Regeneron wins FDA approval for Otarmeni, first gene therapy for genetic hearing loss

24 April 2026

The US Food and Drug Administration (FDA) has granted accelerated approval for US biotech Regeneron Pharmaceuticals’ (Nasdaq: REGN) Otarmeni (lunsotogene parvec-cwha), the first gene therapy and second new molecular entity approved under the FDA Commissioner’s National Priority Voucher program. The firm’s shares were lifted 2.6% to $766.02 by the news,

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