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FINWIRES

Regeneron Says FDA Granted Accelerated Approval for Genetic Hearing Loss Therapy

-- Regeneron (REGN) said Thursday that the US Food and Drug Administration has granted accelerated approval for Otarmeni therapy indicated for the treatment of pediatric and adult patients with OTOF gene-related hearing loss.

FDA's approval was based on the ongoing Chord trial that showed 16 of 20 participants experienced hearing improvements per pure tone audiometry assessments, while 14 out of 20 demonstrated an auditory brainstem response, according to a statement.

Otarmeni's continued approval may be contingent upon verification and description of clinical benefit in the confirmatory portion of the Chord trial, Regeneron said.

The company said it will provide Otarmeni at no cost to clinically eligible individuals in the US.

Shares of the company were up 2% in Thursday trading.

Price: $761.47, Change: $+14.89, Percent Change: +1.99%

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