Biohaven Faces Share Price Decline Amid FDA Delay
Biotech stock Biohaven, known for its volatility, experienced a significant decline on Thursday as its share price dropped nearly 20% following a development with a major regulatory body. This occurred on a day when the overall market performed well, with the S&P 500 rising by 0.4%.
FDA Extends Decision Timeline
After the market closed on Wednesday, Biohaven announced that the U.S. Food and Drug Administration’s Division of Neurology 1 decided to extend the timeline for a decision on a promising drug in the company’s pipeline. The FDA is prolonging the Prescription Drug User Fee Act (PDUFA) date for troriluzole, a treatment targeting spinocerebellar ataxia (SCA), by three months. Biohaven, which has submitted troriluzole under the New Drug Application (NDA) regime, now anticipates a decision in the fourth quarter of this year.
The company reported that the FDA requires additional time for a comprehensive review of recent submissions. The FDA also plans to hold an advisory committee meeting to discuss the troriluzole application, although no date has been set.
Awaiting Further FDA Actions
Troriluzole is considered to have significant potential, targeting a rare brain disorder with no current treatment. It has received fast-track, priority review, and orphan drug designation from the FDA, initially suggesting an imminent approval decision. However, the delay has introduced uncertainty, with the future of troriluzole largely dependent on forthcoming FDA actions.
