Biohaven Ltd. Faces Challenges as FDA Delays Decision on Key Drug

Biohaven Ltd., a clinical-stage biopharmaceutical company based in New Haven, United States, experienced a significant drop in its stock price on May 15, 2025, following unexpected developments from the U.S. Food and Drug Administration (FDA). The company, which specializes in developing therapies for neurological and immunoscience diseases, saw its shares plunge due to a surprise twist in the FDA’s review process for its rare-disease drug, troriluzole.

FDA Extends Review Period for Troriluzole

Multiple sources, including Investors.com, Yahoo Finance, and Seeking Alpha, reported that the FDA has extended the review period for troriluzole, a drug intended to treat spinocerebellar ataxia (SCA), a rare and life-threatening neurodegenerative disease. The extension was confirmed by the Division of Neurology 1 within the FDA’s Office of Neuroscience, which pushed back the Prescription Drug User Fee Act (PDUFA) date by three months to the fourth quarter of 2025. This decision was also highlighted by Nasdaq and Finviz, emphasizing the impact on Biohaven’s market position.

Impact on Biohaven’s Financials

The delay in the FDA’s decision has had a notable impact on Biohaven’s financial standing. The company’s stock closed at $19.51 on May 12, 2025, significantly lower than its 52-week high of $55.7 on October 7, 2024, and closer to its 52-week low of $15.79 on April 8, 2025. The market capitalization of Biohaven stands at approximately $2.07 billion.

In its first-quarter financial results released on May 12, 2025, Biohaven reported a non-GAAP earnings per share (EPS) of -$1.64, missing expectations by $0.17. This financial performance, coupled with the FDA’s decision, has led to a reassessment of the company’s target price by RBC Capital, as reported by Feedburner.

Troriluzole’s Significance

Troriluzole, which has been granted Fast-Track, Orphan Drug Designation (ODD), and Priority Review by the FDA, is poised to be the first treatment for SCA. The extension of the PDUFA date allows the FDA additional time to review recent safety data, which is crucial for the drug’s approval process.

Conclusion

Biohaven Ltd. continues to navigate the challenges posed by regulatory hurdles as it seeks to bring innovative treatments to market. The extended review period for troriluzole underscores the complexities of drug development, particularly for rare diseases, and highlights the importance of regulatory compliance in the biopharmaceutical industry. Investors and stakeholders will be closely monitoring the FDA’s next steps as Biohaven works towards potentially altering treatment paradigms for neurological and immunoscience diseases.