NasdaqGS:PRAXBiotechs
Praxis Precision Medicines (PRAX) Is Up 8.1% After FDA Accepts Ulixacaltamide NDA for Essential Tremor
Praxis Precision Medicines recently reported that the FDA accepted its New Drug Application for ulixacaltamide HCl to treat adult essential tremor, supported by statistically and clinically significant Phase 3 Essential3 data and prior Breakthrough Therapy Designation.
This regulatory milestone, with a PDUFA action date set for January 29, 2027 and no planned advisory committee, could reshape expectations for Praxis’s central nervous system portfolio alongside its epilepsy programs.
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