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enGene Holdings Inc.

ENGN
OvervaluedBiotech · Clinical
FDA catalysts, PDUFA dates & pipeline intelligence
$1.73
▼ -0.05 · -2.81%

Financials

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52W LOW $1.4052W HIGH $12.25
Volume
358.85 K
Value Traded
816.28 K
Short % Float
4.22%
-7.49%Week
-3.89%1 Month
-6.99%3 Month
-76.72%6 Month
-78.93%5 Year
-79.42%All Time

Cash Data

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  • Burn Trend
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  • SEC Filing

Key Stats

Market Cap
115.94 M
EPS (TTM)
-1.95
P/E Ratio
-
Ent. Value
-150.38 M
Total Shares
66.98 M
Float Shares
28.44 M
Insiders
57.56%
Institutions
43.25%

Upcoming Catalysts

FDA decisions, readouts and PDUFA dates · scored by probability of approval

Catalyst Drug / Treatment Stage Prob. of Approval Description Drug Type Therapeutic Area Source
Pre-clinical data presentation
detalimogene plus surfactant (polidocanol)
high-risk, BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS)
Pre-clinicalGene TherapiesOncology
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Every FDA decision, readout and PDUFA date, with drug type, therapeutic area and a PoA score you can trade on.
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PoA blends historical approval base rates, trial design score and FDA review track record.

ENGN Catalyst Timeline

Dated clinical, regulatory and corporate events for enGene Holdings Inc.

Catalyst Timeline

Dated clinical, regulatory & corporate events for enGene Holdings Inc.

135Total events
13Upcoming
35Tier-1 (high impact)
2023 to 2027Coverage

Upcoming catalysts 2

T2Pre BLA Meeting
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detalimogeneFiled
T1BLA Submission
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detalimogeneFiled

Event history 50

▲Enrollment CompletedetalimogeneFiledTrial
Detalimogene plus surfactant cohort safety run-in successfully cleared
BCG-unresponsive NMIBC with CISsource ↗
●Quarterly UpdateCorporate
enGene Reports Third Quarter 2026 Financial Results
●R&D DayPresentation
Emerging NMIBC Market Insights KOL Webinar
non-muscle invasive bladder cancer (NMIBC)source ↗
◆Topline ReadoutdetalimogeneFiledClinical Data
12-month complete response data from LEGEND pivotal cohort
high-risk, BCG-unresponsive non-muscle invasive bladder cancer with CISsource ↗
●BLA SubmissiondetalimogeneFiledRegulatory Filing
BLA submission for detalimogene
high-risk, BCG-unresponsive non-muscle invasive bladder cancer with CISsource ↗
◆Full ResultsdetalimogeneFiledClinical Data
12-month complete response data for all of Cohort 1 expected
high-risk BCG-unresponsive NMIBC with CISsource ↗
●Management ChangeCorporate
Michael Heffernan assumed role of Chairman of the Board
●Quarterly UpdateCorporate
Second quarter 2026 financial results and business update
◆Management ChangeCorporate
Departure of CFO, CLO, CSO, and CMO; interim appointments
◆Timing Guidancedetalimogene voraplasmidFiledPresentation
Anticipated BLA filing for detalimogene in mid-2026
high-risk, BCG-unresponsive, non-muscle invasive bladder cancer with carcinoma in situsource ↗
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Past FDA Catalysts and PDUFA Decisions

How ENGN actually traded into and out of each decision

Date Drug Catalyst Stage Reaction Event Move % Best Trade %
2025-12-31Detalimogene voraplasmid (also known as detalimogene, previously EG-70) Phase 2 data readout Phase 2
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Reaction: 30 trading days around the event · Event Move: close to close on decision day · Best Trade: peak run-up from entry 10 days before the decision

Drug Pipeline Intelligence

D37 / 100
Pipeline Score
$59M
Pipeline Value
Overvalued
Valuation Signal
1
Drugs Scored
0.5x
rNPV / MCap
Top 47%
Micro Cap
(rank 311 of 660)
Percentile Rank
enGene Holdings Inc. faces pipeline headwinds (37/100), with $234M risk-adjusted pipeline value, led by EG-70 in Superficial Bladder Cancer (Phase 2).
Showing 1 of 1 assets
DrugIndicationPhasePTRSrNPVStatusEnrollVelocityDesignEst. CompletionML SignalLast Change
EG-70 Small moleculeNCT04752722Superficial Bladder CancerPhase 2 RECRUITING 350Nov 1, 2028
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Clinical Trial Results

Readouts, endpoints and source filings for every ENGN program

Drug Name Indication Phase Date Trial Results SummaryTitleSource
detalimogene voraplasmid high-risk non-muscle invasive bladder cancer (NMIBC)Phase 22026-05-07complete response rate any time: 54%; complete response rate 6 months: 43%; progression rate: 3.2%; duration of response: 25%; median duration of response weeks: 37.3 weeksRead MoreenGene Announces Updated Interim Results From LEGEND Pivotal CohortRead More
Scroll for more · summaries link to the source press release
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Inside Trades

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InsiderSideSharesPriceValueDate
Grossman WilliamDirector, Officer (Interim Chief Medical Officer)Buy 5,102 5,102 held$1.97 09/22/2026
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Hedge Fund 13F Activity

Fund % of Portfolio Current MV Shares Owned Activity
PERCEPTIVE ADVISORS LLC 0.8 % (-11.1 %) 39.69 M 5.83 M -0.71% ( -41.57 K)
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Shares held by hedge funds each quarter, and who bought or sold.

ENGN Institutional Ownership Trends

Options Data

Option Volume

Open Interest
Call OI
Put OI
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OI 30-day avg
Today vs avg
Option Volume
Call Vol
Put Vol
Put-Call Ratio
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Option Chain Statistics

ExpiryCall VolPut VolVol P/CCall OIPut OIOI P/CIV CallIV Call OI-WtdIV Call Vol-WtdIV PutIV Put OI-WtdIV Put Vol-Wtd
2026-11-20
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Real-Time Option Chain

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Calls vs Puts by Expiry

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Competitive positioning

How ENGN ranks across every disease it competes in

Competitive Position is a premium feature
See how ENGN ranks against every competitor across each disease it develops in: phase, best drug, trials and likelihood of approval.
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ENGN News

ENGN
Sep 8, 2026
ENGNGeneral
▲ +5.5%on this news

enGene Reports Third Quarter 2026 Financial Results and Provides Business Update

enGene Therapeutics Inc. reported its financial results for Q3 2026, highlighting progress in its clinical programs. The company is focusing on maturing regulatory endpoints data from its pivotal cohort and plans to engage with the FDA regarding a Biologics License Application for detalimogene. This update reflects enGene's ongoing commitment to advancing its genetic medicine initiatives.

Read more →
ENGN
Sep 1, 2026
ENGNConferences/Events

enGene to Participate in Upcoming Investor Conferences

enGene Therapeutics Inc. has announced its participation in two upcoming investor conferences. The Wells Fargo 21st Annual Healthcare Conference will take place on September 8, 2026, followed by the Morgan Stanley 24th Annual Global Healthcare Conference on September 14, 2026. These events will feature management in a fireside chat format, aiming to connect with investors.

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ENGN
Aug 4, 2026
ENGNConferences/Events

enGene to Host Virtual KOL Event to Discuss Emerging Non-Muscle Invasive Bladder Cancer (NMIBC) Market Insights, on August 11, 2026

enGene Therapeutics Inc. will host a virtual key opinion leader event on August 11, 2026, focusing on the non-muscle invasive bladder cancer (NMIBC) market. Dr. Neal Shore will provide insights into the treatment landscape, showcasing the company's commitment to advancing genetic medicine. This event aims to enhance understanding of NMIBC considerations.

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ENGN
Jul 16, 2026
ENGNGeneral

enGene Focuses Board to Support Planned Upcoming Regulatory and Commercial Milestones

enGene Therapeutics Inc. has announced changes to its Board of Directors to enhance support for upcoming regulatory milestones and commercial readiness for its product detalimogene voraplasmid. This product is currently under evaluation in the Phase 2 LEGEND trial, which aims to establish its safety and efficacy in high-risk patients. The company's strategic focus indicates a proactive approach to potential market entry.

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ENGN
Jun 15, 2026
ENGNGeneral
▲ +9.3%on this news

enGene Reports Second Quarter 2026 Financial Results and Provides Business Update

enGene has reported its financial results for the second quarter of 2026 and provided a business update. However, the article lacks specific details regarding the financial performance or business developments. The information presented is minimal and does not elaborate on any significant changes or outcomes.

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ENGN
May 7, 2026
ENGNPhases
▼ -80.6%on this news

enGene Announces Updated Interim Results From LEGEND Pivotal Cohort

enGene Therapeutics has reported updated interim results from the Phase 2 LEGEND trial of detalimogene voraplasmid for high-risk NMIBC patients. The trial showed a 54% complete response rate at any time and a low progression rate to muscle-invasive disease. While the treatment was generally well tolerated, durability outcomes were not as expected, prompting further evaluation.

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ENGN
Apr 7, 2026
ENGNGeneral

enGene Announces Name Change to enGene Therapeutics Inc.

enGene has announced a name change to enGene Therapeutics Inc. This rebranding reflects the company's focus on therapeutic development. The announcement is part of a broader strategy to enhance its market presence and align its identity with its mission.

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ENGN
Mar 9, 2026
ENGNFDA Updates
▼ -18.8%on this news

enGene Reports First Quarter 2026 Financial Results and Provides Business Update

enGene Holdings Inc. reported its first quarter 2026 financial results, highlighting a strong cash position and plans for a Biologics License Application (BLA) submission for detalimogene in the second half of 2026. The company anticipates presenting data from its LEGEND pivotal cohort at a spring medical conference. Despite an increase in net loss, enGene remains optimistic about the potential of detalimogene for treating high-risk bladder cancer.

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ENGN
Feb 20, 2026
ENGNConferences/Events

enGene to Participate in Upcoming Investor Conferences - February 20, 2026

enGene Holdings Inc. announced its participation in several upcoming investor conferences, including the Oppenheimer 36th Annual Healthcare Life Sciences Conference and the Barclays 28th Annual Global Healthcare Conference. The company is focused on developing genetic medicines, particularly its lead program for Non-Muscle Invasive Bladder Cancer. These events will provide opportunities for management to engage with investors and discuss their ongoing clinical trials.

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ENGN
Feb 5, 2026
ENGNConferences/Events
▼ -7.6%on this news

enGene to Participate in the Guggenheim Emerging Outlook: Biotech Summit 2026

enGene Holdings Inc. announced that CEO Ron Cooper will participate in a fireside chat at the Guggenheim Emerging Outlook: Biotech Summit 2026. The event is scheduled for February 11, 2026, and will be accessible via a live webcast. enGene is advancing genetic medicines, particularly its lead program for Non-Muscle Invasive Bladder Cancer.

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ENGN
Jan 21, 2026
ENGNFDA Updates

enGene Announces Expanded $125 Million Debt Facility with Hercules Capital, Inc.

enGene Holdings Inc. has announced an expanded debt facility of up to $125 million with Hercules Capital. The funding will support the development and commercialization of detalimogene voraplasmid for treating high-risk, BCG-unresponsive non-muscle invasive bladder cancer. The company plans to file a Biologics License Application with the FDA in the second half of 2026.

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ENGN
Dec 18, 2025
ENGNFDA Updates

enGene Reports Full Year 2025 Financial Results and Provides Business Update

enGene Holdings Inc. reported its financial results for the full year ended October 31, 2025, highlighting several significant milestones. The company completed enrollment in its pivotal LEGEND cohort with 125 patients and reported a 6-month complete response rate of 62%. enGene has also been selected for the FDA's CDRP Program, which aids in chemistry, manufacturing, and controls development. However, despite these developments, the company faced a net loss of approximately $117.3 million due to increased operating expenses.

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ENGN
Dec 2, 2025
ENGNFDA Updates

enGene’s Detalimogene Selected for FDA Manufacturing Pilot Program to Support Manufacturing Readiness

enGene Holdings Inc. announced that its investigational gene therapy, detalimogene voraplasmid, has been selected by the FDA for the CMC Development and Readiness Pilot Program. This program aims to enhance manufacturing readiness for therapies with compressed clinical timelines. The company also reported promising results from the LEGEND trial, showing a 62% complete response rate in patients with high-risk NMIBC.

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ENGN
Nov 12, 2025
ENGNGeneral

enGene Announces Pricing of $130 Million Public Offering of Common Shares and Pre-Funded Warrants

enGene Holdings Inc. has announced the pricing of its public offering, which aims to raise $130 million by offering 12,558,823 common shares at $8.50 each and pre-funded warrants at $8.4999 each. The company's public offering is set to close on or about November 14, 2025, pending customary closing conditions. The additional funds raised will further support the firm's clinical programs, particularly its lead candidate aimed at non-muscle invasive bladder cancer. Jefferies, Leerink Partners, and Wells Fargo Securities are among the firms managing the offering.

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ENGN
Nov 10, 2025
ENGNConferences/Events

enGene to Host Conference Call to Provide Update on Pivotal Cohort of LEGEND Trial

enGene Holdings Inc. will host a conference call on November 11, 2025, to discuss preliminary data from the pivotal cohort of its LEGEND trial. The trial focuses on its gene therapy candidate, detalimogene voraplasmid, targeted at patients with high-risk, BCG-unresponsive non-muscle invasive bladder cancer. This represents a significant step in the development of therapies addressing a high clinical need within this patient population.

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ENGN
Sep 30, 2025
ENGNGeneral
▲ +5.9%on this news· ran to +20% by day 3

enGene Appoints Hussein Sweiti, M.D., MSc, as Chief Medical Officer Bladder cancer development leader who helped drive recent FDA product approval in NMIBC joins to lead research and development strategy

enGene Holdings Inc. has appointed Dr. Hussein Sweiti as Chief Medical Officer, effective September 29, 2025. Dr. Sweiti brings extensive experience in oncology clinical research and regulatory submissions, having recently led successful FDA interactions for bladder cancer treatments at Johnson & Johnson. His appointment aims to enhance enGene's clinical development and regulatory capacity in preparation for the expected BLA submission for detalimogene, an investigational treatment for high-risk non-muscle invasive bladder cancer, anticipated in the second half of 2026.

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About enGene Holdings Inc.

82 employees engene.com
Headquarters4868 RUE LEVY, SUITE 220, SAINT-LAURENT
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