Biohaven's Bipolar Disorder Candidate Fails in Phase 2/3 Trial, Company Advances Other Programs

Biohaven Pharmaceuticals faced a setback in its bipolar disorder program as its lead candidate failed to meet its primary endpoint in a pivotal trial. However, the company continues to advance other promising assets in its pipeline, including a potential breakthrough in autoimmune disease treatment.

BHV-7000 Disappoints in Bipolar I Disorder Study

Biohaven's investigational drug BHV-7000, designed to selectively activate the Kv7.2/Kv7.3 ion channel, failed to demonstrate statistically significant improvement in mania symptoms compared to the comparator in a phase 2/3 trial. The study, which enrolled approximately 250 participants with bipolar I disorder, measured changes in the Young Mania Rating Scale (YMRS) total score over a three-week period.

Despite the setback, Biohaven reported that BHV-7000 was well-tolerated, with no serious treatment-emergent adverse events observed. The company plans to conduct additional analyses and present the full dataset at an upcoming scientific meeting.

The news had an immediate impact on Biohaven's stock, which dropped 14% from $36.95 to $32 at market close on Monday.

Ongoing Development of BHV-7000 and Other Pipeline Assets

While the bipolar disorder trial results were disappointing, Biohaven continues to evaluate BHV-7000 in three other phase 2/3 studies:

1. Major depressive disorder (MDD)
2. Focal epilepsy
3. Generalized epilepsy

Results from the MDD study are expected in the second half of 2025, with focal epilepsy findings anticipated in the first half of 2026. The company is also exploring BHV-7000's potential in pain disorders.

Promising Early Results for BHV-1300 in Graves' Disease

In more positive news, Biohaven reported encouraging phase 1 results for BHV-1300, a subcutaneous small molecule asset being developed for autoimmune diseases. The ongoing study found that a 1000-mg weekly dose of BHV-1300 reduced total IgG by up to 84% in patients with Graves' disease over a four-week period.

The protein degrader, designed to selectively target IgG1, 2, and 4 while sparing IgG3, was reported to be safe and well-tolerated. Biohaven plans to launch a phase 2 trial in Graves' disease by mid-2025 and is considering additional studies in other autoimmune indications.

Dr. Tova Gardin, Biohaven's Chief Translational Officer, highlighted the potential of the company's extracellular degrader technology, stating, "Biohaven's unique extracellular degrader technology leverages the body's natural hepatic clearance mechanism to remove targeted antibodies contributing to disease and promises to usher in a new era of tunable, selective and self-administered immune therapy."