Praxis Precision Medicines Inc.
Praxis Precision Medicines Announces Positive Topline Results for Ulixacaltamide in Essential Tremor
Summary
Praxis Precision Medicines, Inc. announced positive topline results from its Phase 3 Essential3 program of ulixacaltamide for essential tremor (ET). Both Study 1 and Study 2 met their primary endpoints, with statistically significant improvements in mADL11 scores at Week 8 and sustained efficacy throughout the treatment period. The most common treatment-emergent adverse events were constipation, dizziness, euphoric mood, brain fog, headache, paraesthesia, and insomnia, with no drug-related serious adverse events. The Company has submitted a pre-NDA meeting request to the FDA and plans to submit the NDA by early 2026.
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About Praxis Precision Medicines Inc.
Praxis Precision Medicines Inc. operates within the biopharmaceutical sector, focusing on the development of treatments for central nervous system (CNS) disorders. The company's primary objective is to address unmet medical needs by leveraging their extensive research in genetics, the neurobiology of CNS disorders, and translational science. Praxis Precision Medicines is rapidly carving out a niche in the healthcare field by targeting illnesses such as epilepsy, movement disorders, and psychiatric conditions, which impact millions of individuals globally. Their innovative pipeline includes a variety of therapeutic candidates designed to modulate specific neural pathways that are believed to be core to CNS dysregulation. As an emerging leader in the biopharma industry, Praxis Precision Medicines plays a crucial role in advancing CNS treatment paradigms, working to improve quality of life for patients and expand the possibilities of personalized medicine through cutting-edge science.
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