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PRAX — Praxis Precision Medicines News Story

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Praxis rises as FDA sets review date for drug to treat essential tremor

** Shares of biotech firm Praxis Precision Medicines PRAX.O rise 7% to $335 premarket

** Co says the FDA accepted its application for ulixacaltamide to treat essential tremor, a common nerve condition that causes involuntary shaking, mainly in the hands

** Adds the FDA set a target decision date of January 29, 2027, and does not plan to hold an advisory panel meeting

** Says application backed by two late-stage studies showing the drug met its main goal and was generally well tolerated, with no serious safety issues

** Adds ulixacaltamide received FDA Breakthrough Therapy designation in December 2025, which could speed up the review process

** Praxis says it is preparing for a commercial launch of the drug, pending approval

** As of last close, stock up ~8% YTD

 (Reporting by Sahil Pandey in Bengaluru)

 ((Sahil.Pandey@thomsonreuters.com))

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