Wednesday, May 6, 2026

A Tarrytown company just made medical history — and they're giving it away for free.

On April 23, Regeneron Pharmaceuticals received FDA approval for Otarmeni — the first gene therapy in the world approved to treat genetic hearing loss. The research that produced this came out of their headquarters in Tarrytown.

Otarmeni targets patients with severe-to-profound hearing loss caused by mutations in the OTOF gene — a genetic condition typically present from birth. In the pivotal clinical trial, 80% of participants achieved measurable hearing improvement within 24 weeks of a single treatment. With longer follow-up, 42% achieved normal hearing, including the ability to hear a whisper.

Why it matters: On the same day as the approval, Regeneron announced that Otarmeni will be provided at no cost to eligible patients in the United States. Gene therapies typically cost hundreds of thousands to millions of dollars — Regeneron chose a different model and reached an agreement with the federal government to make that policy official.

This is a Westchester story. Regeneron employs thousands of people in Westchester County. Their research campus in Tarrytown has been one of the county's most significant economic anchors for decades. What happened in those labs on April 23 is the kind of breakthrough that takes years to build — and this county is where it was built.

The therapy is currently approved for patients with confirmed OTOF gene mutations and no prior cochlear implant. FDA granted accelerated approval, meaning confirmatory trials are ongoing.

Listen to the full story on all podcast platforms.

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Regeneron has been in Tarrytown for over 30 years. Most people in this county couldn't tell you what they do. What Westchester company are you most proud to have here — that most people have never heard of? Hit reply.

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