Biohaven’s pipeline drug BHV-7000 has failed to meet the primary endpoint in a pivotal Phase II/III bipolar trial, sinking the company’s stock price.
The US-based biotech shared the announcement as part of its quarterly earnings release yesterday (3 March), stating that BHV-7000 did not show statistical significance on the primary endpoint of the Young Mania Rating Scale (YMRS). The YMRS is a clinician-administered scale that uses 11 items to assess the patient’s symptoms of mania.
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The Nasdaq-listed company’s stock fell by 13.77%, from $37.18 at market close on 28 February to $32.06 at market close on 3 March.
The Phase II/III registrational study (NCT06419582) enrolled 256 patients across 32 sites who were treated with either BHV-7000 or placebo for 21 days. Further data is due to be presented at an upcoming conference. The company has not confirmed whether it plans to continue investigating the drug as a bipolar treatment.
BHV-7000 75mg once daily, the highest dose being evaluated, was safe and well-tolerated in the study. The company said there were no treatment-emergent serious adverse events (SAEs), with most events being mild in intensity and resolving spontaneously.
Despite the negative readout, all hope is not lost for Biohaven with BHV-7000 as the drug is being evaluated in other studies. These include a Phase II trial (NCT06419608) in major depressive disorder (MDD), focal epilepsy, and generalised epilepsy. Topline results from the MDD study are expected in the second half of 2025, and topline data from the focal epilepsy studies (NCT06309966 and NCT06132893) are expected in early 2026.
Biohaven acquired BHV-7000, a selective activator of Kv7.2/7.3 potassium channels, as part of a February 2022 buyout of Channel Biosciences, a subsidiary of Knopp Biosciences. In October 2022, existing shareholder Pfizer acquired all remaining shares of Biohaven for $11.6bn, which sees the latter to be run as a subsidiary.
GlobalData predicts that, if approved, BHV-7000 will bring in $651m in 2030.
GlobalData is the parent company of Clinical Trials Arena.
In a separate announcement, Biohaven revealed yesterday another pipeline candidate, BHV-1300, an IgG degrader, achieved an 80% reduction in IgG in a Phase I study (ACTRN12624001129572).
