Biohaven reports Q4 revenue down 17% YoY to $39mln.

• Biohaven Ltd. presents corporate presentation on troriluzole clinical trials. • Data from trials expected to guide regulatory filings and approvals. • Troriluzole has potential in treating various neurological disorders. • Company also developing taldefgrobep alfa, BHV-7000, and other candidates. • Clinical trials underway to evaluate efficacy and safety.

New York, June 4, 2025 - Biohaven Ltd. (NYSE: BHVN) has been the subject of an investigation by Pomerantz LLP, a leading securities litigation firm, following claims of potential securities fraud or unlawful business practices [1]. The investigation, which was announced on June 1, 2025, is ongoing and advises investors to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext. 7980.

The investigation comes amid significant regulatory developments for Biohaven. On May 14, 2025, the company announced that the FDA's Division of Neurology 1 extended the PDUFA date for its troriluzole new drug application (NDA) by three months to facilitate a full review of recent submissions related to information requests from the FDA. This announcement, which was made in a press release, also stated that the Division is planning to hold an advisory committee meeting to discuss the application, but no date has been scheduled. The news resulted in a significant drop in Biohaven's stock price, falling $3.84 per share, or 19.53%, to close at $15.82 per share on May 15, 2025 [1].

Despite the regulatory setback, Biohaven continues to make strides in its clinical pipeline. The company recently initiated a global Phase 2/3 study of BHV-8000, an orally-administered, brain-penetrant, and highly selective TYK2/JAK1 inhibitor, for the treatment of early Parkinson's disease (PD). This pivotal trial, which is a randomized, double-blind, placebo-controlled study, is assessing the efficacy and safety of BHV-8000 at two dose levels relative to placebo [2]. The innovative trial design includes a time-to-event primary endpoint analysis based on significant change in the MDS-UPDRS Part II, which is accepted by the FDA to support registration.

Biohaven's clinical portfolio also includes taldefgrobep alfa (BHV-7000) and other candidates. These developments indicate the company's commitment to advancing neurological treatments, which could potentially guide regulatory filings and approvals in the near future.

References:
[1] https://www.morningstar.com/news/pr-newswire/20250601dc99117/investor-alert-pomerantz-law-firm-investigates-claims-on-behalf-of-investors-of-biohaven-ltd-bhvn
[2] https://www.marketscreener.com/quote/stock/BIOHAVEN-LTD-144171176/news/Biohaven-Ltd-Enrolls-First-Patient-into-Phase-2-3-Trial-in-Early-Parkinson-s-Disease-Targeting-Neu-50102048/