Financials
Cash Data
- Monthly Burn
- Burn Trend
- Dilution Risk
- SEC Filing
Key Stats
Upcoming Catalysts
FDA decisions, readouts and PDUFA dates · scored by probability of approval
ENGN Catalyst Timeline
Dated clinical, regulatory and corporate events for enGene Holdings Inc.
Catalyst Timeline
Dated clinical, regulatory & corporate events for enGene Holdings Inc.
Upcoming catalysts 2
Event history 50
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 % |
|---|---|---|---|---|---|---|
| 2025-12-31 | Detalimogene voraplasmid (also known as detalimogene, previously EG-70) | Phase 2 data readout | Phase 2 |
Drug Pipeline Intelligence
| Drug | Indication | Phase | PTRS | rNPV | Status | Enroll | Velocity | Design | Est. Completion | ML Signal | Last Change |
|---|---|---|---|---|---|---|---|---|---|---|---|
| EG-70 Small moleculeNCT04752722 | Superficial Bladder Cancer | Phase 2 | RECRUITING | 350 | Nov 1, 2028 |
Clinical Trial Results
Readouts, endpoints and source filings for every ENGN program
| Drug Name | Indication | Phase | Date | Trial Results Summary | Title | Source |
|---|---|---|---|---|---|---|
| detalimogene voraplasmid | high-risk non-muscle invasive bladder cancer (NMIBC) | Phase 2 | 2026-05-07 | complete 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 More | enGene Announces Updated Interim Results From LEGEND Pivotal CohortRead More |
Inside Trades
| Insider | Side | Shares | Price | Value | Date |
|---|---|---|---|---|---|
| Grossman WilliamDirector, Officer (Interim Chief Medical Officer) | Buy | 5,102 5,102 held | $1.97 | 09/22/2026 |
Hedge Fund 13F Activity
Hedge Funds invested in ENGN
| 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) |
ENGN Institutional Ownership Trends
Options Data
Option Volume
Option Chain Statistics
| Expiry | Call Vol | Put Vol | Vol P/C | Call OI | Put OI | OI P/C | IV Call | IV Call OI-Wtd | IV Call Vol-Wtd | IV Put | IV Put OI-Wtd | IV Put Vol-Wtd |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2026-11-20 | ||||||||||||
Real-Time Option Chain
| Calls | Strike | Puts | ||||
|---|---|---|---|---|---|---|
| Last | Vol | OI | Last | Vol | OI | |
| No data available | ||||||
Calls vs Puts by Expiry
Competitive positioning
How ENGN ranks across every disease it competes in
ENGN 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 →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.
Read more →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.
Read more →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.
Read more →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.
Read more →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.
Read more →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.
Read more →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.
Read more →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.
Read more →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.
Read more →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.
Read more →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.
Read more →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.
Read more →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.
Read more →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.
Read more →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.
Read more →