Regeneron Pharmaceuticals, Inc.
Otarmeni
genetic hearing loss
Date
TBD
Approval decision · Date TBD estimated
What's at stake
A final FDA approval decision on Otarmeni for genetic hearing loss is expected Date TBD.
Primary source
· SEC 8-K
verified 14h ago
“Otarmeni (lunsotogene parvec, formerly known as DB-OTO), the first gene therapy approved under the FDA Commissioner’s National Priority Voucher program.”