STAT+: Vertex stem cell therapy spurs insulin independence

Good morning! Today, we get deeper into the ousting of Nicole Verdun at the FDA, see promise from Vertex’s cell therapy for diabetes, and unpack the story of developing the newly approved Gilead PrEP drug lenacapivir.

The need-to-know this morning

• Novo Nordisk terminated its marketing relationship with Hims & Hers, accusing the telehealth company of deceptive marketing practices and selling “illegitimate” compounded versions of the weight-loss drug Wegovy. 
• Compass Pathways reported results from a Phase 3 study of its psilocybin-based drug for treatment-resistant depression.

FDA ouster tied to Duchenne therapy clash

The sudden removal of Nicole Verdun, the FDA’s top cell and gene therapy regulator, followed a dispute with her boss, Vinay Prasad, over holding a public advisory committee meeting on a cell therapy for Duchenne muscular dystrophy made by Capricor Therapeutics, STAT reports. Prasad unilaterally canceled the meeting, escalating internal tensions and leading to Verdun and her deputy being placed on administrative leave and escorted out of FDA headquarters — an unusually harsh move that stunned agency staff and industry alike.

Though Verdun faced management complaints, she was widely respected for balancing urgency with rigor. The shakeup comes amid mounting concern over inconsistent regulatory standards for high-stakes gene therapies. Notably, multiple agency employees have told STAT that Prasad is uninterested in the administrative aspects of running CBER — meaning that more expert managers in the department are critical.

Continue to STAT+ to read the full story…