FDA cleared Otarmeni, Regeneron’s hearing loss gene therapy, on Thursday, the same day the pharma ended nearly nine months of resistance and agreed to Most Favored Nation pricing with the Trump administration.
Otarmeni targets congenital deafness caused by otoferlin protein deficiency and is the first FDA-approved medicine to address an underlying cause of deafness. Phase 1/2 CHORD study data showed 11 of 12 pediatric patients achieved clinically meaningful hearing improvements; three reached normal hearing levels. It’s also Regeneron’s first gene therapy. Under the pricing deal, the company will provide Otarmeni free in the U.S.
The MFN agreement covers Praluent, Regeneron’s cholesterol drug, which will be listed on TrumpRx, the government’s direct-to-consumer platform. Regeneron also committed to unspecified R&D and manufacturing investments in the U.S. In exchange, the company secured a three-year exemption from tariffs and future pricing mandates, a key provision after Trump imposed a 100% levy on imports of patented pharmaceutical products and ingredients on April 3.
Truist Securities called the deal “welcome,” noting it removes “tail risk” from holding out. BMO Capital Markets added that Praluent revenues are “a small fraction” of Regeneron’s top line, so the earnings impact will be incremental.
With Regeneron signed, every Big Pharma has now agreed to MFN pricing. But Pfizer’s experience warns against complacency: it was the first company to the White House with an MFN deal and didn’t end up on the tariff exemption list. Three-year clock starts now.
Sarah Chen