Praxis Precision Medicines paused enrollment in its POWER2 phase 3 study of vormatrigine after the drug missed the primary endpoint in the POWER1 phase 2/3 trial for focal onset seizures (FOS). POWER1 failed to show a reduction in monthly seizure frequency versus baseline, though Praxis pointed to a 50% response rate signal and a stronger effect in the 30 mg dose arm. Praxis said less than 10% of patients discontinued due to adverse events and added that it will reassess the vormatrigine program for potential modifications while continuing preparation for relutrigine and ulixacaltamide launches. The FDA is due in September on relutrigine and in January 2027 on ulixacaltamide, both sodium- and T-type channel approaches in epilepsy. The pause matters because it changes the near-term probability of a registrational path for vormatrigine, even as Praxis tries to preserve momentum across its broader sodium-channel and calcium-channel pipeline.
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