Tag: orphan drug status

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Sensorion Announced Orphan Drug Designation for OTOF-GT

Sensorion (FR0012596468 – ALSEN) a clinical-stage biotechnology company which specializes in the development of novel therapies to restore, treat, and prevent within the field of hearing loss disorders, announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to OTOF-GT, Sensorion’s lead gene therapy program, intended for the treatment of otoferlin gene-mediated hearing loss. Sensorion is on track to file a Clinical Trial Application for OTOF-GT in the first half of 2023.

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