Biohaven Ltd Faces Regulatory Hurdles as FDA Extends Review Period for Troriluzole

In a significant development for Biohaven Ltd, a clinical-stage biopharmaceutical company specializing in neurological and immunoscience diseases, the FDA has extended the review period for its promising drug candidate, troriluzole. This decision has sent Biohaven’s stock into a downward spiral, reflecting investor concerns over the delay in the drug’s potential market entry.

Regulatory Setback for Troriluzole

The FDA’s Division of Neurology 1 has extended the Prescription Drug User Fee Act (PDUFA) date for troriluzole’s new drug application (NDA) by three months, pushing the review deadline to the fourth quarter of 2025. Troriluzole, aimed at treating spinocerebellar ataxia (SCA)—a rare, genetic, and life-threatening neurodegenerative disease—has been granted Fast-Track, Orphan Drug Designation (ODD), and Priority Review by the FDA. Despite these designations, the extended review period has raised concerns about the drug’s timeline to market.

Market Reaction

The news of the FDA’s decision has had an immediate impact on Biohaven’s stock price. As of May 12, 2025, Biohaven closed at $19.51, a significant drop from its 52-week high of $55.7 on October 7, 2024. The market cap stands at approximately $2.07 billion, reflecting the volatility and investor apprehension surrounding the company’s future prospects.

Financial Performance

In its first quarter of 2025, Biohaven reported a non-GAAP earnings per share (EPS) of -$1.64, missing expectations by $0.17. This financial performance, coupled with the regulatory setback, has led to a downward revision of the company’s target price by RBC Capital, further dampening investor sentiment.

Looking Ahead

Despite the current challenges, Biohaven remains committed to advancing its pipeline of therapies for neurological and immunoscience diseases. The company continues to serve its customers in the United States and maintains its presence on the New York Stock Exchange. As Biohaven navigates this regulatory hurdle, investors and stakeholders will be closely monitoring the FDA’s review process and the company’s strategic responses to ensure the successful development and commercialization of troriluzole.

In conclusion, while the FDA’s extension of the review period for troriluzole presents a significant challenge for Biohaven, the company’s focus on innovative therapies for underserved medical conditions positions it as a key player in the biopharmaceutical industry. The coming months will be crucial as Biohaven works to address regulatory concerns and move forward with its mission to alter current treatment paradigms for neurological and immunoscience diseases.