---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-26-210316"
form_type: "8-K"
ticker: "ENGN"
cik: "0001980845"
company_name: "enGene Therapeutics Inc."
filed_at: "2026-05-07T23:59:59+00:00"
generated_at: "2026-05-14T22:05:26.182760+00:00"
event_type: "other_material"
sentiment: "neutral"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# enGene reports 54% CR at any time in Phase 2 LEGEND trial; 43% CR at 6 months

## Summary
- 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.

## SEC filing metadata
- accession: 0001193125-26-210316
- form_type: 8-K
- ticker: ENGN
- cik: 0001980845
- company_name: enGene Therapeutics Inc.
- filed_at: 2026-05-07T23:59:59+00:00
- event_type: other_material
- sentiment: neutral
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 5.02, 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1980845/000119312526210316/0001193125-26-210316-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1980845/000119312526210316/d335486d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-26-210316
- JSON: https://secwatch.observer/filing/0001193125-26-210316.json
- Plain text: https://secwatch.observer/filing/0001193125-26-210316.txt

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