FDA panel rejects Duchenne drug; FTC sues Hims & Hers over data practices

A U.S. Food and Drug Administration advisory panel voted 9-to-3 to reject Capricor Therapeutics' candidate for Duchenne muscular dystrophy, focusing on its inability to prove benefit for Duchenne-related cardiomyopathy. The panel highlighted that the company altered its statistical analysis plan in ways that reduced the robustness of the results, making positive signals hard to interpret. This decision follows the agency’s earlier refusal to approve the drug and its request for additional data.

In a separate action, the Federal Trade Commission, together with the states of Utah and California, sued digital health firm Hims & Hers, alleging deceptive practices around the collection and sharing of sensitive health information, opaque subscription renewals, and insufficient opportunities for patients to review or consent to provider recommendations. The lawsuit further claims the company obstructs users from canceling their recurring subscriptions. Both developments underscore heightened regulatory scrutiny of emerging medical therapies and online health-service business models.