enGene Holdings Inc.
detalimogene voraplasmid
high-risk, non-muscle invasive bladder cancer (NMIBC)
Countdown
177days
FDA decision · ~ Dec 31, 2026 estimated
What's at stake
The FDA's approval decision on detalimogene voraplasmid for high-risk, non-muscle invasive bladder cancer (NMIBC) is due ~ Dec 31, 2026. A green light opens the market; a complete response letter (CRL) usually sinks the stock.
Primary source
· SEC 8-K
verified 13h ago
“the planned Biologics License Application (“BLA”) to the U.S. Food and Drug Administration (“FDA”) for detalimogene voraplasmid as a treatment for high-risk, Bacillus Calmette-Guérin (“BCG”)-unresponsive non-muscle invasive bladder cancer (”