Biohaven’s Troriluzole PDUFA Date Extended by FDA

Biohaven Ltd. ( (BHVN) ) has issued an update.

On May 14, 2025, Biohaven Ltd. announced that the FDA’s Division of Neurology 1 has extended the PDUFA date for the new drug application of troriluzole, intended for the treatment of spinocerebellar ataxia (SCA), by three months. This extension allows for a full review of recent submissions by Biohaven, with the FDA’s decision now expected in the fourth quarter of 2025. Troriluzole, which has been granted Fast-Track, Orphan Drug Designation, and Priority Review, could become the first FDA-approved treatment for SCA, a rare neurodegenerative disease with no current approved therapies. Biohaven’s CEO, Vlad Coric, emphasized the company’s commitment to addressing this unmet medical need, highlighting the drug’s potential to significantly slow disease progression and improve patient outcomes.

The most recent analyst rating on (BHVN) stock is a Buy with a $60.00 price target. To see the full list of analyst forecasts on Biohaven Ltd. stock, see the BHVN Stock Forecast page.

Spark’s Take on BHVN Stock

According to Spark, TipRanks’ AI Analyst, BHVN is a Underperform.

Biohaven Ltd.’s overall stock score is low due to substantial financial challenges, including zero revenue and negative cash flow. Technical analysis indicates bearish momentum, and the valuation is unattractive due to a negative P/E ratio. However, the recent $600 million investment provides a positive outlook by supporting clinical developments. Despite this, the overall risks remain significant, making the stock a cautious investment.

To see Spark’s full report on BHVN stock, click here.

More about Biohaven Ltd.

Biohaven is a biopharmaceutical company focused on the discovery, development, and commercialization of life-changing treatments in key therapeutic areas, including immunology, neuroscience, and oncology. The company is advancing its innovative portfolio of therapeutics, leveraging its proven drug development experience and multiple proprietary drug development platforms.

Average Trading Volume: 1,618,638

Technical Sentiment Signal: Sell

Current Market Cap: $1.99B

For detailed information about BHVN stock, go to TipRanks’ Stock Analysis page.