BCW Member Spotlight: Regeneron Achieves Groundbreaking FDA Approval in Gene Therapy

The Business Council of Westchester is proud to spotlight one of our members, Regeneron Pharmaceuticals, on a truly historic milestone in medical innovation.

On April 23, 2026, Regeneron announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Otarmeni™ (lunsotogene parvec-cwha) — the first and only gene therapy approved for a form of genetic hearing loss caused by mutations in the OTOF gene.

This breakthrough represents a major leap forward in the treatment of severe-to-profound sensorineural hearing loss. In clinical trials, the one-time therapy demonstrated remarkable results:

• 80% of participants experienced significant hearing improvement within 24 weeks
• 70% showed measurable auditory responses through objective testing
• 42% achieved normal hearing levels, including the ability to hear whispers, with longer follow-up

Otarmeni is the first FDA-approved gene therapy to restore a neurosensory function to near-normal levels—an achievement that underscores the transformative potential of genetic medicine.

In an extraordinary commitment to patient access, Regeneron has announced it will provide Otarmeni at no cost to eligible patients in the United States, helping ensure that this life-changing innovation reaches those who need it most.

This milestone also marks Regeneron’s first approved genetic medicine, highlighting the company’s continued leadership in pioneering therapies for serious and previously untreatable conditions.

As a cornerstone of Westchester’s business and scientific community, Regeneron continues to push the boundaries of innovation while making a meaningful global impact. We are proud to count them among our members and celebrate this achievement as a testament to the strength, ingenuity, and forward-thinking spirit that defines our region.

Congratulations to the entire Regeneron team on this extraordinary accomplishment. Please see the full press release here.