Neurocrine launches new safety study after another death linked to Prader-Willi drug Vykat

Neurocrine Biosciences announced it will start a new study to evaluate dosing and safety of its rare disease drug Vykat in patients with Prader-Willi syndrome who have complex health issues.

The move follows a recently reported patient death after taking Vykat, a case that was raised during Neurocrine's third‑quarter earnings call and prompted analyst inquiries.

Vykat received FDA approval in 2025 after Neurocrine acquired Soleno Therapeutics in April as part of a $2.9 billion transaction.

The company reiterated confidence in the drug's benefit‑risk profile, emphasizing that the FDA‑approved label provides clear guidance and that careful patient selection and monitoring are essential.

Clinicians and patient‑advocacy groups have voiced concerns about safety events, and the upcoming study aims to address dosing and safety uncertainties for this vulnerable population.