Decibel Therapeutics' Hearing Loss Gene Therapy Receives FDA Orphan Drug Tag

The FDA has granted both Orphan Drug Designation and Rare Pediatric Disease Designation to Decibel Therapeutics Inc (NASDAQ:DBTX) lead gene therapy product candidate, DB-OTO, for otoferlin-related congenital hearing loss.
The Company looks forward to initiating a Phase 1/2 trial of DB-OTO in pediatric patients in 2022.
Decibel may be eligible to receive one priority review voucher, which could be redeemed to receive priority review for a subsequent marketing application for a different product or sold or transferred to another sponsor.
DB-OTO is a dual-vector adeno-associated virus gene therapy product candidate designed to restore hearing in patients with congenital hearing loss caused by mutations in the otoferlin gene.
Related content: Benzinga's Full FDA Calendar.
Price Action: DBTX stock is up 3.36% at $7.97 during the market session on the last check Thursday.