Regeneron Closes MFN Deal; Offers Gene Therapy Free

• Regeneron becomes the 17th and final company to sign an MFN pricing deal with the Trump administration, covering 86% of the branded drug market
• The agreement includes a 58% price cut on the cholesterol drug Praluent and free access to the newly FDA-approved gene therapy Otarmeni

Regeneron has agreed a Most Favored Nation (MFN) drug pricing deal with the White House, becoming the 17th and final company in the Trump administration’s targeted round of pharmaceutical pricing negotiations. The agreement, announced April 23, 2026, covers Medicaid pricing on current and future Regeneron medicines, and includes a commitment to offer the company’s newly approved gene therapy for inherited deafness at no cost to U.S. patients.

Praluent Price Cut and TrumpRx Access

Under the terms of the deal, Regeneron will reduce the list price of its PCSK9 inhibitor Praluent (alirocumab) from $537 to $225 for patients purchasing directly through TrumpRx.gov, the administration’s direct-to-consumer drug purchasing portal. All new Regeneron medicines will be priced in line with MFN levels, defined as the lowest prices paid for comparable drugs in other developed nations. In exchange, Regeneron receives a three-year exemption from the administration’s pharmaceutical tariffs and immunity from future pricing mandates, according to the company.

First Gene Therapy for Genetic Hearing Loss Approved, Offered Free

Coinciding with the pricing announcement, the FDA approved Otarmeni (lunsotogene parvec-cwha), Regeneron’s gene therapy for a rare form of inherited deafness caused by mutations in the OTOF gene. The therapy received authorization under the FDA Commissioner’s National Priority Voucher Program, an expedited review pathway for products aligned with identified national priorities. Regeneron has committed to making Otarmeni available at no cost to eligible U.S. patients. The condition affects an estimated 20 to 50 newborns per year in the U.S.

$27 Billion U.S. Manufacturing Commitment

As part of the agreement, Regeneron has pledged $27 billion in U.S. research, development, and manufacturing investment by 2029 — a commitment the White House says will more than double the company’s domestic biologic manufacturing capacity. Regeneron noted it has already committed more than $9 billion in U.S. manufacturing and R&D investments in the coming years, including a $3 billion commercial manufacturing agreement with CDMO Fujifilm Biotechnologies in North Carolina and approximately $2 billion earmarked for a production site in Saratoga Springs, New York.

17-Company MFN Round Now Complete

The Regeneron deal closes the administration’s initial round of MFN negotiations. The 17 companies — which now include Pfizer, AstraZeneca, Eli Lilly, Novo Nordisk, Amgen, Bristol Myers Squibb, Boehringer Ingelheim, Genentech, Gilead Sciences, GSK, Merck, Novartis, Sanofi, Johnson & Johnson, AbbVie, EMD Serono, and Regeneron — collectively represent 86% of the branded U.S. drug market, according to Chris Klomp, chief counselor of the Department of Health and Human Services. Pfizer was the first to sign, in September 2025; AbbVie and J&J preceded Regeneron in the most recent round. Concerns have been raised by lawmakers and patient advocacy groups about the transparency of deal terms, with Democratic Sen. Ron Wyden sending letters to 11 manufacturers in March requesting clarification on which specific drugs are covered and what state Medicaid programs are expected to pay.

Regeneron co-founder and CEO Leonard Schleifer, M.D., Ph.D., said the agreement addresses a long-standing imbalance in how innovation costs are distributed globally. “For too long, American patients and taxpayers have shouldered a disproportionate share of the cost of biotechnology innovation,” Schleifer said in a statement, adding that the company has argued for over a decade that meaningful relief for U.S. patients depends on other high-income nations contributing their fair share.