Biohaven Ltd. Sees Regulatory Progress and Market Potential Drive Buy Rating

Analyst Myles Minter has maintained a Buy rating for Biohaven Ltd. due to regulatory progress and market potential of troriluzole. The FDA no longer requires an advisory committee meeting, and the drug has a favorable risk/benefit profile, especially for spinocerebellar ataxia. Minter is optimistic about the stock's potential market differentiation. BTIG also maintains a Buy rating with a $60.00 price target.

Biohaven Ltd. (NYSE:BHVN) saw its stock rise by 11.65% to $16.40 premarket on Friday, following significant updates regarding its New Drug Application (NDA) for troriluzole. The drug is being developed for the treatment of adult patients with Spinocerebellar Ataxia (SCA), a rare neurodegenerative disorder.

The FDA's Division of Neurology 1 within the Office of Neuroscience informed Biohaven that it was extending the PDUFA date for the troriluzole NDA by three months to allow for a full review of the company’s recent data submissions. Initially, the FDA had planned to hold an advisory committee meeting to discuss the application. However, in a recent SEC filing, the FDA communicated that it had determined an advisory committee meeting is no longer needed for regulatory decision-making [1].

Troriluzole, if approved, would be the first and only FDA-approved treatment for SCA, which affects approximately 15,000 people in the United States and 24,000 in Europe and the United Kingdom. The drug has shown statistically significant improvements in the f-SARA at years 1 and 2 in a pivotal study [2].

Analyst Myles Minter has maintained a Buy rating for Biohaven due to the regulatory progress and market potential of troriluzole. The FDA’s decision regarding the NDA is expected during the fourth quarter of 2025. BTIG also maintains a Buy rating with a $60.00 price target, citing the potential of the company’s SCA treatment, VYGLXIA [2].

In April, Biohaven announced a $600 million non-dilutive capital agreement with Oberland Capital Management LLC, which is expected to support commercial launch planning in SCA, clinical development activities, and ongoing business operations [1]. Despite facing profitability challenges, Biohaven maintains a solid liquidity position with a current ratio of 3.82x [2].

References:
[1] https://finance.yahoo.com/news/biohaven-advances-toward-potential-first-131412222.html
[2] https://www.investing.com/news/sec-filings/biohaven-says-fda-will-not-hold-advisory-meeting-for-troriluzole-application-93CH-4206547