Praxis Precision Medicines announced that the U.S. Food and Drug Administration has accepted its New Drug Application for ulixacaltamide HCl, a small‑molecule therapy for essential tremor, on April 14 2026. The acceptance places the application in the standard review track, with a Prescription Drug User Fee Act target action date of January 29 2027. The FDA’s decision follows the company’s Phase 3 Essential3 program, which demonstrated statistically and clinically significant improvements in daily functioning for adults with essential tremor. In Study 1, patients achieved a mean improvement of 4.3 points in the mADL11 score at Week 8, meeting the primary endpoint, while Study 2 confirmed sustained efficacy during a withdrawal phase.
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