Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) has reached an agreement with the U.S. government to lower drug prices, expand patient access, and provide a newly approved gene therapy at no cost, aligning with policy priorities outlined by Donald Trump.

The deal, announced Thursday, follows discussions at the White House involving Regeneron co-founders Leonard Schleifer and George Yancopoulos, and addresses pricing, accessibility, and domestic investment commitments.

Pricing Alignment And Direct Access Initiatives

Under the agreement, Regeneron will tie Medicaid drug pricing to benchmarks in other developed countries and align future U.S. medicine prices with those international levels.

The company will also make its cholesterol-lowering drug Praluent (alirocumab) available for direct purchase through TrumpRx.gov at a most-favored-nation price, potentially bypassing traditional distribution channels for eligible patients.

Free Gene Therapy For Rare Hearing Loss

Regeneron said it will provide Otarmeni (lunsotogene parvec-cwha) free of charge in the U.S.

The therapy on Thursday received accelerated approval from the U.S. Food and Drug Administration and targets an ultra-rare form of genetic hearing loss caused by OTOF gene variants.

The approval comes as part of the FDA's Commissioner's National Priority Voucher (CNPV) process.

Otarmeni is the first in vivo gene therapy for this condition and marks Regeneron's entry into approved genetic medicines.

Regeneron added the hearing loss gene therapy via the Decibel Therapeutics deal at $109 million.

Clinical Data And Unmet Need

Approval was based on results from the CHORD trial, where 80% of participants met the primary endpoint for improved hearing, and 42% achieved normal hearing levels over time, including the ability to detect whispers.

The condition affects roughly 50 newborns annually in the U.S. and has historically been managed with assistive devices rather than curative treatments.

Investment Commitments And Policy Tradeoffs

As part of the agreement, Regeneron will continue investing heavily in U.S.-based research, development, and manufacturing, with more than $9 billion already committed.

In return, the company will avoid future pricing mandates and receive three years of tariff relief under a Department of Commerce arrangement. Additional terms of the agreement were not disclosed.

REGN Price Action: Regeneron Pharmaceuticals shares were down 2.89% at $743.86 at the time of publication on Friday, according to Benzinga Pro data.

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