STAT reported escalating safety concerns tied to Neurocrine Biosciences’ Vykat XR, a Prader-Willi syndrome therapy. Patient advocates and some experts are raising alarms after seven reported deaths and nearly 100 hospitalizations following approval 18 months ago. The report notes that case reports alone do not establish causality, and some events may involve complex comorbid medication histories. Still, the FOIA-obtained regulator submissions and the volume of serious outcomes are being interpreted by experts as sufficient to justify closer review. For the biotech community, the development highlights how real-world pharmacovigilance narratives can rapidly become regulatory and litigation-adjacent pressure points. It also underscores the need for companies to be prepared to respond to safety signals with structured causality assessments and robust post-authorization monitoring.