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Praxis Precision Medicines Announces the FDA Has Granted Breakthrough Therapy Designation for Ulixacaltamide HCl in Essential Tremor

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Praxis Precision Medicines Announces the FDA Has Granted Breakthrough Therapy Designation for Ulixacaltamide HCl in Essential Tremor

Praxis Precision Medicines received FDA Breakthrough Therapy Designation for ulixacaltamide, a T-type calcium channel inhibitor for essential tremor treatment, based on positive Phase 3 Essential3 program results. The company plans to submit a New Drug Application (NDA) in early 2026 following a successful pre-NDA meeting with the FDA.

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PRAX   positive

The company received FDA Breakthrough Therapy Designation, which accelerates development and regulatory review. Positive Phase 3 trial results and successful pre-NDA alignment with FDA support faster advancement toward commercialization. The designation addresses a significant unmet medical need in a large patient population (7 million in the US), representing substantial commercial opportunity.