Eli Lilly struck deals worth up to $11.55 billion across three acquisitions in two weeks: an up-to-$2.25 billion pact with AI biotech Profluent for genetic medicines, up to $2.3 billion for Ajax Therapeutics and its next-gen JAK2 inhibitor, and up to $7 billion for CAR T-focused Kelonia Therapeutics. Q1 earnings season hasn’t even closed.
FDA cleared Otarmeni, Regeneron’s gene therapy for hearing loss, marking three simultaneous firsts: the first treatment to target an underlying cause of hearing loss, the first gene therapy approval for Regeneron, and the first gene therapy to complete a Phase 1/2 clinical trial without any serious adverse events, according to one of the trial’s investigators. The same day, Regeneron formally signed on to the Trump administration’s Most Favored Nation drug pricing program, becoming the last of the 17 companies that received letters from the White House last summer to do so.
FDA’s standoff with Amgen escalated. The agency has again requested that Amgen pull Tavneos from the market, alleging unblinded study personnel manipulated the pivotal clinical trial results to inflate the autoimmune therapy’s apparent efficacy. Amgen is holding its ground, insisting Tavneos is safe and efficacious.
FDA also issued three Commissioner’s National Priority Vouchers to psychedelic drug developers while withholding their identities from its press release. The agency declined to comment when asked. BioSpace identified the recipients as Compass Pathways, Otsuka (owner of Transcend Therapeutics), and the Usona Institute.
Vinay Prasad departs as CBER director at the end of April. His replacement hasn’t been named.
— Sarah Chen