---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-25-275722"
form_type: "8-K"
ticker: "ENGN"
cik: "0001980845"
company_name: "enGene Therapeutics Inc."
filed_at: "2025-11-12T23:59:59+00:00"
generated_at: "2026-05-16T21:44:40.220042+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

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

## Summary
- 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%.

## SEC filing metadata
- accession: 0001193125-25-275722
- form_type: 8-K
- ticker: ENGN
- cik: 0001980845
- company_name: enGene Therapeutics Inc.
- filed_at: 2025-11-12T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1980845/000119312525275722/0001193125-25-275722-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1980845/000119312525275722/d28722d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-25-275722
- JSON: https://secwatch.observer/filing/0001193125-25-275722.json
- Plain text: https://secwatch.observer/filing/0001193125-25-275722.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.