enGene Holdings Inc.
detalimogene voraplasmid
high-risk, non-muscle invasive bladder cancer (NMIBC)
Date
TBD
FDA decision · Date TBD estimated
What's at stake
An FDA complete response letter on detalimogene voraplasmid for high-risk, non-muscle invasive bladder cancer (NMIBC) is in focus around Date TBD.
Primary source
· SEC 8-K
verified 14h ago
“12-month complete response data from LEGEND pivotal cohort expected in 2H 2026.”