Regeneron's Gene Therapy For Genetic Hearing Loss Gets Accelerated FDA Nod — Drug Pricing Deal With White House To Be Announced Today

• Regeneron stated that Otarmeni is now the first and only FDA-approved gene therapy to restore a neurosensory function to normal levels.
• Otarmeni is Regeneron’s first approved gene therapy, but its continued approval hinges on demonstrating clinical benefit in the confirmatory phase of the CHORD trial, the company said.
• According to a report, Regeneron will also list its cholesterol-lowering drug, Praluent, on the TrumpRx website.

Regeneron Pharmaceuticals Inc. (REGN) on Thursday announced that its gene therapy for genetic hearing loss, Otarmeni, has received accelerated approval from the U.S. Food and Drug Administration (FDA).

The company stated that it will offer Otarmeni free of charge to eligible individuals in the U.S.

Meanwhile, White House Press Secretary Karoline Leavitt stated in a post on X that the Trump administration will announce a deal with Regeneron on Thursday.

Regeneron is only one of the 17 pharmaceutical companies to have not yet agreed to lower U.S. drug prices following letters sent by the Trump administration in July 2025.

Regeneron shares were up more than 2% in Thursday’s midday trade.

First Gene Therapy Approval For Genetic Hearing Loss

Regeneron stated that Otarmeni is now the first and only FDA-approved gene therapy to restore a neurosensory function to normal levels.

The company stated that Otarmeni was approved based on the results of the CHORD trial, which demonstrated that 80% of participants met or exceeded the primary endpoint and that a longer follow-up was required. Regeneron stated that 42% of participants achieved normal hearing, including the ability to hear whispers.

Otarmeni is a gene therapy that uses an adeno-associated virus to treat children and adults with severe-to-profound hearing loss caused by confirmed mutations in the OTOF gene, provided they still have functioning outer hair cells and have not received a cochlear implant in the affected ear.

Otarmeni is Regeneron’s first approved gene therapy, but its continued approval hinges on demonstrating clinical benefit in the confirmatory phase of the CHORD trial, the company said.

Regeneron To List Cholesterol Drug On TrumpRx, Says Report

According to a report by NOTUS reposted by Leavitt, Regeneron will also list its cholesterol-lowering drug on the TrumpRx website.

The report noted that Regeneron will sell Praluent on the TrumpRx portal for $225.

It also states that President Donald Trump is scheduled to make the announcement on Thursday afternoon. The announcement will feature a mother whose child regained hearing after using Regeneron’s Otarmeni.

Regeneron stated that while its hearing loss therapy will be provided free of charge, the administration cost depends on the healthcare provider.

REGN stock is down 1% year-to-date, but up 30% over the past 12 months. The S&P 500 ETF (SPY) is up 33% over the past 12 months, while the Invesco QQQ Trust (QQQ) is up 33%.

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