enGene Holdings Inc.
detalimogene voraplasmid
high-risk, non-muscle invasive bladder cancer (NMIBC)
Date
TBD
Approval decision · Date TBD estimated
What's at stake
A final FDA approval decision on detalimogene voraplasmid for high-risk, non-muscle invasive bladder cancer (NMIBC) is expected Date TBD.
Primary source
· SEC 8-K
verified 13h ago
“Access to the additional non-dilutive capital strengthens enGene’s balance sheet in preparation for its planned Biologics License Application (“BLA”) to the U.S. Food and Drug Administration (“FDA”) for detalimogene voraplasmid as a treatme”