FDA Pauses New Enrollment in Biohaven's Epilepsy Trials, Not the Patients Already in Them
The U.S. Food and Drug Administration has told Biohaven to stop enrolling new patients in its late-stage trials of the epilepsy drug BHV-7000, according to a filing by the company. The hold applies to new enrollment only: dosing continues for the more than 600 patients already randomized across the program.
BHV-7000 is being tested in adults with refractory focal epilepsy, seizures that begin in one part of the brain and that existing medicines do not control. Biohaven's Form 8-K says the agency issued the partial clinical hold letter on Sept. 4, 2026. New enrollment is paused until the company finishes further animal studies of one substance the drug breaks down into, a metabolite observed in rodent testing.
The filing says there was not enough information about that specific metabolite to assess its risk to human subjects, and that the FDA then instructed the company to pause enrollment. Biohaven says the significance of the rodent findings for humans is uncertain, that they may be specific to rodents, and that the additional studies now underway are meant to settle the question. It expects the data in the coming weeks.
One of the two pivotal trials, BHV7000-303, finished enrolling in June 2026 and is unaffected. Dosing continues there, and Biohaven says its first results remain on schedule for the second half of 2026. The other pivotal trial, BHV7000-302, continues dosing the patients it has but may not add more, as does an extension study that keeps earlier participants on the drug. Biohaven extended the pause voluntarily to its sites outside the United States.
Biohaven says more than 1,200 people have taken BHV-7000 across the program and calls its clinical safety record so far generally safe and well tolerated. The filing was signed on Sept. 9 by chief financial officer Matthew Buten. It also records that a Biohaven subsidiary agreed on Aug. 26 to license the company's Kv7 drug platform, BHV-7000 included, to SK Biopharmaceuticals. All of the metabolite data submitted to regulators was disclosed to SK Biopharmaceuticals before signing.
