{"filings":[{"id":97048,"accession_number":"0001193125-26-210316","cik":1980845,"company_name":"enGene Therapeutics Inc.","ticker":"ENGN","form_type":"8-K","filed_at":"2026-05-07T23:59:59+00:00","items":["5.02","7.01","8.01","9.01"],"status":"ready","headline":"enGene reports 54% CR at any time in Phase 2 LEGEND trial; 43% CR at 6 months","event_type":"other_material","confidence":"high","bullets":["54% complete response (CR) at any time (67/124) and 43% CR at 6 months (52/121) in BCG-unresponsive NMIBC with CIS.","Progression to muscle-invasive disease was low at 3.2%; Kaplan-Meier 12-month CR rate estimate is 25%.","Safety profile favorable: 55% treatment-related adverse events, mostly Grade 1-2; 2.4% led to discontinuation.","Company plans continued FDA engagement for BLA; data to be presented at AUA on May 15; update expected H2 2026."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.8,"daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":97047,"accession_number":"0001193125-26-149597","cik":1980845,"company_name":"enGene Therapeutics Inc.","ticker":"ENGN","form_type":"8-K","filed_at":"2026-04-09T23:59:59+00:00","items":["5.03","7.01","9.01"],"status":"ready","headline":"enGene Holdings changes name to enGene Therapeutics Inc., signals commercial readiness for detalimogene","event_type":"other_material","confidence":"high","bullets":["Name change to enGene Therapeutics Inc. effective April 8, 2026; tickers ENGN/ENGNW unchanged.","BLA submission for detalimogene planned for 2H 2026 in BCG-unresponsive NMIBC with CIS.","Potential approval and commercial launch targeted for 2027.","New CUSIP numbers: common shares 29286X101, warrants 29286X119."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.45,"daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":111505,"accession_number":"0001193125-26-097546","cik":1980845,"company_name":"enGene Therapeutics Inc.","ticker":"ENGN","form_type":"8-K","filed_at":"2026-03-09T23:59:59+00:00","items":["1.01","1.02","9.01"],"status":"ready","headline":"enGene enters $100M at-the-market equity facility with Leerink Partners","event_type":"other_material","confidence":"high","bullets":["New Sales Agreement with Leerink Partners for up to $100M in common shares via at-the-market offerings.","Prior Open Market Sale Agreement with Jefferies LLC terminated on March 6, 2026; no shares sold and no penalties.","Leerink will receive a commission of up to 3.0% of gross proceeds; Company may reimburse certain expenses.","Shares will be sold under Rule 415(a)(4); Company not obligated to sell any shares.","No shares offered or sold in Canada under the new agreement."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.6,"daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":111504,"accession_number":"0001193125-26-097534","cik":1980845,"company_name":"enGene Therapeutics Inc.","ticker":"ENGN","form_type":"8-K","filed_at":"2026-03-09T23:59:59+00:00","items":["2.02","9.01"],"status":"ready","headline":"enGene Q1 net loss $29.8M; cash $312.5M; LEGEND data update at spring 2026 conference","event_type":"earnings","confidence":"high","bullets":["Net loss $29.8M ($0.44/share) vs $24.6M ($0.48/share) year ago; operating expenses $31.2M.","Cash & marketable securities $312.5M; expected runway into 2H 2028.","Expanded Hercules Capital debt facility to $125M for detalimogene development & commercial prep.","LEGEND pivotal cohort 63% CR at any time (n=62); BLA filing planned for 2H 2026.","12-month CR data expected 2H 2026; CDRP program selected by FDA."],"consensus_eps_estimate":null,"consensus_eps_actual":0.44,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":"2026-Q1","consensus_source":"xbrl_only","sentiment":"neutral","materiality_score":0.65,"daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":111503,"accession_number":"0001193125-26-017945","cik":1980845,"company_name":"enGene Therapeutics Inc.","ticker":"ENGN","form_type":"8-K","filed_at":"2026-01-21T23:59:59+00:00","items":["1.01","2.03","3.02","9.01"],"status":"ready","headline":"enGene expands loan facility to $125M; draws $25M initial tranche with Hercules Capital","event_type":"debt","confidence":"high","bullets":["Second Amendment increases term loan facility from $50M to up to $125M, with initial $25M advance to refinance prior debt.","New loans mature January 1, 2030; interest rate is prime + 2.25% (min 9.25%, capped at 10.25%).","End-of-term fee of 5.95% of aggregate principal; additional tranches tied to clinical, approval, and commercial milestones.","Issued 40,850 warrants at $9.18/share to Lenders as part of initial draw; up to 204,248 warrants possible if fully drawn.","Loan secured by substantially all assets including intellectual property; Hercules Capital acts as agent."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.65,"daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":111502,"accession_number":"0001193125-26-017226","cik":1980845,"company_name":"enGene Therapeutics Inc.","ticker":"ENGN","form_type":"8-K","filed_at":"2026-01-21T23:59:59+00:00","items":["7.01","9.01"],"status":"ready","headline":"enGene expands debt facility with Hercules to $125M, $25M funded to refinance existing debt","event_type":"debt","confidence":"high","bullets":["Up to $125M debt facility from Hercules Capital; $25M funded at closing to refinance existing debt.","Three additional tranches up to $75M available upon achieving clinical, regulatory, and commercial milestones; final $25M at Hercules' discretion.","Maturity date January 1, 2030; proceeds support detalimogene BLA filing in H2 2026 and potential launch in 2027.","Non-dilutive capital strengthens balance sheet for planned BLA in BCG-unresponsive NMIBC with carcinoma in situ."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.7,"daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":128130,"accession_number":"0001193125-25-328706","cik":1980845,"company_name":"enGene Therapeutics Inc.","ticker":"ENGN","form_type":"8-K","filed_at":"2025-12-22T23:59:59+00:00","items":["2.02","9.01"],"status":"ready","headline":"enGene FY2025 net loss $117.3M; LEGEND pivotal cohort complete (125 pts), 62% CR at 6 months; cash runway to 2H 2028","event_type":"earnings","confidence":"high","bullets":["FY2025 net loss $117.3M ($2.29/sh) vs $55.1M ($1.46/sh) in 2024; R&D expenses up $56.2M to $123.2M total OpEx.","LEGEND pivotal cohort enrollment complete with 125 patients; preliminary CR rate 62% at 6 months (post-amendment patients).","Cash, equivalents, and marketable securities $202.3M at Oct 31, 2025; plus $140.1M net from Nov offering; runway into 2H 2028.","FDA selected enGene for CDRP program to support CMC readiness; BLA filing for detalimogene planned for 2H 2026.","Appointed Dr. Hussein Sweiti as CMO in September; he previously led J&J's bladder cancer portfolio leading to FDA approval."],"consensus_eps_estimate":null,"consensus_eps_actual":2.29,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":"2025-FY","consensus_source":"xbrl_only","sentiment":"positive","materiality_score":0.75,"daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":128129,"accession_number":"0001193125-25-283182","cik":1980845,"company_name":"enGene Therapeutics Inc.","ticker":"ENGN","form_type":"8-K","filed_at":"2025-11-14T23:59:59+00:00","items":["1.01","7.01","9.01"],"status":"ready","headline":"enGene prices $130M public offering of common shares and pre-funded warrants","event_type":"other_material","confidence":"high","bullets":["Pricing of 12,558,823 common shares at $8.50/share and pre-funded warrants for 2,735,295 shares at $8.4999 each.","Gross proceeds expected ~$130M before underwriting discounts and expenses.","Underwriters granted 30-day option to purchase up to 2,294,117 additional common shares.","Offering expected to close on or about November 14, 2025.","Proceeds to advance clinical-stage genetic medicines pipeline, including lead NMIBC candidate detalimogene."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.75,"daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":128128,"accession_number":"0001193125-25-275722","cik":1980845,"company_name":"enGene Therapeutics Inc.","ticker":"ENGN","form_type":"8-K","filed_at":"2025-11-12T23:59:59+00:00","items":["7.01","8.01","9.01"],"status":"ready","headline":"Detalimogene 62% CR at 6 months; primary endpoint changed; BLA on track H2 2026","event_type":"other_material","confidence":"high","bullets":["Post-protocol amendment patients achieved 62% CR at 6 months (n=37) and 63% at any time (n=62).","Primary endpoint for pivotal cohort changed to CR at any time following FDA discussions; duration of response is key secondary.","BLA submission for detalimogene planned in H2 2026; potential FDA approval in 2027.","Cash, cash equivalents and short-term investments of $202.4M as of Oct 31, 2025.","Safety: 42% patients had TRAEs, mainly Grade 1/2; no Grade 4/5; dose interruptions 1.6%, discontinuations 0.8%."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.75,"daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":128127,"accession_number":"0001193125-25-228351","cik":1980845,"company_name":"enGene Therapeutics Inc.","ticker":"ENGN","form_type":"8-K","filed_at":"2025-10-02T23:59:59+00:00","items":["5.02"],"status":"ready","headline":"enGene amends CEO Ron Cooper's severance to 1.5x target bonus on change-in-control termination","event_type":"other_material","confidence":"high","bullets":["Board approved amendment to Cooper Employment Agreement, effective October 2, 2025.","CIC termination severance multiplier increased from 1.0x to 1.5x annual target bonus.","Lump sum payment payable within 45 days of CIC termination, subject to compliance.","Amendment recommended by Compensation Committee; full text to be filed in 10-K for FY ending Oct 31, 2025."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.35,"daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":128126,"accession_number":"0001193125-25-228331","cik":1980845,"company_name":"enGene Therapeutics Inc.","ticker":"ENGN","form_type":"8-K/A","filed_at":"2025-10-02T23:59:59+00:00","items":["5.02"],"status":"ready","headline":"enGene Holdings appoints Astley-Sparke and Heffernan to board committees","event_type":"leadership","confidence":"high","bullets":["Philip Astley-Sparke appointed to Audit Committee and Nominating & Corporate Governance Committee.","Michael Heffernan appointed to Audit Committee and Compensation Committee.","Committee assignments effective October 2, 2025."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.25,"daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":144914,"accession_number":"0001193125-25-224053","cik":1980845,"company_name":"enGene Therapeutics Inc.","ticker":"ENGN","form_type":"8-K","filed_at":"2025-09-30T23:59:59+00:00","items":["7.01","9.01"],"status":"ready","headline":"enGene appoints Dr. Hussein Sweiti as CMO; former J&J bladder cancer lead","event_type":"leadership","confidence":"high","bullets":["Dr. Sweiti appointed Chief Medical Officer effective September 29, 2025.","Previously Global Medical Head, Oncology at J&J; led bladder cancer portfolio and recent FDA NMIBC approval.","Will oversee global clinical development for detalimogene; BLA submission planned for 2H 2026.","Brings 15+ years experience in surgical oncology, drug development, and regulatory submissions.","Appointed after target enrollment reached in pivotal detalimogene NMIBC trial."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.6,"daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":144913,"accession_number":"0000950170-25-114220","cik":1980845,"company_name":"enGene Therapeutics Inc.","ticker":"ENGN","form_type":"8-K","filed_at":"2025-09-11T23:59:59+00:00","items":["2.02","9.01"],"status":"ready","headline":"enGene Q3 net loss $28.9M; hits LEGEND enrollment target, RMAT designation","event_type":"earnings","confidence":"high","bullets":["Cash and marketable securities $224.9M; net loss $28.9M ($0.57/share) vs $14.1M ($0.32/share) YoY.","Achieved target enrollment of 100 patients in LEGEND pivotal cohort; data update expected 4Q 2025.","Detalimogene granted FDA RMAT designation; BLA submission planned for 2H 2026.","Operating expenses $29.9M, up from $16.8M; R&D costs increased $11M on LEGEND manufacturing and clinical costs.","Board appointed Philip Astley-Sparke, William Grossman, Michael Heffernan; promoted Matthew Boyd, Jill Buck, Katherine Chan."],"consensus_eps_estimate":null,"consensus_eps_actual":1.56,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":"2025-Q3","consensus_source":"xbrl_only","sentiment":"neutral","materiality_score":0.7,"daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":144912,"accession_number":"0000950170-25-112674","cik":1980845,"company_name":"enGene Therapeutics Inc.","ticker":"ENGN","form_type":"8-K","filed_at":"2025-09-03T23:59:59+00:00","items":["7.01","8.01","9.01"],"status":"ready","headline":"enGene achieves target enrollment of 100 patients in Phase 2 LEGEND trial for detalimogene in BCG-unresponsive NMIBC","event_type":"other_material","confidence":"high","bullets":["Target enrollment of 100 patients reached in Cohort 1 of Phase 2 LEGEND trial.","Trial evaluates detalimogene voraplasmid in high-risk, BCG-unresponsive NMIBC with CIS ± papillary disease.","Corporate presentation updated September 3, 2025; news release issued same day."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.65,"daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":144911,"accession_number":"0000929638-25-002520","cik":1980845,"company_name":"enGene Therapeutics Inc.","ticker":"ENGN","form_type":"8-K","filed_at":"2025-07-08T23:59:59+00:00","items":["5.02","7.01","9.01"],"status":"ready","headline":"enGene appoints Astley-Sparke, Grossman, Heffernan to board; promotes three executives","event_type":"leadership","confidence":"high","bullets":["Philip Astley-Sparke, William Grossman, Michael Heffernan appointed to Board effective July 8, 2025; Jasper Bos resigned.","Matthew Boyd promoted to Chief Regulatory Officer; Jill Buck to Chief Development Officer; Katherine Chan to Executive Director, Urology Clinical Lead.","New board members have experience in gene therapy, oncology, and product launches; company advancing detalimogene toward planned commercialization.","Board increased from seven to nine members after appointments; no disagreements cited for Bos resignation.","Independent director compensation plan applies; indemnification agreements entered."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.65,"daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":163300,"accession_number":"0000950170-25-085138","cik":1980845,"company_name":"enGene Therapeutics Inc.","ticker":"ENGN","form_type":"8-K","filed_at":"2025-06-12T23:59:59+00:00","items":["2.02","9.01"],"status":"ready","headline":"enGene Q2 loss $25.8M ($0.51/shr); cash $251.5M; LEGEND study on track","event_type":"earnings","confidence":"high","bullets":["Net loss $25.8M ($0.51/shr) vs $15.0M ($0.38) YoY; operating expenses $27.1M (up 57%).","Cash and marketable securities $251.5M expected to fund operations into 2027.","LEGEND pivotal cohort enrollment on track; BLA filing for detalimogene planned mid-2026.","EMA indicates data could support Conditional Marketing Authorization for BCG-unresponsive NMIBC.","Amy Pott appointed Chief Global Commercialization Officer effective May 2025."],"consensus_eps_estimate":-0.5081,"consensus_eps_actual":0.99,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":"2025-Q2","consensus_source":"xbrl+finnhub","sentiment":"neutral","materiality_score":0.6,"daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":163299,"accession_number":"0000929638-25-002215","cik":1980845,"company_name":"enGene Therapeutics Inc.","ticker":"ENGN","form_type":"8-K","filed_at":"2025-06-10T23:59:59+00:00","items":["5.02","5.07","9.01"],"status":"ready","headline":"Shareholders approve 2025 Employee Stock Purchase Plan; directors elected","event_type":"other","confidence":"high","bullets":["Shareholders approved the 2025 ESPP reserving 2,000,000 common shares for issuance.","Directors Gerald Brunk and Dr. Richard Glickman were elected with 30.5M and 26.3M for votes respectively.","ESPP effective June 10, 2025, allows eligible employees to purchase shares via payroll deductions.","Auditor appointment ratified with 38,101,229 votes in favor.","ESPP intended to qualify under Code Section 423; 74.6% of outstanding shares voted at the meeting."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.35,"daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":163298,"accession_number":"0000950170-25-083444","cik":1980845,"company_name":"enGene Therapeutics Inc.","ticker":"ENGN","form_type":"8-K","filed_at":"2025-06-09T23:59:59+00:00","items":["1.01","2.03","9.01"],"status":"ready","headline":"enGene signs 5-year lease for 26,335 sq ft Boston office; parent guarantees rent","event_type":"other_material","confidence":"high","bullets":["Lease with 99 High Street Owner LLC for office at 99 High Street, Boston, MA (26,335 rentable square feet).","Initial term of 5 years 5 months, starting ~June 19, 2025; rent abated for first 5 months.","Monthly base rent starts at ~$168,982 (Year 1) and escalates to ~$182,912 (Year 5), plus operating expenses and taxes.","Parent enGene Holdings Inc. executed an unconditional guaranty of all Tenant obligations under the Lease.","Rentable area is 3.60% of Building; base year for operating expenses is 2026, taxes fiscal year 2026."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.5,"daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":163297,"accession_number":"0000929638-25-002133","cik":1980845,"company_name":"enGene Therapeutics Inc.","ticker":"ENGN","form_type":"8-K","filed_at":"2025-06-04T23:59:59+00:00","items":["5.02","7.01","9.01"],"status":"ready","headline":"enGene CMO Dr. Raj Pruthi resigns; effective June 16, 2025","event_type":"leadership","confidence":"high","bullets":["Dr. Raj Pruthi resigned as Chief Medical Officer; resignation date June 3, 2025.","He will support orderly transition of responsibilities before leaving on June 16, 2025.","No successor named; responsibilities reallocated to other urology and clinical experts."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.55,"daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null}],"next_cursor":null}