secwatch.observer — SEC 8-K summary
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Issuer:     enGene Therapeutics Inc. (ENGN)
CIK:        0001980845
Form:       8-K
Filed at:   2025-11-12T23:59:59+00:00
Accession:  0001193125-25-275722
Event type: other_material
Sentiment:  positive
Materiality: 0.75
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Detalimogene 62% CR at 6 months; primary endpoint changed; BLA on track H2 2026
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- 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%.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1980845/000119312525275722/0001193125-25-275722-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1980845/000119312525275722/d28722d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-25-275722

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer