Biohaven Stock Surges on FDA Review of Vyglxia

This development marks a significant shift for the New Haven-based firm following the FDA’s initial rejection of the drug in November 2025. The company’s latest filing incorporates fresh supportive analyses, which the agency now deems a complete response to its previous concerns.

Regulators have established a target action date for the application in the first quarter of 2027. Biohaven expects the agency to convene an advisory committee to further evaluate the clinical data, with details on the meeting schedule forthcoming. Spinocerebellar ataxia remains a severe, life-threatening diagnosis, causing the rapid degradation of motor control and the physical atrophy of the brainstem and cerebellum.