enGene’s Detalimogene Selected for FDA Manufacturing Pilot Program to Support Manufacturing Readiness
enGene Holdings Inc. (ENGN)
Company Research
Source: Business Wire
enGene one of nine companies awarded CDRP per yearProgram aims to support CMC development of products with expedited clinical development timeframes and provide patients with earlier access to these productsDetalimogene has already been manufactured at commercial scale, and CDRP provides additional FDA CMC interactions ahead of a potential BLA submission in 2H 2026 BOSTON & MONTREAL--(BUSINESS WIRE)--enGene Holdings Inc. (Nasdaq: ENGN or “enGene” or the “Company”), a clinical-stage, non-viral genetic medicines company, today announced that the U.S. Food and Drug Administration (FDA) has selected detalimogene voraplasmid (also known as detalimogene and previously EG-70) to participate in the Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) Program. Detalimogene is a novel, investigational, non-viral gene therapy for patients with high-risk, non-muscle invasive bladder cancer (NMIBC).“Manufacturing readiness in drug development is often underappreci
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News
- enGene Holdings Inc (ENGN) Surging After Positive Phase 2 LEGEND Trial [Yahoo! Finance]Yahoo! Finance
- enGene (NASDAQ:ENGN) had its "buy" rating reaffirmed by analysts at HC Wainwright.MarketBeat
- enGene to Present at the Piper Sandler 37th Annual Healthcare ConferenceBusiness Wire
- enGene Announces Pricing of $130 Million Public Offering of Common Shares and Pre-Funded WarrantsBusiness Wire
- enGene Announces Proposed Public Offering of Common SharesBusiness Wire
ENGN
Sec Filings
- 11/18/25 - Form SCHEDULE
- 11/18/25 - Form SCHEDULE
- 11/14/25 - Form 8-K
- ENGN's page on the SEC website