By Colin Kellaher
Shares of Praxis Precision Medicines rose sharply on Monday after the clinical-stage biopharmaceutical company won a key U.S. Food and Drug Administration designation for its drug candidate for essential tremor.
Praxis on Monday said the FDA granted breakthrough-therapy designation to ulixacaltamide for people with the nervous-system condition that causes rhythmic shaking that they can't control.
Analysts at Truist, who have a buy rating and $500 price target on Praxis shares, said the designation is incrementally positive and derisking for the Boston company's essential-tremor program.
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.
Praxis said it is on track for filing for FDA approval of ulixacaltamide in early 2026.
Praxis shares were recently changing hands at $300.74, up nearly 13%.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
December 29, 2025 10:42 ET (15:42 GMT)
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