The FDA has awarded orphan drug designation to Sensorion SA's OTOF-GT, a dual vector AAV gene therapy, for the treatment of otoferlin gene-mediated hearing loss.
Acousia Therapeutics GmbH, and its partners at the Tübingen Hearing Research Center at University of Tübingen, have generated new preclinical data in support of hearing loss drug candidates ACOU-085 and ACOU-082.
The volatile gene therapy space is getting a boost with Eli Lilly and Co.’s acquisition of Akouos Inc., which only a month before had received the first IND from the U.S. FDA for an adeno-associated virus (AAV)-based hearing loss treatment. Lilly plans to pay about $610 million for the company to get at AK-OTOF, Akouos’ lead candidate for treating hearing loss due to mutations in the otoferlin gene.
Decibel Therapeutics Inc. has received clearance from the FDA for its IND application to initiate a phase I/II trial of DB-OTO in pediatric patients, potentially in infants younger than 2 years of age.
Akouos Inc. has received IND clearance from the FDA to initiate a first-in-human phase I/II pediatric trial of AK-OTOF, a gene therapy intended for the treatment of patients with otoferlin gene (OTOF)-mediated hearing loss.
The EMA's Committee for Orphan Medicinal Products (COMP) has adopted a positive opinion on Sensorion SA's application seeking orphan drug designation for OTOF-GT, a gene therapy intended for the treatment of otoferlin gene-mediated hearing loss.
The U.S. FDA gave Envoy Medical Corp. the thumbs up to conduct an early feasibility study of its Acclaim cochlear implant. The fully implanted system, which earned a breakthrough device designation from the FDA, aims to be the first cochlear implant to address hearing loss without the use of any external components.
Cochlear Ltd. will acquire Danish hearing implant company Oticon Medical A/S for AU$170 million (US$121 million) after parent company the Demant Group said it planned to exit its hearing implants business. Cochlear CEO Dig Howitt said that Oticon Medical is expected to add AU$75 to AU$80 million to Sydney-based Cochlear’s annual revenue, although Oticon Medical is currently “loss making.” In 2021, Demant’s hearing Implants saw revenue of $73 million.
DUBLIN – Auris Medical Holding Ltd., an early pioneer of targeted therapy for hearing disorders, is planning to exit the field and pivot into RNA-based therapeutics by acquiring a U.S. firm, Trasir Therapeutics Inc., which has developed an oligonucleotide delivery platform for delivery of short interfering RNA and other therapeutic RNA payloads to sites outside the liver.
