Biohaven Faces Setback in Europe, Withdraws Marketing Application for Spinocerebellar Ataxia Drug

Biohaven Pharmaceutical Holding Company Ltd. has encountered a significant obstacle in its pursuit of European approval for its experimental drug Dazluma, intended to treat spinocerebellar ataxia. The Connecticut-based drug developer withdrew its marketing application from the European Medicines Agency (EMA) on March 24, 2025, following concerns raised by the agency's main drug review committee.

EMA Concerns and Application Withdrawal

The EMA's drug review committee expressed doubts about Dazluma's effectiveness and questioned its classification as a "new active substance." This classification, which comes with substantial commercial benefits, was requested by Biohaven but not convincingly demonstrated according to the committee.

Vlad Coric, CEO of Biohaven, stated in an emailed statement that the company decided to withdraw the application once it became clear that the committee did not intend to grant the new active substance classification. Coric emphasized that Biohaven remains committed to the Dazluma program and plans to resubmit to the EMA later this year after generating additional data to address the classification issue.

Market Reaction and Analyst Perspectives

The news of the withdrawal had an immediate impact on Biohaven's stock, which dropped approximately 16% on Friday, April 25, 2025, trading around $19.50 per share. This decline represents a loss of nearly $400 million in market value for the company.

Charles Duncan, an analyst at Cantor Fitzgerald, characterized the setback as a "speed bump" rather than a "roadblock" for Dazluma's European approval prospects. However, Leonid Timashev of RBC Capital Markets expressed concerns that the European withdrawal might increase the risk associated with the ongoing FDA review in the United States.

Implications for Biohaven's Future

The withdrawal of the European marketing application comes at a crucial time for Biohaven. Since selling its migraine medication portfolio to Pfizer for nearly $12 billion in late 2022, the company has been working to build a diverse research pipeline. This pipeline now includes over a dozen experimental medicines targeting various disease categories, including oncology, immunology, and neuroscience.

However, recent setbacks in clinical testing for some of these medicines have contributed to waning investor confidence. Biohaven's shares have lost approximately two-thirds of their value since peaking at around $58 in March 2024.

As the company awaits an FDA decision on Dazluma, expected between July and September 2025, the pressure continues to mount. Many investors view FDA approval as critical for the stock's recovery, making the upcoming verdict a pivotal moment for Biohaven's future trajectory in the pharmaceutical industry.