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 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.