Akouos' Hearing Loss Gene Therapy Poised To Receive Orphan Drug Tag In Europe
- The European Medicines Agency (EMA) Committee for Orphan Medicinal Products has issued a positive opinion on Akouos Inc's (NASDAQ: AKUS) application for orphan drug designation for AK-OTOF.
- AK-OTOF is a gene therapy intended for the treatment of otoferlin gene-mediated hearing loss.
- The FDA previously granted AK-OTOF Orphan Drug Designation and Rare Pediatric Disease Designation for this same indication.
- Price Action: AKUS shares are down 4.30% at $11.80 during the market session on the last check Wednesday.
- Related content: Benzinga's Full FDA Calendar.
© 2025 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Posted-In: Biotech News Health Care Small Cap FDA Movers Trading Ideas General