FDA extends its review of Capricor Therapeutics’ Duchenne muscular dystrophy cell therapy as an unhappy shareholder advocates for change; Merck and Moderna tout positive data for their mRNA-based cancer vaccine; Trump nominates White House aide Heidi Overton as FDA commissioner; and the oral obesity market heats up with rivals Eli Lilly and Novo Nordisk going head-to-head.
Capricor Therapeutics has been trying to get its cell therapy for Duchenne muscular dystrophy across the finish line since last year, when it received its first rejection. The company resubmitted its application and the FDA accepted the application, with a PDUFA date this past weekend. That date came and went before the FDA granted a three-month extension. The extra time follows a contentious advisory committee meeting that could have implications for the broader industry. Meanwhile, Capricor has paused all other pipeline projects as it focuses on getting deramiocel across the regulatory finish line—a decision at least one shareholder is none too pleased with.
Elsewhere, Moderna released promising Phase 3 results for its Merck-partnered personalized mRNA-based cancer vaccine, being trialed in combination with Keytruda for melanoma. The readout was highly anticipated and came ahead of schedule, nearly doubling Moderna’s stock the morning of the announcement. Merck will also benefit from continued good news around the program as it stares down the loss of Keytruda exclusivity.
Over at the FDA, we finally have Trump’s next nominee for a permanent leader: White House aide Heidi Overton. Current Deputy Director of the White House Domestic Policy Council, Overton has a medical degree from the University of New Mexico, completed a surgical residency in general surgery at Johns Hopkins and has a PhD in clinical investigation from Hopkins’ Bloomberg School of Public Health. Analysts say she could be good for psychedelics and new pain meds but bad for vaccines.
Finally, the oral obesity space is heating up as rivals Novo Nordisk and Eli Lilly fight for marketshare. Novo’s oral Wegovy has clearly outpaced Foundayo so far, a lead analysts have attributed in part to the drug’s name recognition. By contrast, Lilly’s pill is an entirely separate offering from its GLP-1 injectable Zepbound. Will Novo be able to retain its lead?
In one attempt to do so, the Danish pharma announced last week that it’s launching a Phase 3 study to determine an optimal lower starting dose of the Wegovy pill. Lilly, meanwhile, officially launched Foundayo in the U.K. this week—a market where analysts say the Indianapolis pharma may have an easier time thanks due to the high margins of a small-molecule therapy.” Novo’s Wegovy pill, by contrast, is a peptide that is harder and more expensive to manufacture.
In the meantime, there are plenty of other companies hoping to break the Novo-Lilly weight loss duopoly. One of those with a pill—and a recent readout—is Enveda, which has been advertising its investigational asset as “exercise in a tablet.”
