Praxis Precision Medicines reported positive results from two Phase 3 studies of ulixacaltamide in essential tremor, meeting primary endpoints and supporting a planned new drug application in early 2026. The company said one trial met its modified activities-of-daily-living endpoint and a randomized-withdrawal study confirmed maintenance of effect; enrollment exceeded expectations for a disorder with few effective options. Investors reacted strongly—shares surged on the readouts—and company leadership outlined regulatory timelines for an NDA. The programs’ scale (hundreds of patients) and consistent safety profile underpin Praxis’s filing strategy. If approved, ulixacaltamide would be among the first new oral therapies specifically approved for essential tremor in decades, potentially changing standards of care and opening a sizable commercial opportunity.
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