- The European Medicines Agency (EMA) Committee for Orphan Medicinal Products has issued a positive opinion on Akouos Inc's 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.
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