The Phase 3 KINECT‑DCP study of valbenazine in patients with dyskinetic cerebral palsy failed to meet its primary endpoint of reducing chorea and did not achieve the key secondary endpoints. The randomized, double‑blind, placebo‑controlled trial enrolled pediatric and adult patients and ran for 14 weeks, followed by an open‑label extension. The data, released on December 22, 2025, show no statistically significant difference between valbenazine and placebo.
The study enrolled 300 participants across 30 sites, with a 1:1 randomization to valbenazine or placebo. The primary endpoint was the change from baseline in the Unified Dyskinesia Rating Scale (UDRS) chorea subscore at week 14. Secondary endpoints included the UDRS total score, caregiver‑reported quality‑of‑life measures, and safety assessments. The lack of benefit suggests that valbenazine’s mechanism of action, a VMAT2 inhibitor, may not translate to the dystonic and choreiform movements seen in cerebral palsy, or that the dosing regimen was insufficient.
The trial miss comes at a time when Neurocrine’s commercial portfolio remains robust. In the third quarter of 2025, net product sales reached $790 million, driven by $687 million in Ingrezza sales, a 12 % year‑over‑year increase, and $98 million from the newly launched Crenessity. The company reported a cash balance of $2.1 billion as of September 30, 2025, providing a strong financial cushion to absorb the setback.
Chief Medical Officer Sanjay Keswani said the results were disappointing, noting that “there are no approved treatments for people living with dyskinetic cerebral palsy.” He thanked patients, families, investigators, and staff for their participation. CEO Kyle Gano emphasized that the company remains focused on its core products and the broader pipeline, stating that the data will be presented at an upcoming scientific meeting and that the company will evaluate alternative strategies for valbenazine in this indication.
The market reaction to the announcement was muted, with limited volatility in the company’s shares. Analysts have not altered their long‑term outlook, citing the continued strength of Ingrezza and the recent launch of Crenessity as mitigating factors.
While the failure of the KINECT‑DCP trial removes a potential new revenue stream, it does not alter the trajectory of Neurocrine’s flagship products. The company’s diversified pipeline, including late‑stage programs for major depressive disorder and schizophrenia, remains a key driver of future growth. The trial outcome underscores the challenges of translating a drug’s success in one neurological disorder to another, but the company’s financial resilience and ongoing pipeline progress position it to navigate the setback.
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