Neurocrine Biosciences, Inc. (NBIX), on Monday reported that its subsidiary Soleno Therapeutics presented late-breaking data from the Phase 3 extension study for VYKAT XR in treating Prader-Willi syndrome (PWS). The company presented these results at the 2026 Endocrine Society's Annual Meeting (ENDO) in Chicago, Illinois.
VYKAT XR (diazoxide choline) is an extended-release prescription tablet, previously approved in 2025 by the U.S. Food and Drug Administration (FDA) for the treatment of hyperphagia in patients with PWS.
Prader-Willi syndrome (PWS) is a rare genetic neurodevelopmental disorder caused by abnormalities in gene expression on chromosome 15. The defining symptom of PWS is hyperphagia, a chronic and life-threatening condition marked by a persistent hunger sensation accompanied by food preoccupations and food-related behavior problems. According to the Prader-Willi Syndrome Association USA, estimates are one in every 15,000 live births is reported to have PWS.
C614 was a Phase 3 VYKAT XR extension, open-label study that was conducted on 77 patients after a 16-week, double-blind, placebo-controlled, randomized withdrawal period.
The study evaluated whether participants who switched to placebo during the withdrawal period regained treatment benefit after resuming VYKAT XR and whether those who continued the treatment maintained durable benefits over time.
The study reported participants who resumed VYKAT XR treatment after the withdrawal period demonstrated durable improvements in hyperphagia, assessed using the Hyperphagia Questionnaire for Clinical Trials (HQ-CT), and behavioral symptoms, measured using the PWS Profile questionnaire (PWSP), with benefits continuing through 2 years. The BMI of patients also remained relatively stable.
NBIX closed Monday's trade at $159.51, down 0.16%. In the pre-market, shares are trading at $159.60, up 0.06%.
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