| Catalyst | Drug/Treatment | Stage | Probability of Approval | Description | Drug Type | Therapeutic Area | Source |
|---|---|---|---|---|---|---|---|
BLA Submission example | NAVSUNLI (clemidsogene lanparvovec-sngl, RGX-121) Mucopolysaccharidosis II (MPS II), Hunter syndrome PriorityFast TrackAccelerated+3 | BLA | — | Subscribe to access the data. | Gene Therapies | Rare Diseases | |
BLA Submission example | NAVSUNLI (clemidsogene lanparvovec-sngl, RGX-121) Mucopolysaccharidosis II (MPS II), Hunter syndrome PriorityFast TrackAccelerated+3 | BLA | — | Subscribe to access the data. | Gene Therapies | Rare Diseases | |
BLA Submission example | NAVSUNLI (clemidsogene lanparvovec-sngl, RGX-121) Mucopolysaccharidosis II (MPS II), Hunter syndrome PriorityFast TrackAccelerated+3 | BLA | — | Subscribe to access the data. | Gene Therapies | Rare Diseases |
Recent Updates
Recently added Catalysts
REGENXBIO Inc.
$12.02
+1.09 (+9.85%)
C 49Pipeline Score Overvalued Biotech · Clinical
Market Cap
793.48 M
EPS
-2.98
P/E Ratio
-
Value Trade
10.37 M
10.17 %
Week
16.47 %
1 Month
101.34 %
3 Month
52.15 %
6 Month
-82.29 %
5 Year
-79.02 %
All Time
Cash Data
Cash Position
-
Monthly Burn
-
Runway
-
Overview
Volume
1.14 M
52 Week Range
5.46 - 16.19
% held by Insiders
8.13 %
% held by Institutions
63.16 %
Enterprise Value
687.96 M
Total Shares
66.01 M
Short %
11.86 %
Float Shares
39.56 M
Company Description
locked
Upcoming Catalyst
Catalyst Timeline
Dated clinical, regulatory & corporate events for REGENXBIO Inc.
1051Total events
18Upcoming
230Tier-1 (high impact)
2015 – 2027Coverage
Upcoming catalysts 2
TBD
T1Topline Readout
Subscribe to view catalyst details
TBD
T2Runway Guidance Update
Subscribe to view catalyst details
Event history 2
TBD
●Quarterly UpdateCorporate
Subscribe to view catalyst details
TBD
▲Primary Endpoint MetRGX-202FiledClinical Data
Subscribe to view catalyst details
Past FDA Catalysts & PDUFA Decisions
| Date | Drug | Catalyst | Stage | Outcome | Reaction | Event Move % | Best Trade % |
|---|---|---|---|---|---|---|---|
2026-07-31 | surabgene lomparvovec (sura-vec, ABBV-RGX-314) | Phase 2 data readout | Phase 2 | — | – | – | – |
2026-07-31 | surabgene lomparvovec (sura-vec, ABBV-RGX-314) | Phase 2 data readout | Phase 2 | — | – | – | – |
2026-07-31 | surabgene lomparvovec (sura-vec, ABBV-RGX-314) | Phase 2 data readout | Phase 2 | — | – | – | – |
Drug Pipeline Intelligence
C49
Pipeline Score $146M
Pipeline ValueOvervalued
Valuation Signal5
Drugs Scored0.3x
rNPV / MCap Top 79%
Micro Cap (rank 197 of 931)
Percentile RankREGENXBIO Inc. carries a moderate pipeline score (49/100), with $365M risk-adjusted pipeline value, led by RGX-202 in Duchenne Muscular Dystrophy (Phase 2).
Showing 1 of 1 assets
| Drug | Indication | Phase | NCT ID | PTRS | rNPV | Status | Enrollment | Velocity | Design | Completion | ML Signal | Last Change |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| RGX-202 Gene therapy | Duchenne Muscular Dystrophy | Phase 2 | NCT05693142 | 55% | $187M | ACTIVE NOT_RECRUITING | 65 | AVERAGE | C (44) | Jun 1, 2028 | ELEVATED_RISK | MEDIUM Jul 21, 2026 |
Clinical Trial Results
| Drug Name | Indications | Phase | Date | Trial Results Summary | Title | Source |
|---|---|---|---|---|---|---|
surabgene lomparvovec | wet AMD and diabetic retinopathy | Phase 1/2a | 2026-07-18 | Stable to improved vision through 5 years in wet AMD patients; No drug-related intraocular inflammation observed; >2-step DRSS improvement in majority of NPDR participants at 2.5 years Read More | REGENXBIO Presents Positive Long-Term Data for Surabgene Lomparvovec in Wet AMD and Diabetic Retinopathy at American Society of Retina Specialists Annual Meeting Read More | |
surabgene lomparvovec | wet AMD and diabetic retinopathy | Phase 1/2a | 2026-07-18 | Stable to improved vision through 5 years in wet AMD patients; No drug-related intraocular inflammation observed; >2-step DRSS improvement in majority of NPDR participants at 2.5 years Read More | REGENXBIO Presents Positive Long-Term Data for Surabgene Lomparvovec in Wet AMD and Diabetic Retinopathy at American Society of Retina Specialists Annual Meeting Read More | |
surabgene lomparvovec | wet AMD and diabetic retinopathy | Phase 1/2a | 2026-07-18 | Stable to improved vision through 5 years in wet AMD patients; No drug-related intraocular inflammation observed; >2-step DRSS improvement in majority of NPDR participants at 2.5 years Read More | REGENXBIO Presents Positive Long-Term Data for Surabgene Lomparvovec in Wet AMD and Diabetic Retinopathy at American Society of Retina Specialists Annual Meeting Read More |
Inside Trades
YEARLY INSIDER TRANSACTIONS
Sector Avg.
INSIDERS
SOLDINSIDERS
BOUGHT
SOLDINSIDERS
BOUGHT
POSITIVE SENTIMENT Based on 22 Insiders Transactions
Hedge Funds
Shares Held
HEDGE FUNDS
SOLDHEDGE FUNDS
BOUGHT
SOLDHEDGE FUNDS
BOUGHT
POSITIVE SENTIMENT Based on 27 hedge funds in the last quarter
18 buying (3 new)·9 selling (1 exited)·2 unchanged
Hedge Funds invested in RGNX
| 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 |
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
| Expiration | Volume | Open Interest | Implied Volatility Calls | Implied Volatility Puts | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Calls | Puts | Put-Call Ratio | Calls | Puts | Put-Call Ratio | IV | OiWaIv | VWaIv | IV | OiWaIv | VWaIv | |
| 2026-10-16 | 0.00 | 0 | - | - | - | - | - | - | ||||
| 2026-10-16 | 0.00 | 0 | - | - | - | - | - | - | ||||
| 2026-10-16 | 0.00 | 0 | - | - | - | - | - | - | ||||
Option Chain
| Calls | Strike | Puts | ||||
|---|---|---|---|---|---|---|
| Last Price | Volume | Open Interest | Last Price | Volume | Open Interest | |
| No data available | ||||||
Open interest
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
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▲ +7.4%on this news
REGENXBIO Reports Second Quarter 2026 Financial Results and Operational Highlights
REGENXBIO reported strong financial results and operational highlights for Q2 2026, with a focus on advancing its gene therapy pipeline. Key developments include the initiation of the RGX-202 BLA submission for Duchenne muscular dystrophy and positive data from ongoing trials for RGX-121 and surabgene lomparvovec. The company raised over $200 million to support its operations and extend its cash runway into Q4 2027.
Read more →RGNXREGENXBIO to Host Conference Call on August 6 to Discuss Second Quarter 2026 Financial Results and Operational Highlights
REGENXBIO Inc. will host a conference call on August 6, 2026, at 8:00 a.m. ET to discuss its second quarter financial results and operational highlights. The call will include a question and answer session for analysts. A replay will be available shortly after the call concludes.
Read more →RGNXREGENXBIO Presents Positive Long-Term Data for Surabgene Lomparvovec in Wet AMD and Diabetic Retinopathy at American Society of Retina Specialists Annual Meeting
REGENXBIO presented positive long-term data for surabgene lomparvovec (sura-vec) at the ASRS Annual Meeting. The gene therapy demonstrated stable to improved vision in wet AMD patients over five years, with no drug-related intraocular inflammation. Additionally, it showed significant improvements in diabetic retinopathy patients at 2.5 years. Topline data from pivotal studies are expected in Q4 2026.
Read more →RGNX▼ -11.7%on this newsshared move
REGENXBIO Announces Pricing of Public Offering of Common Stock and Pre-funded Warrants
REGENXBIO Inc. has announced the pricing of a public offering of over 10 million shares of common stock at $9.00 each, along with pre-funded warrants. The offering is expected to raise around $100 million and is set to close on July 20, 2026. The company has granted underwriters a 30-day option to purchase additional shares.
Read more →RGNX▲ +12.9%on this news· ran to +27% by day 3
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 →RGNXREGENXBIO 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▲ +16.3%on this news· ran to +31% by day 3shared move
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 →RGNXREGENXBIO 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▼ -37.8%on this newsshared move
REGENXBIO Reports First Quarter 2026 Financial Results and Operational Highlights Company announced positive topline results from pivotal Phase III AFFINITY DUCHENNE® study of RGX-202 Primary endpoint achieved with high statistical ...
REGENXBIO reported positive topline results from its Phase III AFFINITY DUCHENNE study for RGX-202, achieving its primary endpoint with high statistical significance. The company is advancing its gene therapy programs, including RGX-121 and surabgene lomparvovec, while also managing a significant net loss and reduced cash reserves. The firm expects to submit for accelerated approval in 2027, indicating strong future potential despite current financial challenges.
Read more →RGNX▼ -37.8%on this newsshared move
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▼ -37.8%on this newsshared move
REGENXBIO Reports First Quarter 2026 Financial Results and Operational Highlights • 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 →RGNXREGENXBIO Announces Presentations at the American Society of Gene & 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.
Read more →RGNX▲ +10.8%on this newsshared move
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.
Read more →RGNXREGENXBIO 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.
Read more →RGNX▼ -5.3%on this news
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.
Read more →RGNXREGENXBIO 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.
Read more →RGNXREGENXBIO 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.
Read more →RGNX▲ +5.2%on this news· ran to +19% by day 3shared move
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▲ +5.6%on this newsshared move
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.
Read more →RGNXREGENXBIO 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.
Read more →RGNX▼ -14.2%on this news
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.
Read more →RGNXEX-99.1
REGENXBIO, in collaboration with AbbVie, is advancing treatments for wet AMD and diabetic retinopathy. The company highlights the potential of its gene therapies while cautioning about risks and uncertainties related to future outcomes.
Read more →RGNX▼ -17.9%on this news
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.
Read more →RGNXREGENXBIO 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.
Read more →RGNXREGENXBIO 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.
Read more →RGNX▲ +10%on this news
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 →RGNXREGENXBIO 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.
Read more →RGNXREGENXBIO 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 →RGNXREGENXBIO 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 →RGNXREGENXBIO 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.
Read more →RGNXREGENXBIO 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.
Read more →RGNXREGENXBIO 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.
Read more →RGNXREGENXBIO 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.
Read more →RGNXREGENXBIO Announces FDA Review Extension of BLA for RGX-121 to Treat Patients with MPS II REGENXBIO Inc. (Nasdaq: RGNX) today announced that the U.S. Food and Drug Administration (FDA) extended its review timeline of the Biologics License...
REGENXBIO announced an extension of the FDA review timeline for its Biologics License Application (BLA) for RGX-121, a potential treatment for MPS II. The new Prescription Drug User Fee Act goal date is set for February 8, 2026. The extension follows the submission of additional long-term clinical data, which showed positive results. The company remains on track for a commercial launch and plans to present updated data at the ICIEM meeting in September 2025.
Read more →RGNXREGENXBIO 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 →RGNXREGENXBIO Reports Second Quarter 2025 Financial Results and Operational Highlights RGX-202 in Duchenne muscular dystrophy on track for topline results 1H 2026 and BLA submission mid-2026 Pivotal trial enrollment accelerated,...
REGENXBIO reported strong operational progress in Q2 2025, with RGX-202 for Duchenne muscular dystrophy on track for topline results in early 2026. The company also highlighted successful FDA inspections for RGX-121, which is expected to be the first gene therapy for MPS II. Additionally, pivotal trial data for sura-vec in retinal diseases is anticipated in 2026. However, the company reported a net loss of $70.9 million, reflecting challenges in revenue generation.
Read more →RGNXREGENXBIO 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 →RGNXREGENXBIO Reports Second Quarter 2025 Financial Results and Operational Highlights • 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 →RGNXREGENXBIO 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.
Read more →RGNXREGENXBIO 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.
Read more →RGNX▼ -17.1%on this news
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.
Read more →RGNX▲ +16.9%on this newsshared move
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.
Read more →RGNX▲ +10.1%on this news
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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REGENXBIO Announces Strategic Royalty Monetization Agreement for Up to $250 Million REGENXBIO Inc. (Nasdaq: RGNX) today announced the closure of a non-dilutive, limited recourse royalty bond agreement of up to $250 million with...
REGENXBIO has closed a non-dilutive royalty bond agreement worth up to $250 million with Healthcare Royalty. The initial $150 million received extends the company's cash runway into early 2027, allowing for advancement in gene therapy projects. This financing also retains future non-dilutive funding opportunities, enhancing REGENXBIO's position in the market.
Read more →RGNXREGENXBIO 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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REGENXBIO Reports First Quarter 2025 Financial Results and Recent Operational Highlights • 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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REGENXBIO Reports First Quarter 2025 Financial Results and Recent Operational Highlights RGX-202 in Duchenne muscular dystrophy on track for BLA submission mid-2026 Pivotal trial more than half enrolled, with completion expected in 2025...
REGENXBIO Inc. reported its first quarter 2025 financial results, highlighting progress in its gene therapy pipeline. The pivotal trial for RGX-202 in Duchenne muscular dystrophy is over half enrolled, with a BLA submission expected in mid-2026. The company also anticipates FDA acceptance of the BLA for RGX-121 in May 2025. Financially, REGENXBIO showed a notable revenue increase, attributed to its partnership with Nippon Shinyaku.
Read more →RGNXREGENXBIO 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.
Read more →RGNXREGENXBIO 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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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.
Read more →RGNXREGENXBIO Reports Fourth Quarter and Full Year 2024 Financial Results and Recent Operational Updates Biologics Licensing Application (BLA) for clemidsogene lanparvovec (RGX-121) submitted and on track for potential FDA approval 2H 2025; strategic...
REGENXBIO has submitted a Biologics Licensing Application (BLA) for clemidsogene lanparvovec (RGX-121), targeting potential FDA approval in the second half of 2025. The company is also advancing its pivotal trial for RGX-202 in Duchenne Muscular Dystrophy, with completion expected in 2025. Financial results show a decrease in revenues, primarily due to lower royalties from Zolgensma.
Read more →RGNXREGENXBIO Reports Fourth Quarter and Full Year 2024 Financial Results and Recent Operational Updates • 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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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.
Read more →RGNXREGENXBIO 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.
Read more →RGNXREGENXBIO Announces Closing of Strategic Partnership with Nippon Shinyaku for MPS Diseases REGENXBIO Inc. (Nasdaq: RGNX) today announced the closing of its previously announced strategic partnership with Nippon Shinyaku. Under the terms of...
REGENXBIO has finalized its strategic partnership with Nippon Shinyaku to develop RGX-121 and RGX-111 for MPS diseases. RGX-121 aims to be the first gene therapy for MPS II, with potential FDA approval by late 2025. Both therapies are designed to address significant unmet medical needs in the MPS community.
Read more →RGNXREGENXBIO 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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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.
Read more →RGNXREGENXBIO and Nippon Shinyaku Announce Exclusive Partnership to Develop and Commercialize RGX-121 and RGX-111 for MPS Diseases REGENXBIO Inc. (Nasdaq: RGNX) and Nippon Shinyaku Co., Ltd. (Nippon Shinyaku) today announced a strategic partnership for the development and...
REGENXBIO and Nippon Shinyaku have announced a strategic partnership to develop RGX-121 and RGX-111 for MPS diseases. REGENXBIO will receive $110 million upfront, with potential milestone payments of up to $700 million. Nippon Shinyaku will lead commercialization efforts in the U.S. and Asia, while REGENXBIO retains rights to a Priority Review Voucher for RGX-121. The partnership aims to leverage both companies' strengths in gene therapy.
Read more →RGNXREGENXBIO 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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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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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 approval; BLA expected in 2026 Pivotal trial of RGX-202...
REGENXBIO has announced the initiation of the pivotal phase of the AFFINITY DUCHENNE trial for RGX-202, a gene therapy for Duchenne muscular dystrophy. The first patient has been dosed, and the trial aims for a Biologics License Application by 2026. Phase I/II data indicate significant functional improvements and a favorable safety profile, aligning with FDA expectations for accelerated approval.
Read more →RGNXREGENXBIO 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.
Read more →RGNX▲ +5.7%on this news· ran to +30% by day 3
REGENXBIO Reports Third Quarter 2024 Financial Results and Recent Operational Updates Advancement in Phase I/II AFFINITY DUCHENNE® trial of RGX-202 for Duchenne Muscular Dystrophy; pivotal trial initiation and first functional data...
REGENXBIO reported its third quarter 2024 financial results, highlighting advancements in its clinical trials, including the AFFINITY DUCHENNE trial for RGX-202 and the BLA submission for RGX-121. Positive data from the Phase II trials of ABBV-RGX-314 were noted, supporting its potential as a treatment for wet AMD and diabetic retinopathy. Despite a net loss of $59.6 million, the company remains optimistic about its pipeline and upcoming milestones.
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REGENXBIO Reports Third Quarter 2024 Financial Results and Recent Operational Updates • 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.
Read more →RGNXREGENXBIO 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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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.
Read more →RGNXREGENXBIO 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.
Read more →RGNXREGENXBIO 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.
Read more →RGNXREGENXBIO Appoints Mitchell Chan as Chief Financial Officer • Life sciences veteran Mitchell Chan joins the company ahead of multiple catalysts across late-stage gene therapy programs • 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.
Read more →RGNXREGENXBIO Appoints Mitchell Chan as Chief Financial Officer REGENXBIO Inc. (Nasdaq: RGNX) today announced that Mitchell Chan has been appointed as Executive Vice President and Chief Financial Officer,...
REGENXBIO Inc. has appointed Mitchell Chan as the new Chief Financial Officer, effective immediately. Chan, a seasoned finance executive with nearly 20 years in the biotechnology sector, succeeds Vit Vasista, who will assist in the transition until January 2025. The company anticipates significant growth as it advances its gene therapy pipeline.
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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.
Read more →RGNXREGENXBIO 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.
Read more →RGNXREGENXBIO 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.
Read more →RGNX▼ -6.6%on this news
REGENXBIO Reports Second Quarter 2024 Financial Results and Recent Operational Highlights • 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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REGENXBIO Reports Second Quarter 2024 Financial Results and Recent Operational Highlights Company remains on track for its first BLA filing in 2024 and is accelerating progress toward pivotal trial initiation for Duchenne (H2 2024) and...
REGENXBIO reported its second quarter 2024 financial results, highlighting progress in its clinical pipeline. The company is set to file its first BLA in 2024 and has received positive data from the Phase II AFFINITY DUCHENNE trial for RGX-202. Additionally, it plans to initiate pivotal trials for RGX-202 and ABBV-RGX-314 in late 2024 and early 2025, respectively. The company's financial position remains strong with $327 million in cash.
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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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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.
Read more →RGNX▲ +6.4%on this news
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.
Read more →RGNXREGENXBIO 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.
Read more →RGNXREGENXBIO 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.
Read more →RGNXREGENXBIO 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.
Read more →RGNXREGENXBIO 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.
Read more →RGNXREGENXBIO Reports First Quarter 2024 Financial Results and Recent Operational Highlights Company remains on track for its first BLA filing in 2024 and is accelerating progress toward pivotal trial initiation for Duchenne (H2 2024) and...
REGENXBIO reported its Q1 2024 financial results, highlighting progress in its pipeline, including plans for a BLA filing in 2024 and pivotal trials for Duchenne and diabetic retinopathy. The company announced positive interim data for RGX-202 and maintains a strong cash position to support operations through 2026. However, it also reported a net loss and a decrease in revenues compared to the previous year.
Read more →RGNXREGENXBIO Reports First Quarter 2024 Financial Results and Recent Operational Highlights • 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.
Read more →RGNX▲ +5.5%on this news
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.
Read more →RGNX▼ -5%on this news
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.
Read more →RGNXREGENXBIO 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.
Read more →RGNXREGENXBIO 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.
Read more →RGNXREGENXBIO 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.
Read more →RGNXREGENXBIO Announces Pricing of Upsized Public Offering of Common Stock and Pre-funded Warrants REGENXBIO Inc. (Nasdaq: RGNX) a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy, ...
REGENXBIO Inc. has announced the pricing of an upsized public offering of 4,565,260 shares of common stock at $23.00 per share, along with 1,521,740 pre-funded warrants priced at $22.9999 each. The gross proceeds from this offering are expected to be around $140 million, with the closing anticipated on March 11, 2024. The offering includes a 30-day option for underwriters to purchase additional shares.
Read more →RGNX▲ +15.2%on this newsshared move
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.
Read more →RGNX▼ -12.4%on this news· ran to +24% by day 3shared move
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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REGENXBIO Reports Fourth Quarter and Full Year 2023 Financial Results and Recent Operational Highlights • 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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REGENXBIO Reports Fourth Quarter and Full Year 2023 Financial Results and Recent Operational Highlights Focus on clinical stage AAV Therapeutic product candidates addressing large commercial opportunities and value generation Prioritized pipeline is...
REGENXBIO reported its financial results for Q4 and full year 2023, highlighting advancements in its AAV therapeutic pipeline. The company anticipates pivotal trial progress and a BLA filing in 2024. Despite a net loss of $62.9 million in Q4, REGENXBIO maintains a strong cash position of $314 million, expected to fund operations into 2025.
Read more →RGNXREGENXBIO 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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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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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.
Read more →RGNXREGENXBIO 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.
Read more →RGNXREGENXBIO 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.
Read more →RGNXREGENXBIO 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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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.
Read more →RGNXREGENXBIO 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.
Read more →RGNXREGENXBIO Announces Updated Strategic Plans and Third Quarter 2023 Financial Results Announces pipeline prioritization and corporate restructuring to focus on clinical stage AAV Therapeutic product candidates addressing large...
REGENXBIO Inc. has announced a strategic pipeline prioritization and corporate restructuring aimed at enhancing operational efficiency and focusing on high-value AAV therapeutic candidates. Key programs include ABBV-RGX-314 for wet AMD and RGX-202 for Duchenne muscular dystrophy. The restructuring is expected to yield at least $100 million in savings while the company maintains a strong cash position to support operations through 2025.
Read more →RGNXREGENXBIO Announces Updated Strategic Plans and Third Quarter 2023 Financial Results • 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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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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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.
Read more →RGNXREGENXBIO 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.
Read more →RGNXREGENXBIO 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.
Read more →RGNXREGENXBIO 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.
Read more →RGNXREGENXBIO 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.
Read more →RGNXInitial 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.
Read more →RGNXREGENXBIO 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.
Read more →RGNXREGENXBIO Reports Second Quarter 2023 Financial Results and Recent Operational Highlights • Continued progress on ‘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.
Read more →RGNXREGENXBIO Reports Second Quarter 2023 Financial Results and Recent Operational Highlights Continued progress on '5x'25' strategy to advance five AAV Therapeutics from REGENXBIO's internal pipeline and licensed programs into pivotal-stage...
REGENXBIO Inc. reported its financial results for Q2 2023, highlighting progress on its '5x'25 strategy to advance five AAV therapeutics. The company announced positive safety results from its RGX-202 program and completed enrollment for the Phase III RGX-121 trial. Despite a net loss of $72.1 million, REGENXBIO maintains a strong cash position of $415 million, ensuring operational continuity into 2025.
Read more →RGNXREGENXBIO 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.
Read more →RGNXREGENXBIO 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.
Read more →RGNXREGENXBIO 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.
Read more →RGNXREGENXBIO 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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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.
Read more →RGNXREGENXBIO 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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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.
Read more →RGNXREGENXBIO 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.
Read more →RGNXREGENXBIO 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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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.
Read more →RGNXREGENXBIO Reports First Quarter 2023 Financial Results and Recent Operational Highlights - Continued progress on ‘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.
Read more →RGNXREGENXBIO 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.
Read more →RGNXREGENXBIO 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.
Read more →RGNXREGENXBIO 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.
Read more →RGNXREGENXBIO 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.
Read more →RGNXREGENXBIO Reports Fourth Quarter 2022 and Full-Year 2022 Financial Results and Recent Operational Highlights - Continued progress on ‘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.
Read more →RGNXAdditional 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.
Read more →RGNXAdditional 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.
Read more →RGNXREGENXBIO 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.
Read more →RGNXREGENXBIO 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.
Read more →RGNXREGENXBIO 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.
Read more →RGNXREGENXBIO 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.
Read more →RGNXREGENXBIO 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.
Read more →RGNXREGENXBIO 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.
Read more →RGNXREGENXBIO 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.
Read more →RGNXREGENXBIO 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.
Read more →RGNXREGENXBIO 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.
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNX▼ -13.2%on this news
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
Read more →RGNX▼ -13.2%on this news
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
Read more →RGNXREGENXBIO 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
Read more →RGNX▼ -8.6%on this news
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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNX▲ +6.9%on this news
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
Read more →RGNX▲ +6.9%on this news
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. "
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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.
Read more →RGNX▲ +5.4%on this newsshared move
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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNX▲ +5.4%on this newsshared move
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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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:
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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.
Read more →RGNXREGENXBIO 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
Read more →RGNX▲ +6.1%on this news
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
Read more →RGNXREGENXBIO 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)
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNX▲ +31.2%on this news
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
Read more →RGNXDr. 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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.
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO
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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO Reports Third Quarter 2020 Financial Results and Operational Highlights • RGX-314 subretinal pivotal wet AMD trial expected to initiate in Q1 2021 • 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO Reports Second Quarter 2020 Financial Results and Operational Highlights • 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO Reports First Quarter 2020 Financial Results and Operational Highlights • 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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 (
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO Reports Fourth Quarter and Full-Year 2019 Financial Results and Operational Highlights • Additional data from RGX-314 Phase I/IIa trial for wet AMD expected in 1H 2020 • 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO Reports Third Quarter 2019 Financial and Operating Results and Recent Operational Highlights • 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXKey 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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 • 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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 • 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO Reports Fourth Quarter and Full-Year 2018 Financial Results and Recent Operational Highlights • 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXFDA 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
Read more →RGNXREGENXBIO 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 • 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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 • 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),
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXAlexandra 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO Reports First Quarter 2018 Financial Results and Recent Operational Highlights • Completed dosing of third cohort in RGX-314 Phase I clinical trial for wet AMD • 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO Reports Fourth Quarter and Full-Year 2017 Financial Results and Recent Operational Highlights • Completed dosing of third cohort in RGX-314 Phase I clinical trial for wet AMD • 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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.
Read more →RGNXREGENXBIO 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.
Read more →RGNXREGENXBIO 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.
Read more →RGNXREGENXBIO 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.
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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.
Read more →RGNXREGENXBIO Reports Third Quarter 2017 Financial Results and Recent Operational Highlights • Completed second cohort dosing in RGX-314 Phase I clinical trial for wet AMD • 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO Reports Second Quarter 2017 Financial Results and Recent Operational Highlights • Enrollment continues in RGX-314 Phase I clinical trial for wet AMD; interim update anticipated by year-end 2017 •
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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO Reports First Quarter 2017 Financial Results and Recent Operational Highlights • 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO Reports Fourth Quarter and Full-Year 2016 Financial Results and Recent Operational Highlights • 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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,
Read more →RGNXREGENXBIO 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,
Read more →RGNXREGENXBIO 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,
Read more →RGNXREGENXBIO 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),
Read more →RGNXREGENXBIO 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,
Read more →RGNXREGENXBIO 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,
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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®
Read more →RGNXREGENXBIO 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),
Read more →RGNXREGENXBIO Reports Third Quarter 2016 Financial Results and Recent Operational Highlights • 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
Read more →RGNXREGENXBIO 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,
Read more →RGNXREGENXBIO 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,
Read more →RGNXREGENXBIO 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
Read more →RGNXForward-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
Read more →RGNXREGENXBIO 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,
Read more →RGNXDaniel 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
Read more →RGNXREGENXBIO 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
Read more →RGNXFDA 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
Read more →RGNXREGENXBIO 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,
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXPreclinical 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,
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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,
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXFDA 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXFDA 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO 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
Read more →RGNXREGENXBIO'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
Read more →Competitive Position
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