Biohaven: Despite Delay, FDA Review for Troriluzole Program on Track for Q4 2025

Biohaven Pharmaceuticals' Troriluzole program has been delayed, but the FDA review remains on track for Q4 2025. Despite the setback, Biohaven is focusing on other programs, including its Phase 2 trial for the treatment of spinocerebellar ataxia (SCA). The company is also exploring strategic partnerships to accelerate its growth.

Biohaven Pharmaceuticals (BHVN) has experienced a setback with its troriluzole program, but the FDA review remains on schedule for the fourth quarter of 2025. The company's drug, troriluzole, was initially expected to be reviewed by the FDA in the third quarter of 2025. However, in May 2025, the FDA's Division of Neurology 1 extended the review date by three months and planned an advisory committee meeting for review [1].

Despite the delay, Biohaven's troriluzole program for the treatment of spinocerebellar ataxia (SCA) remains on track. The company's New Drug Application (NDA) for troriluzole was submitted in the fourth quarter of 2024 under Priority Review. The drug demonstrated a clinically meaningful slowing of disease progression in pivotal study BHV4157-206-RWE, with results showing a 50% to 70% reduction compared to external control studies [1].

In a positive development, the FDA informed Biohaven that an advisory committee meeting would no longer be required for the review. This increases the likelihood of FDA approval but does not guarantee it [1]. The company's financials as of June 30, 2025, show cash, cash equivalents, and marketable securities totaling $408.2 million, with additional funding options available [1].

Biohaven is also focusing on other programs, including its Phase 2 trial for SCA and exploring strategic partnerships to accelerate its growth. The company's Kv7 activator, BHV-7000, is expected to release pivotal topline results for major depressive disorder (MDD) and focal epilepsy in the second half of 2025 and the first half of 2026, respectively [1].

Investors should be aware of the risks associated with the ongoing Priority Review PDUFA of troriluzole and the clinical development of BHV-7000. The FDA's consideration of external controls and the potential for the primary efficacy endpoints to be met in a statistically significant manner are key uncertainties [1].

References:
[1] https://seekingalpha.com/article/4816367-biohaven-despite-troriluzole-delay-fda-review-on-track