Biohaven stock fell more than 13% in premarket trading as the FDA slapped a partial clinical hold on its Kv7 potassium channel agonist in focal epilepsy. The latest comes days after SK Biopharmaceuticals scored a global license to the Kv7 platform, which encompasses the epilepsy candidate.
It’s also the second regulatory blow to Biohaven in a year. Last November, the FDA rejected the biotech’s product for the treatment of ataxia, a spinocerebellar condition, which resulted in a 60% reduction in the R&D budget. At the time, Biohaven’s stock fell by almost 45% and still has not turned the corner.
SEC Filing Details: Cause for FDA Hold
The partial halt to BHV-7000 (aka opakalim) relates to new patient enrollment in two late-stage focal epilepsy studies. The drug was put on hold for the FDA to evaluate the possible risk to humans from a metabolite that was discovered in rodent trials, Biohaven said in a filing with the SEC. The agency is asking Biohaven to provide more information through additional nonclinical research.
Dosing will continue in all the patients enrolled in the two pivotal trials (RISE 2 and RISE 3) combined, involving more than 600 patients.
The enrollment of patients in RISE 3 was also finished in June, as stated in the same filing, and a “topline data readout” is scheduled to occur in the second half of this year. However, recruiting was not finished for RISE 2. The enrollment pause “is likely to delay the readout of this trial, which will also likely need to read out positively for regulatory approval,” RBC Capital Markets said in a note to investors Thursday morning. The primary completion date for RISE 2 was earlier this year estimated to be in December.
Human Safety Record and Analyst Outlook
“The significance of the nonclinical metabolite findings to humans is uncertain,” Biohaven said in the filing. The results might not be applicable to human safety, and further nonclinical studies are being carried out to help answer that question. In general, BHV-7000 is safe and well tolerated in clinical trials.
To date, more than 1,200 people have been part of studies where they have been given the drug.”
RBC analysts also noted this “comprehensive safety profile,” adding that “If the partial clinical hold is not lifted or nonclinical data is not able to definitively demonstrate that the metabolite does not pose any risk to humans, we believe that BHVN may still be able to potentially rely upon the wealth of human data that they have to reassure regulators that ‘7000 may not pose greater risk to humans.”
This partial halt comes after similar problems faced by Biohaven with the Kv7 asset a few years ago. In December 2025, BHV-7000 failed to improve symptoms in patients with major depressive disorder after six weeks as compared to placebo during a Phase 2 proof-of-concept study.
Mechanism and Therapeutic Potential of the Kv7 Platform
BHV-7000 is the initial asset in Biohaven’s Kv7 platform. According to the company’s website, the asset is a ‘potent, selective activator of Kv7.2/7.3 potassium channels’ that is a validated target in the clinic for regulating the hyperexcitable state as seen in epilepsy. “Increasing evidence also suggests the potential for Kv7.2/7.3 activators to treat neuropsychiatric and pain disorders.”
On Aug. 26, Biohaven Bioscience Ireland Limited signed a worldwide licensing agreement worth up to $795 million with SK Biopharmaceuticals for Biohaven’s Kv7 ion channel platform, including BHV-7000 as well as other Kv7 compounds and products covered by the agreement. “The SEC filing states that all clinical and nonclinical data, such as metabolite characterization submitted to international regulatory authorities, were fully disclosed to SKBP before signing the License Agreement.”
FDA Halts Enrollment in Critical Epilepsy Trials
The U.S. Food and Drug Administration has halted enrollment in critical trials involving a troubled epilepsy medication developed by Biohaven, creating another significant challenge for the company.
The FDA action could affect the development timeline for the epilepsy treatment and may require additional evaluation before new participants can enter the clinical studies. Regulatory decisions of this nature can have major implications for drug developers, particularly when a medicine is being evaluated for patients with serious neurological conditions.
Epilepsy Treatment Development Faces New Challenges
Developing new epilepsy medicines requires extensive clinical testing to assess safety, effectiveness, dosing, and potential risks. Trial enrollment is an important stage because researchers depend on patient participation to generate evidence needed for regulatory decisions.
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
- Editorial Team
