

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RGNX
Feb 26, 2020
RGNXGeneral

REGENXBIO Reports Fourth Quarter and Full-Year 2019 Financial Results and Operational Highlights

ROCKVILLE, Md., Feb. 26, 2020 /PRNewswire/ -- Additional data from RGX-314 Phase I/IIa trial for wet AMD expected in 1H 2020 RGX-314 clinical trials for treatment of wet AMD and diabetic retinopathy expected to advance in 2020 using subretinal and suprachoroidal delivery approa

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RGNX
Feb 26, 2020
RGNXPhases

REGENXBIO Reports Fourth Quarter and Full-Year 2019 Financial Results and Operational Highlights &#x2022; Additional data from RGX-314 Phase I/IIa trial for wet AMD expected in 1H 2020 &#x2022; RGX-

REGENXBIO Reports Fourth Quarter and Full-Year 2019 Financial Results and Operational Highlights ROCKVILLE, Md., Feb. 26, 2020 (GLOBE NEWSWIRE) -- REGENXBIO Inc. (Nasdaq: RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potenti

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RGNX
Feb 19, 2020
RGNXConferences/Events

REGENXBIO To Host Conference Call on February 26 to Discuss Fourth Quarter and Full-Year 2019 Financial Results and Recent Operational Highlights

ROCKVILLE, Md., Feb. 19, 2020 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, today announced that it will host

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RGNX
Jan 29, 2020
RGNXConferences/Events

REGENXBIO Announces Presentations at the 16th Annual WORLDSymposium™ 2020

ROCKVILLE, Md., Jan. 29, 2020 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, today announced several poster pr

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RGNX
Jan 9, 2020
RGNXPhases

REGENXBIO Reports Continued Progress Across Programs in Year-End 2019 Corporate Update RGX-314 programs for treatment of wet AMD and diabetic retinopathy continue to advance Plans to initiate a pivotal program of subreti

REGENXBIO Reports Continued Progress Across Programs in Year-End 2019 Corporate Update ROCKVILLE, Md., Jan. 9, 2020 (GLOBE NEWSWIRE) REGENXBIO Inc. (Nasdaq: RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene th

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RGNX
Dec 18, 2019
RGNXPhases

REGENXBIO Announces Interim Data from Phase I/II Trial of RGX-121 for the Treatment of Mucopolysaccharidosis Type II (MPS II)

ROCKVILLE, Md., Dec. 18, 2019 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, today announced interim data from

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RGNX
Nov 26, 2019
RGNXConferences/Events

REGENXBIO to Present at the Evercore ISI 2nd Annual HealthCONx Conference

ROCKVILLE, Md., Nov. 26, 2019 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, today announced it will present a

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RGNX
Nov 5, 2019
RGNXPhases

REGENXBIO Reports Third Quarter 2019 Financial and Operating Results and Recent Operational Highlights &#x2022; Initiation of RGX-314 Phase IIb trial for wet AMD and IND filing for Phase II trial in

REGENXBIO Reports Third Quarter 2019 Financial and Operating Results and Recent Operational Highlights ROCKVILLE, Md., November 5, 2019 (PRNewswire) -- REGENXBIO Inc. (Nasdaq: RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative pot

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RGNX
Nov 5, 2019
RGNXGeneral

REGENXBIO Reports Third Quarter 2019 Financial and Operating Results and Recent Operational Highlights

ROCKVILLE, Md., Nov. 5, 2019 /PRNewswire/ -- Initiation of RGX-314 Phase IIb trial for wet AMD and IND filing for Phase II trial in diabetic retinopathy now expected in Q1 2020 as a result of partial clinical hold following FDA notification related to certain commercial, third-p

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RGNX
Oct 29, 2019
RGNXConferences/Events

REGENXBIO To Host Conference Call on November 5 to Discuss Third Quarter 2019 Financial Results and Recent Operational Highlights

ROCKVILLE, Md., Oct. 29, 2019 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, today announced that it will host

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RGNX
Oct 17, 2019
RGNXConferences/Events

REGENXBIO Announces Presentations at the European Society of Gene & Cell Therapy 27th Annual Congress

ROCKVILLE, Md., Oct. 17, 2019 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, today announced the presentation

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RGNX
Oct 11, 2019
RGNXPhases

REGENXBIO Announces Additional Positive Interim Phase I/IIa Trial Update for RGX-314 for the Treatment of Wet AMD at the American Academy of Ophthalmology 2019 Annual Meeting

ROCKVILLE, Md., Oct. 11, 2019 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, today announced interim data from

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RGNX
Oct 9, 2019
RGNXPhases

Key Takeaways from the RGX-314 Phase I/IIa Clinical Trial for Wet AMD (Cohorts 1-5) Jeffrey Heier, MD Peter Campochiaro, MD, Allen Ho, MD, Albert Maguire, MD, David M. Brown, MD, Robert Avery, MD, Dante Pieramici, MD, Sz

for Wet AMD (Cohorts 1-5) Jeffrey Heier, MD Peter Campochiaro, MD, Allen Ho, MD, Albert Maguire, MD, David M. Brown, MD, Robert Avery, MD, Dante Pieramici, MD, Szilard Kiss, MD, Arshad Khanani, MD, Charles Wykoff, MD Samir Patel, MD, Keunpyo Kim, PhD, Darin Curtiss, PharmD, Step

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RGNX
Sep 30, 2019
RGNXConferences/Events

REGENXBIO to Present at The Chardan 3rd Annual Genetic Medicines Conference

ROCKVILLE, Md., Sept. 30, 2019 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq:RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, today announced that it will pres

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RGNX
Aug 27, 2019
RGNXPhases

REGENXBIO to Present Interim Phase I/IIa Trial Update for RGX-314 for the Treatment of Wet AMD at the American Academy of Ophthalmology 2019 Annual Meeting in October

ROCKVILLE, Md., Aug. 27, 2019 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, today announced that an interim t

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RGNX
Aug 7, 2019
RGNXPhases

REGENXBIO Reports Second Quarter 2019 Financial and Operating Results and Additional Positive Interim Phase I/IIa Trial Update for RGX-314 for the Treatment of Wet AMD &#x2022; Reports further posit

REGENXBIO Reports Second Quarter 2019 Financial and Operating Results and Additional Positive Interim Phase I/IIa Trial Update for RGX-314 for the Treatment of Wet AMD ROCKVILLE, Md., August 7, 2019 (PRNewswire) -- REGENXBIO Inc. (Nasdaq: RGNX), a leading clinical-stage biotechn

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RGNX
Aug 7, 2019
RGNXPhases

REGENXBIO Reports Second Quarter 2019 Financial and Operating Results and Additional Positive Interim Phase I/IIa Trial Update for RGX-314 for the Treatment of Wet AMD

ROCKVILLE, Md., Aug. 7, 2019 /PRNewswire/ -- Reports further positive interim update from RGX-314 Phase I/IIa trial for Wet AMD Well-tolerated at all doses Dose-dependent protein expression levels observed across all five dose cohorts 50% of subjects treated in Cohort 3 remai

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RGNX
Jul 31, 2019
RGNXGeneral

REGENXBIO Announces New License Agreement with Pfizer for the Treatment of Friedreich

ROCKVILLE, Md., July 31, 2019 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV Technology Platform, today announced it entered into a

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RGNX
Jul 30, 2019
RGNXConferences/Events

REGENXBIO To Host Conference Call on August 7 to Discuss Second Quarter 2019 Financial Results and Recent Operational Highlights

ROCKVILLE, Md., July 30, 2019 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, today announced that it will host

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RGNX
Jul 24, 2019
RGNXGeneral

REGENXBIO and Neurimmune Announce Collaboration to Develop Vectorized Antibodies for the Treatment of Neurodegenerative Diseases

ROCKVILLE, Md. and ZURICH, July 24, 2019 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform and Neurimmune AG, a le

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RGNX
Jul 24, 2019
RGNXGeneral

REGENXBIO Expands Pipeline Using NAV Vectors to Deliver Therapeutic Antibodies for the Treatment of Hereditary Angioedema and Neurodegenerative Diseases

ROCKVILLE, Md., July 24, 2019 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, today announced an expansion of i

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RGNX
Jun 11, 2019
RGNXConferences/Events

REGENXBIO to Present at the Raymond James 2019 Life Sciences and MedTech Conference

ROCKVILLE, Md., June 11, 2019 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, today announced it will present a

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RGNX
May 30, 2019
RGNXPhases

REGENXBIO Announces Completion of Dosing for Phase I/IIa Clinical Trial of RGX-314 in Wet AMD

ROCKVILLE, Md., May 30, 2019 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, today announced it completed dosin

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RGNX
May 24, 2019
RGNXFDA Updates

REGENXBIO Announces First FDA Approval of a Gene Therapy Based on Its Proprietary NAV® Technology Platform

ROCKVILLE, Md., May 24, 2019 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, today announced the first U.S. Foo

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RGNX
May 15, 2019
RGNXGeneral

REGENXBIO to Launch New Manufacturing Facility for NAV Technology-based AAV Gene Therapies

ROCKVILLE, Md., May 15, 2019 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, today announced its plan to constr

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RGNX
May 8, 2019
RGNXConferences/Events

REGENXBIO to Present at the Bank of America Merrill Lynch 2019 Healthcare Conference

ROCKVILLE, Md., May 8, 2019 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, today announced it will present at

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RGNX
May 7, 2019
RGNXPhases

REGENXBIO Reports First Quarter 2019 Financial and Operating Results and Additional Positive Interim Phase I/IIa Trial Update for RGX-314 for the Treatment of Wet AMD &#x2022; Reports positive inter

REGENXBIO Reports First Quarter 2019 Financial and Operating Results and Additional Positive Interim Phase I/IIa Trial Update for RGX-314 for the Treatment of Wet AMD ROCKVILLE, Md., May 7, 2019 (PRNewswire) -- REGENXBIO Inc. (Nasdaq: RGNX), a leading clinical-stage biotechnolog

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RGNX
May 7, 2019
RGNXPhases

REGENXBIO Reports First Quarter 2019 Financial and Operating Results and Additional Positive Interim Phase I/IIa Trial Update for RGX-314 for the Treatment of Wet AMD

ROCKVILLE, Md., May 7, 2019 /PRNewswire/ -- Reports positive interim update from RGX-314 Phase I/IIa trial for wet AMD in Cohort 3 over one year Announces new IND submission for RGX-314 for a Phase II trial in diabetic retinopathy; filing planned for second half 2019 Continuin

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RGNX
Apr 30, 2019
RGNXConferences/Events

REGENXBIO to Host Conference Call on May 7 to Discuss First Quarter 2019 Financial Results and Recent Operational Highlights

ROCKVILLE, Md., April 30, 2019 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, today announced that it will hos

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RGNX
Apr 17, 2019
RGNXGeneral

REGENXBIO Appoints Dr. Steve Pakola as Chief Medical Officer

ROCKVILLE, Md., April 17, 2019 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, today announced the appointment

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RGNX
Apr 15, 2019
RGNXConferences/Events

REGENXBIO Announces Presentations at the American Society of Gene & Cell Therapy 2019 Annual Meeting

ROCKVILLE, Md., April 15, 2019 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, today announced the presentation

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RGNX
Feb 27, 2019
RGNXGeneral

REGENXBIO Reports Fourth Quarter and Full-Year 2018 Financial Results and Recent Operational Highlights

ROCKVILLE, Md., Feb. 27, 2019 /PRNewswire/ -- Announces updates from recently expanded RGX-314 Phase I/IIa trial for wet AMD Completed dosing of six additional subjects in the fourth cohort for a total of 12 subjects; 30 subjects dosed across four cohorts in the trial On-track

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RGNX
Feb 21, 2019
RGNXPhases

REGENXBIO Reports Fourth Quarter and Full-Year 2018 Financial Results and Recent Operational Highlights &#x2022; Announces updates from recently expanded RGX-314 Phase I/IIa trial for wet AMD o Comp

REGENXBIO Reports Fourth Quarter and Full-Year 2018 Financial Results and Recent Operational Highlights ROCKVILLE, Md., Feb. 27, 2019 (GLOBE NEWSWIRE) -- REGENXBIO Inc. (Nasdaq:RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative p

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RGNX
Feb 20, 2019
RGNXConferences/Events

REGENXBIO to Host Conference Call on February 27 to Discuss Fourth Quarter and Full-Year 2018 Financial Results and Recent Operational Highlights

ROCKVILLE, Md., Feb. 20, 2019 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, today announced that it will host

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RGNX
Feb 14, 2019
RGNXGeneral

REGENXBIO to Host RGX-314 Program Analyst and Investor Event with Leading Retina Specialists

ROCKVILLE, Md., Feb. 14, 2019 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq:RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, will host an analyst and investor

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RGNX
Jan 31, 2019
RGNXGeneral

REGENXBIO Receives Rare Pediatric Disease Designation for RGX-181 Gene Therapy for the Treatment of CLN2 Form of Batten Disease

ROCKVILLE, Md., Jan. 31, 2019 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, today announced the U.S. Food and

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RGNX
Jan 4, 2019
RGNXConferences/Events

REGENXBIO to Present at the 37th Annual J.P. Morgan Healthcare Conference

ROCKVILLE, Md., Jan. 4, 2019 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, today announced that it will prese

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RGNX
Jan 3, 2019
RGNXGeneral

REGENXBIO Reports Continued Progress Across Programs in Year-End 2018 Corporate Update

ROCKVILLE, Md., Jan. 3, 2019 /PRNewswire/ -- Reports further positive interim update from RGX-314 Phase I trial for wet AMD: 50% of subjects treated in Cohort 3 continue to remain free of anti-VEGF injections at nine months Mean RGX-314 intraocular protein expression in recent

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RGNX
Dec 31, 2018
RGNXPhases

REGENXBIO Reports Continued Progress Across Programs in Year-End 2018 Corporate Update Reports further positive interim update from RGX-314 Phase I trial for wet AMD: 50% of subjects treated in Cohort 3 continue to remai

REGENXBIO Reports Continued Progress Across Programs in Year-End 2018 Corporate Update ROCKVILLE, Md., Jan. 03, 2019 (GLOBE NEWSWIRE) REGENXBIO Inc. (Nasdaq:RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene th

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RGNX
Nov 26, 2018
RGNXGeneral

REGENXBIO and Rocket Pharmaceuticals Announce New License Agreement for the Treatment of Danon Disease Using NAV AAV9 Vector

ROCKVILLE, Md. and NEW YORK, Nov. 26, 2018 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, and Rocket Pharmaceu

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RGNX
Nov 14, 2018
RGNXFDA Updates

FDA Grants Orphan Drug Designation To RGX-181 Gene Therapy For The Treatment Of CLN2 Form Of Batten Disease

ROCKVILLE, Md., Nov. 14, 2018 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, today announced the U.S. Food and

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RGNX
Nov 7, 2018
RGNXPhases

REGENXBIO Reports Third Quarter 2018 Financial and Operating Results and Announces Initiation of Phase I/II Clinical Trial for RGX-121 for the Treatment of MPS II &#x2022; Announces first subject dosed in RGX-121 Phase I

REGENXBIO Reports Third Quarter 2018 Financial and Operating Results and Announces Initiation of Phase I/II Clinical Trial for RGX-121 for the Treatment of MPS II ROCKVILLE, Md., November 7, 2018 (PRNewswire) -- REGENXBIO Inc. (Nasdaq:RGNX), a leading clinical-stage biotechnolog

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RGNX
Nov 5, 2018
RGNXGeneral

REGENXBIO and Abeona Therapeutics Announce Worldwide Exclusive Licenses for the Treatment of Four Rare Lysosomal Storage Disorders Using NAV AAV9 Vector REGENXBIO grants Abeona new licenses to NAV AAV9 for the developmen

REGENXBIO and Abeona Therapeutics Announce Worldwide Exclusive Licenses for the Treatment of Four Rare Lysosomal Storage Disorders Using NAV AAV9 Vector ROCKVILLE, Md., Nov. 5, 2018 (PRNEWSWIRE) REGENXBIO Inc. (Nasdaq:RGNX), a leading clinical-stage biotechnology company seeki

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RGNX
Oct 31, 2018
RGNXConferences/Events

REGENXBIO to Host Conference Call on November 7 to Discuss Third Quarter 2018 Financial Results and Recent Operational Highlights

ROCKVILLE, Md., Oct. 31, 2018 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, today announced that it will host

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RGNX
Oct 26, 2018
RGNXPhases

REGENXBIO Announces Additional Positive Interim Phase I Trial Update for RGX-314 for the Treatment of Wet AMD at the American Academy of Ophthalmology 2018 Annual Meeting

ROCKVILLE, Md., Oct. 26, 2018 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, today announced updated results f

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RGNX
Oct 22, 2018
RGNXGeneral

REGENXBIO Announces Exclusive Worldwide License with Ultragenyx for the Treatment of CDKL5 Deficiency Disorder Using NAV Vectors

ROCKVILLE, Md., Oct. 22, 2018 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, today announced that Ultragenyx P

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RGNX
Oct 4, 2018
RGNXPhases

REGENXBIO Announces Completion of Dosing of Fourth Cohort in Phase I Clinical Trial of RGX-314 Gene Therapy for Wet AMD

ROCKVILLE, Md., Oct. 4, 2018 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, today announced it has completed d

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RGNX
Oct 2, 2018
RGNXConferences/Events

REGENXBIO to Present at the Chardan 2nd Annual Genetic Medicines Conference

ROCKVILLE, Md., Oct. 2, 2018 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, today announced that it will prese

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RGNX
Aug 30, 2018
RGNXGeneral

REGENXBIO Announces Pipeline Expansion with RGX-181 Gene Therapy for CLN2 Form of Batten Disease

ROCKVILLE, Md., Aug. 30, 2018 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, today announced it is developing

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RGNX
Aug 14, 2018
RGNXGeneral

REGENXBIO Announces Closing of Public Offering of Common Stock and Full Exercise of Underwriters

ROCKVILLE, Md., Aug. 14, 2018 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, today announced the closing of it

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RGNX
Aug 8, 2018
RGNXPhases

REGENXBIO Reports Second Quarter 2018 Financial and Operating Results and Interim Data from Ongoing Clinical Trials for Wet Age-Related Macular Degeneration and Homozygous Familial Hypercholesterolemia &#x2022; Announces

REGENXBIO Reports Second Quarter 2018 Financial and Operating Results and Interim Data from Ongoing Clinical Trials for Wet Age-Related Macular Degeneration and Homozygous Familial Hypercholesterolemia ROCKVILLE, Md., August 8, 2018 (PRNewswire) -- REGENXBIO Inc. (Nasdaq:RGNX),

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RGNX
Aug 7, 2018
RGNXPhases

REGENXBIO to Host Conference Call and Webcast on August 8 to Discuss Second Quarter 2018 Financial and Operating Results and Interim Data from Ongoing Clinical Trials for Wet Age-Related Macular Degeneration and Homozygous Familial Hypercholesterolemia

ROCKVILLE, Md., Aug. 7, 2018 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, today announced that its previousl

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RGNX
Aug 1, 2018
RGNXConferences/Events

REGENXBIO to Host Conference Call on August 8 to Discuss Second Quarter 2018 Financial Results and Recent Operational Highlights

ROCKVILLE, Md., Aug. 1, 2018 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, today announced that it will host

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RGNX
Jun 12, 2018
RGNXFDA Updates

REGENXBIO Receives FDA Fast Track Designation for RGX-111 Gene Therapy for the Treatment of Mucopolysaccharidosis Type I

ROCKVILLE, Md., June 12, 2018 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, today announced that the U.S. Foo

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RGNX
Jun 11, 2018
RGNXGeneral

REGENXBIO Receives $100 Million Accelerated License Payment Due to Acquisition of AveXis by Novartis $100 million license payment consists of annual fees and a commercial milestone fee accelerated upon the change of cont

REGENXBIO Receives $100 Million Accelerated License Payment Due to Acquisition of AveXis by Novartis ROCKVILLE, Md., June 11, 2018 (PRNewswire) REGENXBIO Inc. (Nasdaq:RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential o

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RGNX
May 29, 2018
RGNXGeneral

Alexandra Glucksmann Joins REGENXBIO Board of Directors Dr. Glucksmann brings 25 years of R&D leadership and operations expertise to the role ROCKVILLE, Md.

Alexandra Glucksmann Joins REGENXBIO Board of Directors Dr. Glucksmann brings 25 years of R&D leadership and operations expertise to the role ROCKVILLE, Md., May 29, 2018 (PRNewswire) REGENXBIO Inc. (Nasdaq:RGNX), a leading clinical-stage biotechnology company seeking to improv

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RGNX
May 15, 2018
RGNXGeneral

REGENXBIO Joins the Mucopolysaccharidosis Community to Advance Research and Innovation

ROCKVILLE, Md., May 15, 2018 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, today recognizes International Muc

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RGNX
May 9, 2018
RGNXConferences/Events

REGENXBIO to Present at the Bank of America Merrill Lynch 2018 Healthcare Conference

ROCKVILLE, Md., May 9, 2018 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, today announced that it will presen

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RGNX
May 8, 2018
RGNXPhases

REGENXBIO Reports First Quarter 2018 Financial Results and Recent Operational Highlights &#x2022; Completed dosing of third cohort in RGX-314 Phase I clinical trial for wet AMD &#x2022; Completed dosing of third patient

REGENXBIO Reports First Quarter 2018 Financial Results and Recent Operational Highlights ROCKVILLE, Md., May 8, 2018 (PRNewswire) -- REGENXBIO Inc. (Nasdaq:RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene thera

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RGNX
May 2, 2018
RGNXFDA Updates

REGENXBIO Receives FDA Fast Track Designation for RGX-121 Gene Therapy for the Treatment of Mucopolysaccharidosis Type II

ROCKVILLE, Md., May 2, 2018 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, today announced that the U.S. Food

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RGNX
May 1, 2018
RGNXConferences/Events

REGENXBIO to Host Conference Call on May 8 to Discuss First Quarter 2018 Financial Results and Recent Operational Highlights

ROCKVILLE, Md., May 1, 2018 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, today announced that it will host a

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RGNX
Mar 6, 2018
RGNXPhases

REGENXBIO Reports Fourth Quarter and Full-Year 2017 Financial Results and Recent Operational Highlights &#x2022; Completed dosing of third cohort in RGX-314 Phase I clinical trial for wet AMD &#x2022; Continuing dosing o

REGENXBIO Reports Fourth Quarter and Full-Year 2017 Financial Results and Recent Operational Highlights ROCKVILLE, Md., March 6, 2018 (GLOBE NEWSWIRE) -- REGENXBIO Inc. (Nasdaq:RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative po

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RGNX
Feb 27, 2018
RGNXConferences/Events

REGENXBIO to Host Conference Call on March 6 to Discuss Fourth Quarter and Full-Year 2017 Financial Results and Recent Operational Highlights

ROCKVILLE, Md., Feb. 27, 2018 (GLOBE NEWSWIRE) -- REGENXBIO Inc. (Nasdaq:RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, today announced that it will h

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RGNX
Feb 8, 2018
RGNXPhases

REGENXBIO Announces Completion of Dosing of Third Cohort in Phase I Clinical Trial of RGX-314 Gene Therapy for Wet AMD

REGENXBIO has completed dosing of the third cohort in its Phase I clinical trial for RGX-314, aimed at treating wet AMD. This trial involves six retinal surgery centers across the U.S. and is designed to assess the safety and tolerability of RGX-314. The company plans to share topline results later in 2018.

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RGNX
Jan 23, 2018
RGNXGeneral

REGENXBIO Enhances Gene Therapy Manufacturing Capabilities by Entering into Strategic Partnership with FUJIFILM Diosynth Biotechnologies

REGENXBIO has partnered with FUJIFILM Diosynth Biotechnologies to enhance its gene therapy manufacturing capabilities. This agreement allows REGENXBIO to produce its lead product candidates at a larger scale of up to 2,000L, supporting their late-stage clinical development and early commercialization. The partnership builds on REGENXBIO's existing internal capabilities and ensures compliance with global regulatory standards.

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RGNX
Jan 8, 2018
RGNXGeneral

REGENXBIO and AveXis Announce Expansion of Relationship through Amended License Agreement for the Development and Commercialization of Treatments for Spinal Muscular Atrophy

REGENXBIO and AveXis have amended their license agreement to expand collaboration on gene therapies for spinal muscular atrophy (SMA). The amendment grants AveXis exclusive rights to REGENXBIO's NAV Technology Platform for SMA treatments. REGENXBIO will receive an upfront payment of $80 million, along with additional payments and potential royalties on net sales.

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RGNX
Jan 4, 2018
RGNXGeneral

REGENXBIO Provides Year-End 2017 Corporate Update

REGENXBIO provided a corporate update for year-end 2017, highlighting the initiation of new clinical trial cohorts for RGX-314 and RGX-501. The company anticipates completing dosing and presenting topline data from these trials in late 2018. Additionally, REGENXBIO reported a strong financial position with over $175 million in cash and plans to expand its research capabilities.

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RGNX
Jan 4, 2018
RGNXPhases

REGENXBIO Provides Year-End 2017 Corporate Update - Initiated third cohort dosing of RGX-314 Phase I clinical trial for wet AMD - - Initiated second cohort dosing of RGX-501 Phase I/II clinical trial for HoFH - - Anticip

REGENXBIO Provides Year-End 2017 Corporate Update - Initiated third cohort dosing of RGX-314 Phase I clinical trial for wet AMD - - Initiated second cohort dosing of RGX-501 Phase I/II clinical trial for HoFH - - Anticipate completing dosing and presenting topline data from RG

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RGNX
Dec 19, 2017
RGNXPhases

REGENXBIO Announces IND Active for Phase I/II Trial of RGX-121 to Treat Mucopolysaccharidosis Type II

REGENXBIO has announced that the Investigational New Drug application for RGX-121 is active, allowing the initiation of a Phase I/II trial to treat pediatric patients with Mucopolysaccharidosis Type II (MPS II). The trial aims to evaluate the safety and tolerability of RGX-121, a gene therapy designed to address neurocognitive decline associated with the disease. Enrollment is expected to begin in the first half of 2018, with participation from leading gene therapy centers.

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RGNX
Nov 8, 2017
RGNXPhases

REGENXBIO Reports Third Quarter 2017 Financial Results and Recent Operational Highlights &#x2022; Completed second cohort dosing in RGX-314 Phase I clinical trial for wet AMD &#x2022; Completed first cohort dosing in RGX

REGENXBIO Reports Third Quarter 2017 Financial Results and Recent Operational Highlights ROCKVILLE, Md., November 8, 2017 (GLOBE NEWSWIRE) -- REGENXBIO Inc. (Nasdaq:RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of g

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RGNX
Nov 1, 2017
RGNXConferences/Events

REGENXBIO to Host Conference Call on November 8 to Discuss Third Quarter 2017 Financial Results and Recent Operational Highlights

ROCKVILLE, Md., Nov. 01, 2017 (GLOBE NEWSWIRE) -- REGENXBIO Inc. (Nasdaq:RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, today announced that it will h

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RGNX
Oct 2, 2017
RGNXGeneral

REGENXBIO RESPONDS TO NOTIFICATION OF A SUPERIOR PROPOSAL UNDER ITS MERGER AGREEMENT WITH DIMENSION THERAPEUTICS Company Focused on Advancing Proprietary NAV Technology Platform and Deep Gene Therapy Treatment Pipeline R

REGENXBIO RESPONDS TO NOTIFICATION OF A SUPERIOR PROPOSAL UNDER ITS MERGER AGREEMENT WITH DIMENSION THERAPEUTICS Company Focused on Advancing Proprietary NAV Technology Platform and Deep Gene Therapy Treatment Pipeline ROCKVILLE, MD. October 2, 2017 REGENXBIO Inc. (Nasdaq:RGN

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RGNX
Sep 20, 2017
RGNXPhases

REGENXBIO Announces Completion of Dosing of First Cohort in Phase I Clinical Trial of RGX-314 Gene Therapy for Wet AMD

Six patients dosed at leading retinal surgery centers in the United States All participating study centers now active; next dose cohort is projected to start after review by the Data Safety Monitoring Board this month Clinical trial evaluates one-time treatment for wet AMD usin

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RGNX
Aug 25, 2017
RGNXPhases

REGENXBIO to Acquire Dimension Therapeutics Acquisition will add two lead product candidates to REGENXBIO s metabolic disease franchise: DTX301 for OTC deficiency, being studied in an on-going Phase I/II clinical trial D

REGENXBIO to Acquire Dimension Therapeutics ROCKVILLE, Md., and CAMBRIDGE, Mass., Aug. 25, 2017 REGENXBIO Inc. (Nasdaq:RGNX) and Dimension Therapeutics, Inc. (Nasdaq:DMTX) today announced that they have entered into a definitive agreement under which REGENXBIO will acquire Dime

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RGNX
Aug 25, 2017
RGNXGeneral

REGENXBIO to Acquire Dimension Therapeutics

Acquisition will add two lead product candidates to REGENXBIO’s metabolic disease franchise: - DTX301 for OTC deficiency, being studied in an on-going Phase I/II clinical trial - DTX401 for GSDIa, a late-stage preclinical candidate with an anticipated IND filing in early 2018

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RGNX
Aug 11, 2017
RGNXConferences/Events

REGENXBIO to Present on RGX-314 Gene Therapy Program for Wet AMD at 35th Annual Scientific Meeting of the American Society of Retina Specialists

RGX-314 trial design and subretinal delivery overview to be presented Enrollment continues in RGX-314 Phase I clinical trial for wet AMD; interim update anticipated by year-end 2017 ROCKVILLE, Md., Aug. 11, 2017 (GLOBE NEWSWIRE) -- REGENXBIO Inc. (Nasdaq:RGNX), a leading clinic

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RGNX
Aug 8, 2017
RGNXPhases

REGENXBIO Reports Second Quarter 2017 Financial Results and Recent Operational Highlights &#x2022; Enrollment continues in RGX-314 Phase I clinical trial for wet AMD; interim update anticipated by year-end 2017 &#x2022;

REGENXBIO Reports Second Quarter 2017 Financial Results and Recent Operational Highlights ROCKVILLE, Md., August 8, 2017 (GLOBE NEWSWIRE) -- REGENXBIO Inc. (Nasdaq:RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of ge

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RGNX
Aug 1, 2017
RGNXConferences/Events

REGENXBIO to Host Conference Call on August 8 to Discuss Second Quarter 2017 Financial Results and Recent Operational Highlights

ROCKVILLE, Md., Aug. 01, 2017 (GLOBE NEWSWIRE) -- REGENXBIO Inc. (Nasdaq:RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, today announced that it will h

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RGNX
Jul 6, 2017
RGNXConferences/Events

REGENXBIO to Participate in the Piper Jaffray GenomeRx Symposium

ROCKVILLE, Md., July 06, 2017 (GLOBE NEWSWIRE) -- REGENXBIO Inc. (Nasdaq:RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, today announced that it will p

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RGNX
Jun 7, 2017
RGNXGeneral

REGENXBIO and AveXis Announce New Exclusive Worldwide Licenses for the Treatment of Two Rare Neurological Monogenic Disorders Using NAV AAV9 Vector

ROCKVILLE, Md. and CHICAGO, Ill., June 07, 2017 (GLOBE NEWSWIRE) -- REGENXBIO Inc. (NASDAQ:RGNX) and AveXis, Inc. (NASDAQ:AVXS) today announced an exclusive worldwide license agreement for AveXis to develop and commercialize gene therapy treatments using REGENXBIO’s NAV AAV9 vect

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RGNX
May 31, 2017
RGNXPhases

REGENXBIO Announces Initiation of Phase I Clinical Trial of RGX-314 Gene Therapy for Wet Age-Related Macular Degeneration

Clinical trial evaluates one-time treatment for wet AMD using NAV® AAV8 gene therapy; interim trial update expected late 2017 ROCKVILLE, Md., May 31, 2017 (GLOBE NEWSWIRE) -- REGENXBIO Inc. (Nasdaq:RGNX), a leading clinical-stage biotechnology company seeking to improve lives th

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RGNX
May 10, 2017
RGNXConferences/Events

REGENXBIO to Present at the Bank of America Merrill Lynch 2017 Health Care Conference

ROCKVILLE, Md., May 10, 2017 (GLOBE NEWSWIRE) -- REGENXBIO Inc. (Nasdaq:RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, today announced that it will pa

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RGNX
May 9, 2017
RGNXPhases

REGENXBIO Reports First Quarter 2017 Financial Results and Recent Operational Highlights &#x2022; On track to initiate dosing of patients in RGX-314 Phase I trial for wet AMD by mid-2017 and continuing enrollment of pati

REGENXBIO Reports First Quarter 2017 Financial Results and Recent Operational Highlights ROCKVILLE, Md., May 9, 2017 (GLOBE NEWSWIRE) -- REGENXBIO Inc. (Nasdaq:RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene t

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RGNX
May 2, 2017
RGNXConferences/Events

REGENXBIO to Host Conference Call on May 9 to Discuss First Quarter 2017 Financial Results and Recent Operational Highlights

ROCKVILLE, Md., May 02, 2017 (GLOBE NEWSWIRE) -- REGENXBIO Inc. (Nasdaq:RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, today announced that it will ho

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RGNX
Apr 26, 2017
RGNXGeneral

REGENXBIO Announces Full Exercise and Closing of Underwriters Option to Purchase Additional Shares ROCKVILLE, Md.

REGENXBIO Announces Full Exercise and Closing of Underwriters Option to Purchase Additional Shares ROCKVILLE, Md., April 26, 2017 REGENXBIO Inc. (Nasdaq:RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy

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RGNX
Mar 28, 2017
RGNXGeneral

REGENXBIO Enhances and Expands Scientific Leadership

ROCKVILLE, Md., March 28, 2017 (GLOBE NEWSWIRE) -- REGENXBIO Inc. (Nasdaq:RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, today announced that Olivier

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RGNX
Mar 21, 2017
RGNXGeneral

REGENXBIO Announces Pricing of Public Offering of Common Stock ROCKVILLE, Md.

REGENXBIO Announces Pricing of Public Offering of Common Stock ROCKVILLE, Md., March 21, 2017 REGENXBIO Inc. (Nasdaq:RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV Techno

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RGNX
Mar 7, 2017
RGNXPhases

REGENXBIO Reports Fourth Quarter and Full-Year 2016 Financial Results and Recent Operational Highlights &#x2022; IND for RGX-314 Phase I trial for wet AMD is active and dosing initiated for RGX-501 Phase I/II trial for H

REGENXBIO Reports Fourth Quarter and Full-Year 2016 Financial Results and Recent Operational Highlights ROCKVILLE, Md., March 7, 2017 (GLOBE NEWSWIRE) -- REGENXBIO Inc. (Nasdaq:RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative po

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RGNX
Mar 7, 2017
RGNXPhases

REGENXBIO Announces Initiation of Phase I/II Clinical Trial of RGX-501 for the Treatment of Homozygous Familial Hypercholesterolemia

First AAV gene therapy treatment for HoFH; interim trial update expected late 2017 ROCKVILLE, Md., March 07, 2017 (GLOBE NEWSWIRE) -- REGENXBIO Inc. (Nasdaq:RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene ther

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RGNX
Mar 6, 2017
RGNXConferences/Events

REGENXBIO to Present at the Cowen and Company 37th Annual Health Care Conference

ROCKVILLE, Md., March 06, 2017 (GLOBE NEWSWIRE) -- REGENXBIO Inc. (Nasdaq:RGNX), a leading biotechnology company focused on the development, commercialization and licensing of recombinant adeno-associated virus (AAV) gene therapy based on its proprietary NAV® Technology Platform,

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RGNX
Feb 28, 2017
RGNXGeneral

REGENXBIO Honors Rare Disease Day 2017

ROCKVILLE, Md., Feb. 28, 2017 (GLOBE NEWSWIRE) -- REGENXBIO Inc. (Nasdaq:RGNX), a leading biotechnology company focused on the development, commercialization and licensing of recombinant adeno-associated virus (AAV) gene therapy based on its proprietary NAV® Technology Platform,

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RGNX
Feb 28, 2017
RGNXConferences/Events

REGENXBIO to Host Conference Call on March 7 to Discuss Fourth Quarter and Full-Year 2016 Financial Results and Recent Operational Highlights

ROCKVILLE, Md., Feb. 28, 2017 (GLOBE NEWSWIRE) -- REGENXBIO Inc. (Nasdaq:RGNX), a leading biotechnology company focused on the development, commercialization and licensing of recombinant adeno-associated virus (AAV) gene therapy based on its proprietary NAV® Technology Platform,

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RGNX
Feb 14, 2017
RGNXPhases

REGENXBIO Announces IND Active for Phase I Trial of RGX-314 to Treat Wet Age-Related Macular Degeneration

Six leading U.S. retinal surgery centers expected to participate as enrollment sites in the trial Anticipate beginning trial enrollment by mid-2017; interim trial update expected by the end of 2017 ROCKVILLE, Md., Feb. 14, 2017 (GLOBE NEWSWIRE) -- REGENXBIO Inc. (Nasdaq:RGNX),

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RGNX
Feb 9, 2017
RGNXConferences/Events

REGENXBIO to Present at the 6th Annual LEERINK Partners Global Healthcare Conference

ROCKVILLE, Md., Feb. 09, 2017 (GLOBE NEWSWIRE) -- REGENXBIO Inc. (Nasdaq:RGNX), a leading biotechnology company focused on the development, commercialization and licensing of recombinant adeno-associated virus (AAV) gene therapy based on its proprietary NAV® Technology Platform,

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RGNX
Feb 2, 2017
RGNXFDA Updates

REGENXBIO to Participate in the SunTrust Robinson Humphrey 2017 Orphan Drug Day

ROCKVILLE, Md., Feb. 02, 2017 (GLOBE NEWSWIRE) -- REGENXBIO Inc. (Nasdaq:RGNX), a leading biotechnology company focused on the development, commercialization and licensing of recombinant adeno-associated virus (AAV) gene therapy based on its proprietary NAV® Technology Platform,

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RGNX
Jan 6, 2017
RGNXPhases

REGENXBIO Provides Year-End 2016 Corporate Update Filed IND for RGX-314 Phase I clinical trial for wet AMD Announced initiation of protocol changes for RGX-501 Phase I/II clinical trial for HoFH; patient enrollment is no

REGENXBIO Provides Year-End 2016 Corporate Update ROCKVILLE, Md., January 6, 2017 REGENXBIO Inc. (Nasdaq: RGNX), a leading biotechnology company focused on the development, commercialization and licensing of recombinant adeno-associated virus (AAV) gene therapy based on its pro

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RGNX
Jan 6, 2017
RGNXGeneral

REGENXBIO Provides Year-End 2016 Corporate Update

Filed IND for RGX-314 Phase I clinical trial for wet AMD Announced initiation of protocol changes for RGX-501 Phase I/II clinical trial for HoFH; patient enrollment is now projected to begin first half 2017 Anticipate enrolling patients in clinical trials for three lead program

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RGNX
Nov 29, 2016
RGNXGeneral

REGENXBIO and Voyager Therapeutics Announce Exercise of Options for Rights to NAV Vectors

ROCKVILLE, Md. and CAMBRIDGE, Mass., Nov. 29, 2016 (GLOBE NEWSWIRE) -- REGENXBIO Inc. (Nasdaq:RGNX), a leading biotechnology company focused on the development, commercialization and licensing of recombinant adeno-associated virus (AAV) gene therapy based on its proprietary NAV®

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RGNX
Nov 17, 2016
RGNXConferences/Events

REGENXBIO to Present at the 28th Annual Piper Jaffray Healthcare Conference

ROCKVILLE, Md., Nov. 17, 2016 (GLOBE NEWSWIRE) -- REGENXBIO Inc. (Nasdaq:RGNX), a leading biotechnology company focused on the development, commercialization and licensing of recombinant adeno-associated (AAV) gene therapy based on its proprietary NAV® Technology Platform (NAV),

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RGNX
Nov 9, 2016
RGNXPhases

REGENXBIO Reports Third Quarter 2016 Financial Results and Recent Operational Highlights &#x2022; On track to dose first patient for Phase I/II clinical trial of RGX-501 for the treatment of homozygous familial hyperchol

REGENXBIO Reports Third Quarter 2016 Financial Results and Recent Operational Highlights ROCKVILLE, Md., November 9, 2016 -- REGENXBIO Inc. (Nasdaq: RGNX), a leading biotechnology company focused on the development, commercialization and licensing of recombinant adeno-associated

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RGNX
Nov 2, 2016
RGNXConferences/Events

REGENXBIO to Host Conference Call on November 9 to Discuss Third Quarter 2016 Financial Results and Recent Operational Highlights

ROCKVILLE, Md., Nov. 02, 2016 (GLOBE NEWSWIRE) -- REGENXBIO Inc. (Nasdaq:RGNX), a leading biotechnology company focused on the development, commercialization and licensing of recombinant adeno-associated virus (AAV) gene therapy based on its proprietary NAV® Technology Platform,

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RGNX
Oct 4, 2016
RGNXConferences/Events

REGENXBIO to Present at the Jefferies Gene Editing and Gene Therapy Summit

ROCKVILLE, Md., Oct. 04, 2016 (GLOBE NEWSWIRE) -- REGENXBIO Inc. (Nasdaq:RGNX), a leading biotechnology company focused on the development, commercialization and licensing of recombinant adeno-associated virus (AAV) gene therapy based on its proprietary NAV® Technology Platform,

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RGNX
Sep 13, 2016
RGNXPhases

REGENXBIO Publishes Data from Ongoing Preclinical Studies of NAV Gene Therapy in Neurodegenerative Diseases

Preclinical study of RGX-111 for the treatment of Mucopolysaccharidosis Type I (MPS I) demonstrates disease correction from a single administration of NAV AAV9 in a canine model; expected to help establish minimum effective dose in humans Preclinical study of RGX-121 for the tre

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RGNX
Sep 12, 2016
RGNXConferences/Events

Forward-looking statements This presentation contains "forward-looking statements," within the meaning of the Private Securities Litigation Reform Act of 1995, regarding, among other things, the timing and success of pre

Corporate Presentation September 12, Forward-looking statements This presentation contains "forward-looking statements," within the meaning of the Private Securities Litigation Reform Act of 1995, regarding, among other things, the timing and success of preclinical studies and

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RGNX
Sep 7, 2016
RGNXConferences/Events

REGENXBIO to Participate in Global Healthcare Conferences

ROCKVILLE, Md., Sept. 07, 2016 (GLOBE NEWSWIRE) -- REGENXBIO Inc. (Nasdaq:RGNX), a leading biotechnology company focused on the development, commercialization and licensing of recombinant adeno-associated virus (AAV) gene therapy based on its proprietary NAV® Technology Platform,

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RGNX
Aug 16, 2016
RGNXGeneral

Daniel Tass Appointed to REGENXBIO Board of Directors ROCKVILLE, Md.

Daniel Tass Appointed to REGENXBIO Board of Directors ROCKVILLE, Md., August 16, 2016 REGENXBIO Inc. (Nasdaq:RGNX), a leading biotechnology company focused on the development, commercialization and licensing of recombinant adeno-associated virus (AAV) gene therapy based on its

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RGNX
Aug 9, 2016
RGNXPhases

REGENXBIO Reports Second Quarter 2016 Financial Results and Recent Operational Highlights On track to enroll first patients for Phase I/II clinical trial of RGX-501 for the treatment of homozygous familial hypercholester

REGENXBIO Reports Second Quarter 2016 Financial Results and Recent Operational Highlights ROCKVILLE, Md., August 9, 2016 -- REGENXBIO Inc. (Nasdaq: RGNX), a leading biotechnology company focused on the development, commercialization and licensing of recombinant adeno-associated

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RGNX
Aug 2, 2016
RGNXFDA Updates

FDA Grants Rare Pediatric Disease Designation to REGENXBIO s RGX-121 Gene Therapy for the Treatment of Mucopolysaccharidosis Type II (MPS II) ROCKVILLE, Md.

FDA Grants Rare Pediatric Disease Designation to REGENXBIO s RGX-121 Gene Therapy for the Treatment of Mucopolysaccharidosis Type II (MPS II) ROCKVILLE, Md., August 2, 2016 REGENXBIO Inc. (Nasdaq:RGNX), a leading biotechnology company focused on the development, commercializat

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RGNX
Aug 1, 2016
RGNXConferences/Events

REGENXBIO to Host Conference Call on August 9 to Discuss Second Quarter 2016 Financial Results and Recent Operational Highlights

ROCKVILLE, Md., Aug. 01, 2016 (GLOBE NEWSWIRE) -- REGENXBIO Inc. (Nasdaq:RGNX), a leading biotechnology company focused on the development, commercialization and licensing of recombinant adeno-associated virus (AAV) gene therapy based on its proprietary NAV® Technology Platform,

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RGNX
Jul 5, 2016
RGNXPhases

REGENXBIO Provides Update on Lead Gene Therapy Development Programs Phase I/II clinical trial of RGX-501 for the treatment of homozygous familial hypercholesterolemia is actively recruiting and screening patients; expect

REGENXBIO Provides Update on Lead Gene Therapy Development Programs ROCKVILLE, Md., July 5, 2016 REGENXBIO Inc. (Nasdaq:RGNX), a leading biotechnology company focused on the development, commercialization and licensing of recombinant adeno-associated virus (AAV) gene therapy ba

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RGNX
May 16, 2016
RGNXGeneral

REGENXBIO and Biogen Enter Exclusive License Agreement for the Development of Gene Therapy Treatments for Rare Genetic Vision Disorders

ROCKVILLE, Md., May 16, 2016 (GLOBE NEWSWIRE) -- REGENXBIO Inc. (Nasdaq:RGNX), a leading biotechnology company focused on the development, commercialization and licensing of recombinant adeno-associated virus (AAV) gene therapy based on its proprietary NAV® Technology Platform, t

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RGNX
May 5, 2016
RGNXPhases

REGENXBIO Reports First Quarter 2016 Financial Results and Recent Operational Highlights On track to initiate a Phase I/II clinical trial for RGX-501 for the treatment of homozygous familial hypercholesterolemia in the f

REGENXBIO Reports First Quarter 2016 Financial Results and Recent Operational Highlights ROCKVILLE, Md., May 5, 2016 REGENXBIO Inc. (REGENXBIO or the Company) (Nasdaq: RGNX), a leading biotechnology company focused on the development, commercialization and licensing of recombin

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RGNX
May 3, 2016
RGNXConferences/Events

REGENXBIO to Participate in May Investor Conferences

ROCKVILLE, Md., May 03, 2016 (GLOBE NEWSWIRE) -- REGENXBIO Inc. (Nasdaq:RGNX), a leading biotechnology company focused on the development, commercialization and licensing of recombinant adeno-associated virus (AAV) gene therapy based on its proprietary NAV® Technology Platform, t

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RGNX
Apr 19, 2016
RGNXPhases

Preclinical Data from REGENXBIO s RGX-314 and RGX-121 Gene Therapy Programs to be Presented at the American Society of Gene & Cell Therapy 19th Annual Meeting High expression of anti-VEGF antibody achieved in rhesus maca

Preclinical Data from REGENXBIO s RGX-314 and RGX-121 Gene Therapy Programs to be Presented at the American Society of Gene & Cell Therapy 19th Annual Meeting ROCKVILLE, MD, April 19, 2016 REGENXBIO Inc. (Nasdaq:RGNX), a leading biotechnology company focused on the development,

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RGNX
Mar 3, 2016
RGNXGeneral

REGENXBIO Reports Fourth Quarter and Full-Year 2015 Financial Results and Recent Operational Progress Entered 2016 in strong financial position with more than $215 million in cash, cash equivalents and marketable securit

REGENXBIO Reports Fourth Quarter and Full-Year 2015 Financial Results and Recent Operational Progress ROCKVILLE, Md., March 3, 2016 REGENXBIO Inc. (Nasdaq: RGNX), a leading biotechnology company focused on the development, commercialization and licensing of recombinant adeno-as

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RGNX
Mar 1, 2016
RGNXGeneral

REGENXBIO Announces Appointment of Faraz Ali as Chief Business Officer

ROCKVILLE, Md., March 01, 2016 (GLOBE NEWSWIRE) -- REGENXBIO Inc. (Nasdaq:RGNX), a leading biotechnology company focused on the development, commercialization and licensing of recombinant adeno-associated virus (AAV) gene therapy based on its proprietary NAV® Technology Platform,

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RGNX
Jan 7, 2016
RGNXGeneral

REGENXBIO Provides Year-End 2015 Corporate Update

Company begins 2016 in strong financial position, on track to advance multiple lead gene therapy product candidate programs into clinic RGX-501 IND for treatment of homozygous familial hypercholesterolemia is active Five new NAV Vector licenses granted in the fourth quarter of

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RGNX
Jan 7, 2016
RGNXGeneral

REGENXBIO Provides Year-End 2015 Corporate Update Company begins 2016 in strong financial position, on track to advance multiple lead gene therapy product candidate programs into clinic RGX-501 IND for treatment of homoz

REGENXBIO Provides Year-End 2015 Corporate Update January 7, 2016 REGENXBIO Inc. (Nasdaq: RGNX), a leading biotechnology company focused on the development, commercialization and licensing of recombinant adeno-associated virus (AAV) gene therapy based on its proprietary NAV Tec

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RGNX
Dec 30, 2015
RGNXFDA Updates

FDA Grants Rare Pediatric Disease Designation to REGENXBIO s RGX-111 Gene Therapy for the Treatment of Mucopolysaccharidosis Type I (MPS I) ROCKVILLE, Md.

FDA Grants Rare Pediatric Disease Designation to REGENXBIO s RGX-111 Gene Therapy for the Treatment Mucopolysaccharidosis Type I (MPS I) ROCKVILLE, Md., December 30, 2015 REGENXBIO Inc. (Nasdaq:RGNX), a leading biotechnology company focused on the development, commercializatio

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RGNX
Dec 18, 2015
RGNXGeneral

REGENXBIO Added to Russell 2000(R) Index

ROCKVILLE, Md., Dec. 18, 2015 (GLOBE NEWSWIRE) -- REGENXBIO Inc. (Nasdaq:RGNX), a leading biotechnology company focused on the development, commercialization and licensing of recombinant adeno-associated virus (AAV) gene therapy, today announced the company was added to the Russe

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RGNX
Dec 1, 2015
RGNXConferences/Events

REGENXBIO to Participate in Upcoming Investor and Scientific Conferences

ROCKVILLE, Md., Dec. 1, 2015 (GLOBE NEWSWIRE) -- REGENXBIO Inc. (Nasdaq:RGNX), a leading biotechnology company focused on the development, commercialization and licensing of recombinant adeno-associated virus (AAV) gene therapy, today announced that President and CEO Kenneth T. M

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RGNX
Nov 5, 2015
RGNXGeneral

REGENXBIO Reports Third Quarter 2015 Results

ROCKVILLE, Md., Nov. 5, 2015 (GLOBE NEWSWIRE) -- REGENXBIO Inc. (Nasdaq:RGNX), a leading biotechnology company focused on the development, commercialization and licensing of recombinant adeno-associated virus (AAV) gene therapy, today reported recent operational highlights and fi

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RGNX
Nov 5, 2015
RGNXGeneral

REGENXBIO Reports Third Quarter 2015 Results Closed initial public offering raising $145.2 million in net proceeds ROCKVILLE, MD

REGENXBIO Reports Third Quarter 2015 Results Closed initial public offering raising $145.2 million in net proceeds ROCKVILLE, MD, November 5, 2015 REGENXBIO Inc. (Nasdaq: RGNX), a leading biotechnology company focused on the development, commercialization and licensing of reco

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RGNX
Oct 1, 2015
RGNXFDA Updates

FDA GRANTS ORPHAN DRUG DESIGNATION TO REGENXBIO S RGX-111 GENE THERAPY FOR THE TREATMENT OF MUCOPOLYSACCHARIDOSIS TYPE I (MPS I) ROCKVILLE, MD

FDA GRANTS ORPHAN DRUG DESIGNATION TO REGENXBIO S RGX-111 GENE THERAPY FOR THE TREATMENT OF MUCOPOLYSACCHARIDOSIS TYPE I (MPS I) ROCKVILLE, MD, October 1, 2015 REGENXBIO Inc. (REGENXBIO) (Nasdaq: RGNX), a leading biotechnology company in gene therapy, today announced that the

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RGNX
Sep 22, 2015
RGNXGeneral

REGENXBIO Announces Closing of Initial Public Offering and Full Exercise of Underwriters' Option to Purchase Additional Shares

ROCKVILLE, Md., Sept. 22, 2015 (GLOBE NEWSWIRE) -- REGENXBIO Inc. (Nasdaq:RGNX), a leading biotechnology company in gene therapy, today announced the closing of its initial public offering of 7,245,000 shares of common stock at a public offering price of $22.00 per share, which i

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RGNX
Sep 17, 2015
RGNXGeneral

REGENXBIO Inc. (Nasdaq: RGNX) to Ring The Nasdaq Stock Market Opening Bell

ADVISORY, Sept. 17, 2015 (GLOBE NEWSWIRE) -- REGENXBIO Inc. (Nasdaq:RGNX), a leading biotechnology company in gene therapy, will visit the Nasdaq MarketSite in Times Square to celebrate its recent initial public offering (IPO). In honor of the occasion, Ken Mills, President and

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RGNX
Sep 17, 2015
RGNXGeneral

REGENXBIO Announces Pricing of Initial Public Offering

ROCKVILLE, Md., Sept. 16, 2015 (GLOBE NEWSWIRE) -- REGENXBIO Inc. ("REGENXBIO"), a leading biotechnology company in gene therapy, today announced the pricing of its initial public offering of 6,300,000 shares of its common stock at a public offering price of $22.00 per share, bef

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RGNX
Jun 11, 2015
RGNXGeneral

REGENXBIO Enters Into Strategic Manufacturing Collaboration With Wuxi Apptec

ROCKVILLE, Md. and SHANGHAI, China, June 11, 2015 (GLOBE NEWSWIRE) -- REGENXBIO Inc., a leading biotechnology company in gene therapy, today announced that it has entered into an exclusive strategic manufacturing collaboration with WuXi AppTec, Inc (WuXi). WuXi is a leading techn

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RGNX
May 20, 2015
RGNXGeneral

REGENXBIO Secures $70.5 Million in a Mezzanine Financing

ROCKVILLE, Md., May 20, 2015 (GLOBE NEWSWIRE) -- REGENXBIO Inc., a leading biotechnology company in gene therapy, today announced the successful completion of a heavily oversubscribed $70.5 million Series D financing. The Series D brings the total capital raised since inception t

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RGNX
Apr 23, 2015
RGNXGeneral

REGENXBIO and Dimension Therapeutics Add Development of Treatments for Two Metabolic Diseases to Exclusive License Agreement

ROCKVILLE, Md., April 23, 2015 (GLOBE NEWSWIRE) -- REGENXBIO Inc., a leading biotechnology company in gene therapy, today announced that it has added the indications of ornithine transcarbamylase deficiency (OTC) and Glycogen Storage Disease Type 1a (GSD1a) to its existing licens

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RGNX
Apr 8, 2015
RGNXGeneral

REGENXBIO Licenses Key Technologies From University of Pennsylvania and University of Minnesota for the Development of Treatments for MPS I and MPS II

WASHINGTON, April 8, 2015 (GLOBE NEWSWIRE) -- REGENXBIO Inc., a leading biotechnology company in gene therapy, today announced that it has entered into separate license and research agreements with the University of Pennsylvania (Penn) and University of Minnesota (U of M) related

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RGNX
Jan 21, 2015
RGNXGeneral

REGENXBIO Raises $30 Million in Series C Financing

WASHINGTON, Jan. 21, 2015 (GLOBE NEWSWIRE) -- REGENXBIO Inc., a leading biotechnology company in gene therapy, today announced the completion of a $30 million Series C financing. Venrock and Brookside Capital led the financing with participation from Deerfield Management and an u

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RGNX
Nov 25, 2014
RGNXConferences/Events

REGENXBIO to Present at 26th Annual Piper Jaffray Healthcare Conference

WASHINGTON, Nov. 25, 2014 (GLOBE NEWSWIRE) -- REGENXBIO Inc. today announced that Ken Mills, President and Chief Executive Officer, will present a company overview at the 26th Annual Piper Jaffray Healthcare Conference in New York City on Tuesday, December 2, 2014 at 2:50 p.m. ES

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RGNX
Oct 28, 2014
RGNXGeneral

REGENXBIO Appoints Dr. Stephen Yoo as Chief Medical Officer

WASHINGTON, Oct. 28, 2014 (GLOBE NEWSWIRE) -- REGENXBIO Inc. today announced the appointment of Stephen Yoo, M.D. as Chief Medical Officer, effective immediately. Dr. Yoo will oversee the development of REGENXBIO's AAV gene therapy treatments for lysosomal storage disorders and o

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RGNX
Sep 29, 2014
RGNXGeneral

REGENXBIO's NAV(R) Technology Demonstrates Correction of Cardiovascular Symptoms of MPS I in Animal Model

WASHINGTON, Sept. 29, 2014 (GLOBE NEWSWIRE) -- REGENXBIO Inc. today announced that gene transfer mediated by REGENXBIO's NAV AAV8 vectors resulted in sustained serum -L-iduronidase (IDUA) expression, as well as correction of systemic features of MPS I, or Hurler syndrome, a lysos

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