Praxis Gets FDA Breakthrough Designation for Essential Tremor Drug
By Colin Kellaher
Praxis Precision Medicines has won Food and Drug Administration breakthrough-therapy designation for its ulixacaltamide drug candidate for the treatment of patients with essential tremor.
Praxis on Monday said it expects to file early next year for FDA approval of ulixacaltamide in essential tremor, a nervous-system condition that causes rhythmic shaking that patients can't control.
The FDA's breakthrough-therapy designation aims to expedite the development and review of a drug for serious conditions when preliminary clinical evidence shows the drug might offer substantial improvement over available therapies.
Boston clinical-stage biopharmaceutical company Praxis in October reported that a pair of Phase 3 studies of ulixacaltamide had met their primary endpoints, showing statistically significant and clinically meaningful improvement in a measure of essential self-care tasks and a superior maintenance of effect for patients on ulixacaltamide versus placebo during a randomized withdrawal phase.
Praxis shares, which closed Friday at $268.95, were recently up nearly 11% to $297.83 in light premarket trading.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
December 29, 2025 08:36 ET (13:36 GMT)
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