Every 8-K that enGene Therapeutics Inc (ENGNW) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow ENGNW and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full ENGNW filings page.
enGene Therapeutics Inc. reported that it hosted a virtual key opinion leader event focused on emerging market research for non-muscle invasive bladder cancer (NMIBC) and its lead program, detalimogene voraplasmid. Management’s presentation describes detalimogene as a non-viral gene therapy being studied in multiple Phase 2 LEGEND cohorts for high-risk NMIBC, including BCG-unresponsive and BCG-naïve settings, with a cited 54% complete response rate at any time based on interim data as of April 21, 2026 and a tolerability profile the company characterizes as favorable.
The company states it has $285 million in cash and is targeting pivotal cohort 12‑month data and a potential BLA filing for detalimogene in the second half of 2026. Cited market research estimates an addressable U.S. NMIBC BCG-unresponsive population of about 20,000 patients, with most treated in community practices and many cycling through multiple lines of therapy. The slides also highlight benchmark U.S. NMIBC therapy pricing, with annual wholesale acquisition cost moving from $220,000 to about $690,000 per year, and discuss practice economics such as reliance on buy‑and‑bill reimbursement.
enGene Therapeutics Inc. provides an update on detalimogene voraplasmid, an investigational non‑viral gene therapy for high‑risk non‑muscle invasive bladder cancer (NMIBC). In the Phase 2 LEGEND pivotal Cohort 1 in BCG‑unresponsive NMIBC with carcinoma in situ, 125 patients were enrolled. Interim data as of 21 April 2026 show a 54% complete response at any time, with a 43.0% 6‑month complete response rate based on landmark and Kaplan‑Meier analyses.
The safety profile in this cohort shows 55.2% of participants experienced at least one treatment‑related adverse event, mostly grade 1–2, with 4.8% having grade ≥3 events, low dose interruptions and discontinuations (each 2.4%), and a median 8‑day resolution time. The company highlights plans to evaluate a polidocanol surfactant bladder rinse to potentially increase efficacy and durability while preserving ease of use, and notes $285M in cash is expected to support operations through planned BLA filing and potential approval, alongside an NMIBC market forecast of over $20B and a future total addressable patient population of more than 120,000.
enGene Therapeutics Inc. reported that longtime chairman and director Dr. Richard Glickman resigned from the board, effective July 15, 2026, and that existing director Michael Heffernan has been appointed chairman. The company states that Dr. Glickman’s resignation was not due to any disagreement regarding operations, policies, or practices.
The company highlights upcoming regulatory milestones for its lead program, detalimogene voraplasmid, a non-viral gene therapy in the Phase 2 LEGEND trial for high-risk non-muscle invasive bladder cancer. The pivotal Cohort 1 includes 125 patients with BCG-unresponsive disease and is intended to support a planned Biologics License Application, with a pre-BLA FDA meeting and initiation of BLA submission planned for the second half of 2026 and a potential FDA approval in 2027. Detalimogene has received RMAT and Fast Track designations and is included in the FDA’s CMC Development and Readiness Pilot program.
enGene Therapeutics Inc. filed an amended report updating details of its previously announced strategic restructuring, which includes reducing its workforce by about 50% to streamline operations and preserve cash. The company now expects restructuring cash costs of approximately $5.7–$6.4 million and non-cash stock-based compensation of about $4.7–$5.0 million, mainly from accelerated option vesting.
enGene also estimates up to $1.7 million in cash retention costs and up to $2.8 million in non-cash stock-based compensation tied to new performance-based equity retention awards. These awards, including a 400,000-share option grant to CEO Ronald Cooper at $1.75 per share, vest only if FDA milestones for detalimogene are met by late 2027 and 2028.
enGene Therapeutics reported a Q2 2026 net loss of $30.2 million, or $0.43 per share, as total operating expenses rose to $32.0 million from $27.1 million a year earlier, driven by higher research, clinical and administrative costs.
Cash, cash equivalents and marketable securities were $285.2 million as of April 30, 2026, supporting ongoing development of detalimogene. Interim data from the LEGEND pivotal Cohort 1 showed a 54% complete response rate (67/124 patients) with a 3.2% progression rate in high-risk BCG‑unresponsive NMIBC.
The company is implementing a strategic restructuring, including an approximately 50% workforce reduction, with estimated restructuring costs of $5.7–$6.4 million plus $4.7–$5.0 million in non‑cash stock‑based compensation. Several senior executives, including the CFO, CMO, CLO and CSO, are departing, while new finance leadership and an interim CMO have been appointed.
enGene Therapeutics Inc. reported the results of its 2026 Annual General Meeting of shareholders. The meeting was held on June 9, 2026, with 56,196,302 common shares represented, about 83.89% of the 66,989,466 shares outstanding and entitled to vote as of April 28, 2026.
Shareholders voted on the election of directors and on the appointment and remuneration of the auditor. Director nominees, including Philip Astley-Sparke and Ronald H.W. Cooper, each received more than 47.1 million votes “for,” with relatively few “withhold” votes and substantial broker non-votes. The auditor proposal received 56,180,287 votes “for” and 16,015 “withhold.”
enGene Therapeutics Inc. reported updated interim results from the pivotal Cohort 1 of its Phase 2 LEGEND trial of detalimogene voraplasmid in high-risk, BCG-unresponsive NMIBC, and amended the employment agreement of Dr. Hussein Sweiti. Among 125 patients, detalimogene achieved a 54% complete response rate at any time and 43% at six months, with a low 3.2% progression rate to muscle-invasive or more advanced disease. Treatment-related adverse events occurred in 55% of patients, were mainly Grade 1–2, and led to dose interruptions or discontinuations in 2.4% of patients each. A Kaplan-Meier estimate showed a 12‑month complete response rate of 25%, and later-enrolling patients had lower response rates than earlier subgroups, which the company is further analyzing.
enGene Therapeutics Inc., formerly enGene Holdings Inc., has changed its corporate name to enGene Therapeutics Inc., effective April 8, 2026. The amendment affects only the name; no other changes were made to the company’s articles. The company’s common shares and warrants will continue trading on Nasdaq under the symbols ENGN and ENGNW, respectively.
In a related press release, enGene explained that the new name reflects its transition toward potential commercialization of its lead gene therapy detalimogene voraplasmid. The company plans a Biologics License Application submission for detalimogene in the second half of 2026, targeting potential approval and a commercial organization in 2027.
enGene Holdings Inc. entered a new sales agreement with Leerink Partners that allows it to sell common shares from time to time in an at-the-market offering for an aggregate offering price of up to $100,000,000 under its existing shelf registration.
Leerink Partners will act as sales agent and receive a commission of up to 3.0% of the gross proceeds, with no obligation for enGene to sell or for Leerink to place any shares. In connection with this new arrangement, enGene terminated its prior open market sale agreement with Jefferies LLC, under which no common shares had been sold.
enGene Holdings Inc. reported a first quarter 2026 net loss attributable to common shareholders of approximately $29.8 million, or $0.44 per share, compared with about $24.6 million, or $0.48 per share, a year earlier. Operating expenses rose to $31.2 million from $26.6 million, driven by higher research and development spending on the LEGEND trial and preparation for a planned Biologics License Application, as well as increased general and administrative costs to support public company operations. Cash, cash equivalents and marketable securities were $312.5 million as of January 31, 2026, supported by a $140.1 million underwritten offering completed in November 2025 and an expanded $125 million debt facility with Hercules Capital, giving an expected cash runway into the second half of 2028. Preliminary data from the LEGEND pivotal cohort in high-risk, BCG-unresponsive non-muscle invasive bladder cancer showed complete response rates of 63% at any time (n=62), 56% at 3 months (n=62), and 62% at 6 months (n=37), with a generally favorable tolerability profile and low rates of treatment-related dose interruptions and discontinuations.
enGene Holdings Inc. entered into a Second Amendment to its loan and security agreement with Hercules Capital and other lenders, expanding its term loan facility from $50 million to up to $125 million, available in multiple milestone-based tranches. An initial $25 million Tranche 1 advance was funded on January 20, 2026 to refinance the prior term loans, and additional tranches of up to $35 million, $20 million, and $20 million are tied to defined clinical, approval and commercial milestones, plus an uncommitted $25 million tranche subject to lender approval.
The 2026 Term Loans mature on January 1, 2030 and bear interest at the greater of the prime rate plus 2.25% (capped at 10.25%) or 9.25%, with facility charges and a 5.95% end-of-term fee. The loans are secured by a senior lien on substantially all of the borrowers’ assets, including intellectual property. In connection with each loan advance, the lenders receive 2026 Warrants exercisable at $9.18 per share for seven years; on the Closing Date, they received 40,850 warrants, and the total potential issuance is capped at 204,248 warrants and underlying common shares if the full commitment is drawn.
enGene Holdings Inc. filed a current report describing a communication about its debt arrangements. The company announced that it entered into a Second Amendment to its Amended and Restated Loan and Security Agreement with Hercules Capital, Inc. and other lenders. This amendment builds on the original agreement dated December 22, 2023 and a prior amendment dated December 18, 2024, together referred to as the Amended Loan Agreement.
The company issued a press release on January 20, 2026 explaining the updated loan terms, which is furnished as an exhibit to the report rather than filed. As an emerging growth company with common shares and warrants listed on Nasdaq, enGene is using this report primarily to provide investors with notice of the press release and the existence of the amended loan agreement.
enGene Holdings Inc., a British Columbia company listed on The Nasdaq Stock Market LLC, furnished an update on its recent performance. The company announced its financial results for the third fiscal quarter ended July 31, 2025, and provided these details in a press release.
The press release, dated September 11, 2025, is attached as Exhibit 99.1. The company states that this information is being furnished rather than filed under the Securities Exchange Act of 1934, meaning it is not subject to certain liability provisions or automatically incorporated into other SEC filings. The report is signed by Chief Executive Officer and President Ronald H. W. Cooper.
enGene Holdings Inc. reported a clinical milestone and updated its investor materials. The company reached its target enrollment of 100 patients in Cohort 1, the pivotal cohort of the Phase 2 portion of the LEGEND trial evaluating detalimogene voraplasmid in high-risk, non-muscle invasive bladder cancer that is unresponsive to Bacillus Calmette-Guérin. Cohort 1 focuses on patients with carcinoma in-situ, with or without concomitant papillary disease. enGene also refreshed its Corporate Presentation and furnished it as an exhibit, while a press release describing the enrollment milestone was filed as a separate exhibit.
enGene Holdings Inc. (NASDAQ:ENGN, ENGNW) filed an 8-K covering board and management changes effective July 7-8, 2025.
- Director resignation: Jasper Bos resigned from the Board on July 7, 2025; the company states there was no disagreement regarding operations, policies or practices.
- Board appointments: The Board appointed Philip Astley-Sparke to fill the vacancy as of July 8, 2025, for the remainder of Bos’s term expiring at the 2026 AGM. The Board then increased its size from seven to nine and named William Grossman and Michael Heffernan as additional directors, each serving until the next AGM.
- Compensation & indemnification: All three new directors will participate in the company’s standard independent-director compensation plan and enter into indemnification agreements identical to those filed as Exhibits 10.17 and 10.18 to the 2024 Annual Report.
- Committee assignments: Not yet determined for the new directors.
- Management promotions (Reg FD disclosure): A July 8 press release (Exhibit 99.1) announced promotions of Matthew Boyd to Chief Regulatory Officer and Jill Buck to Chief Development Officer.
No transactions requiring disclosure under Item 404(a) were reported. The information furnished under Item 7.01 is expressly not deemed “filed” under the Exchange Act.