Praxis Precision Medicines Inc.
12/29/2025 | Press release | Distributed by Public on 12/29/2025 07:05
Material Event (Form 8-K)
Item 8.01. Other Events.
On December 29, 2025, Praxis Precision Medicines, Inc. (the "Company") announced that the U.S. Food and Drug Administration has granted Breakthrough Therapy Designation ("BTD") for ulixacaltamide for the treatment of patients with essential tremor ("ET"). The BTD enables expedited development and regulatory review for drugs that are intended to treat a serious condition, and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement on a clinically significant endpoint(s) over available therapies. The BTD for ulixacaltamide was based on the positive topline data from the Essential3 program, consisting of two pivotal Phase 3 studies of ulixacaltamide in ET.
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