Praxis Precision Medicines, Inc. announced positive topline results from its Phase 3 Essential3 program evaluating ulixacaltamide for essential tremor (ET), the most movement disorder.
Praxis stock significantly hiked to 130% in premarket trading following the news.
In Study 1, patients who were administered ulixacaltamide showed a mean 4.3-point enhancement in the Modified Activities of Daily Living 11 (mADL11) score at Week 8.
Study 2 met its primary endpoint, showing greater maintenance of effect vs. placebo during the randomized-withdrawal phase. The first key secondary endpoint also favored ulixacaltamide.
Ulixacaltamide was acceptable with a safety profile consistent with earlier studies and no side effects. Praxis plans to hold a pre-NDA meeting with the FDA before a new drug application (NDA) submission in early 2026.
CEO Marcio Souza said it is a major step forward for patients living with essential tremor (ET), while investigator Dr. Salima Brillman called the therapy as “a real opportunity to help people regain their independence.”
