By Christy Santhosh
Dec 24 (Reuters) – Biohaven said on Wednesday its experimental depression drug did not meet the main goal of a mid-stage trial, adding to a string of trial and regulatory setbacks for the drugmaker this year.
The company’s shares fell 17% in extended trading and are down more than 70% this year, weighed down by a clinical trial failure in March and the U.S. health regulator’s rejection of its drug troriluzole for a rare neurodegenerative disorder.
Biohaven’s drug, BHV-7000, when tested in patients with major depressive disorder in a six-week trial did not show significant reduction in depressive symptoms compared with placebo as measured by change in the Montgomery Asberg Depression Rating Scale.
The company considers the depression subgroup analyses as “hypothesis generating” but does not plan on additional psychiatric clinical trials to keep resources focused on key priority areas of immunology, obesity and epilepsy in 2026.
RBC Capital Markets analyst Leonid Timashev said the trial miss is “not surprising” given the limited clinical efficacy data to date and MDD being a challenging indication with significant variability and placebo-effects.
The company is also testing BHV-7000 in epilepsy and has previously evaluated it for bipolar disorder where it failed in a mid to late-stage trial earlier this year.
“With the highest risk events now behind us, we think downside may be somewhat capped by the story refocusing on near-term updates across higher investor interest and greater probability of success programs such as epilepsy,” Timashev said.
Last month, Biohaven said it would cut annual direct R&D spending by about 60% after the U.S. Food and Drug Administration declined to approve its drug troriluzole for spinocerebellar ataxia, a neurodegenerative disorder that affects movement and balance.
(Reporting by Christy Santhosh in Bengaluru; Editing by Shailesh Kuber)
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