Praxis Precision Medicines reported that ulixacaltamide met primary endpoints in two Phase 3 trials, delivering a decisive clinical win for an essential tremor therapy. The company said treated patients showed statistically significant functional improvement and maintenance of effect versus placebo, and management signaled plans to prepare an NDA in early 2026. The trials enrolled several hundred patients across randomized and randomized-withdrawal stages; regulators and investors will now focus on safety datasets and labeling strategy. The outcome reverses a prior interim concern that had clouded the program and sent shares swinging; market reaction was immediate. Praxis’ results stand to make ulixacaltamide the first approved targeted oral therapy for essential tremor if regulators concur on clinical meaningfulness. Sponsors and regulators will evaluate the breadth of responder analyses and durability of effect across subgroups to determine whether expedited reviews or advisory input are appropriate. For drug developers, the program demonstrates the value of sustained Phase 3 execution after rocky interim reads. Payers and clinicians will watch the company’s next steps on filing strategy, real-world uptake modeling, and comparative-effectiveness messaging versus off-label standards of care.