secwatch.observer — SEC 8-K summary
======================================

Issuer:     enGene Therapeutics Inc. (ENGN)
CIK:        0001980845
Form:       8-K
Filed at:   2024-09-26T23:59:59+00:00
Accession:  0000950170-24-109463
Event type: other_material
Sentiment:  positive
Materiality: 0.80
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

- 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.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1980845/000095017024109463/0000950170-24-109463-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1980845/000095017024109463/engn-20240926.htm
  HTML page:      https://secwatch.observer/filing/0000950170-24-109463

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