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FDA approves Otarmeni, first gene therapy for genetic hearing loss, offered free in the U.S.

Market News
23 Apr 2026
GlobeNewsWire
View Source
Bullish
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The FDA has granted accelerated approval to Otarmeni (lunsotogene parvec-cwha), the first gene therapy for severe-to-profound hearing loss caused by OTOF gene variants. Developed by Regeneron, Otarmeni restores natural hearing by delivering a functional gene via intracochlear infusion. Clinical trials showed 80% of patients improved hearing, with 42% achieving normal hearing including whispers. Regeneron will provide Otarmeni free to eligible U.S. patients, marking a breakthrough in treating genetic hearing loss with gene therapy.

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