Neurocrine Biosciences Inc. (NASDAQ:NBIX) on Monday shared data from its Phase 3 KINECT-DCP study evaluating the efficacy, safety, and tolerability of valbenazine in pediatric and adult participants who have dyskinetic cerebral palsy (DCP).
Cerebral palsy (CP) is a nonprogressive neurodevelopmental disorder that affects movement and posture, starting in early childhood. It occurs in about three per 1,000 children in the United States.
People living with dyskinetic cerebral palsy (DCP) often have mixed hyperkinetic movements, including dystonia (sustained or intermittent involuntary muscle contractions) and choreoathetosis (random or writhing involuntary movements), leading to severe motor impairment.
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Phase 3 Results and Primary Endpoint Miss
The trial did not meet primary or key secondary endpoints. The primary objective of the study was to assess improvement in chorea, a type of involuntary movement, in dyskinetic cerebral palsy patients.
Participants aged six to 70 years were randomized to receive either valbenazine or a placebo for 14 weeks.
Following this, participants had the option to enter an open-label extension phase, during which all received valbenazine.
The primary objective for this study is to evaluate the efficacy of valbenazine versus placebo on improving chorea in pediatric and adult subjects who have DCP with choreiform movements.
Adverse events were generally consistent with the established safety profile for valbenazine.
Neurocrine will report the full study results at an upcoming scientific meeting.
Analyst Commentary and Outlook
William Blair said the recent miss is disappointing but does not meaningfully impact its valuation model or investment thesis for Neurocrine.
The firm expects investor focus to remain on execution and commercial performance in 2026, with limited near-term clinical catalysts.
However, analyst Myles R. Minter noted the pipeline positions the company for a longer-term, late-stage, catalyst-rich period, and William Blair reiterated its Outperform rating.
NBIX Price Action: Neurocrine Biosciences shares were down 1.55% at $145.24 during premarket trading on Tuesday, according to Benzinga Pro data.
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