Six years of collaboration is ending in a buyout, as Decibel Therapeutics Inc. agreed to be acquired by Regeneron Pharmaceuticals Inc. in a deal valued at up to $213 million, including $109 million in equity, with additional payments via contingent value rights linked to clinical and regulatory milestones for DB-OTO, the lead gene therapy program targeting hearing loss.
Sensorion SA has submitted a clinical trial application (CTA) for OTOF-GT to the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA). Sensorion plans to submit the CTA in Europe in the coming weeks.
Otoferlin is a calcium sensor protein critical for the transmission of the signal from inner hair cells (IHCs) to the spiral ganglion neurons (SGNs), and it is encoded by the OTOF gene. Pathogenic biallelic loss of function variations in OTOF result in failure of synaptic transmission, causing autosomal recessive deafness 9 (DFNB9), which is a congenital severe-to-profound auditory neuropathy.
Decibel Therapeutics Inc. has received clearance of its clinical trial application (CTA) by the U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA) to initiate a phase I/II trial of gene therapy DB-OTO in pediatric patients with congenital hearing loss due to an otoferlin deficiency.
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.
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.
