Patient advocates and some experts are raising renewed safety alarm around Neurocrine Biosciences’ rare-disease therapy Vykat XR (for Prader-Willi syndrome). A STAT+ follow-up reports growing concern after an open letter cited potential safety issues tied to the drug, including deaths and hospitalizations reported since approval. The reports note that available case details—obtained via regulatory submissions through the Freedom of Information Act—do not prove causality on their own, but experts say the accumulating evidence may be enough to conclude unacceptable harm. In a separate regulatory milestone, Asahi Kasei Therapeutics secured FDA approval for Hovilpri, a new oral treatment for herpes simplex virus lesions acquired earlier this year. The clearance adds to the after-acquisition momentum for approved antiviral assets in the U.S.