---
schema_version: "secwatch.filing_event.v1"
accession: "0000950170-24-109463"
form_type: "8-K"
ticker: "ENGN"
cik: "0001980845"
company_name: "enGene Therapeutics Inc."
filed_at: "2024-09-26T23:59:59+00:00"
generated_at: "2026-05-31T01:41:41.766244+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# Detalimogene shows 71% CR rate in LEGEND pivotal cohort; well-tolerated in BCG-unresponsive NMIBC

## Summary
- 71% complete response rate at any time (15/21 pts); 67% at 3 months; 47% at 6 months (8/17) in BCG-unresponsive NMIBC with Cis.
- No drug-related discontinuations; TRAEs mostly Grade 1/2; two Grade 3 (peripheral edema, urosepsis); no Grade 4/5.
- Median age 74; median 11 prior BCG doses; tumor stages: T1+Cis (14.3%), Ta+Cis (14.3%), Cis only (71.4%).
- Company plans protocol refinements; conference call at 8:00 AM ET on Sept 26.

## SEC filing metadata
- accession: 0000950170-24-109463
- form_type: 8-K
- ticker: ENGN
- cik: 0001980845
- company_name: enGene Therapeutics Inc.
- filed_at: 2024-09-26T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1980845/000095017024109463/0000950170-24-109463-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1980845/000095017024109463/engn-20240926.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0000950170-24-109463
- JSON: https://secwatch.observer/filing/0000950170-24-109463.json
- Plain text: https://secwatch.observer/filing/0000950170-24-109463.txt

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