The drug treats hyperphagia, the hallmark symptom of Prader-Willi syndrome, a genetic disorder caused by full or partial deletions on chromosome 15 that affect the regulation of gene expression, or how genes turn on and off.
The organizations, however, emphasized that the reports do not establish a causal link between Vykat XR and the adverse outcomes.
FDA database shows four deaths related to the drug.
Company response and portfolio context
Neurocrine added Vykat XR to its portfolio earlier this year through its $2.9 billion acquisition of Soleno Therapeutics.
Neurocrine said it is "engaged with the FDA, patient advocacy communities and prescribers to continue to assess all available data from postmarketing surveillance as the prescribing population expands".
As of last close, the stock was up 14.2% year to date.
Shares fall after joint statement on Vykat XR
Shares of drugmaker Neurocrine Biosciences (NBIX.O) fell 3.1% to $156.88.
Three organizations issued a joint statement on Tuesday citing post-marketing reports of seven deaths and more than 100 reports of serious adverse events in patients receiving NBIX's drug Vykat XR, which was approved in March 2025.
NBIX•
