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FDA approves Otarmeni, first gene therapy for severe genetic hearing loss linked to OTOF gene.

Market News
24 Apr 2026
Fda
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Bullish
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The FDA has approved Otarmeni (lunsotogene parvec-cwha), the first dual AAV vector-based gene therapy for treating severe-to-profound hearing loss caused by mutations in the OTOF gene. This one-time treatment delivers a functional gene to restore hearing in pediatric and adult patients with confirmed OTOF-related deafness, a condition previously without disease-modifying options. The approval was expedited under the National Priority Voucher program, marking a historic milestone in genetic hearing loss treatment. Continued approval will depend on long-term hearing improvement and impacts on speech development and quality of life.

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