Praxis Precision: FDA accepts NDA for ulixacaltamide in essential tremor; PDUFA Jan 29, 2027

Praxis Precision Medicines, Inc.

FDA accepted NDA for ulixacaltamide HCl to treat essential tremor in adults; PDUFA target action date January 29, 2027.
No advisory committee meeting will be held for the ulixacaltamide NDA review.
The NDA seeks approval for a novel small-molecule therapy for a common movement disorder.

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