Praxis Precision's tremor-drug trial succeeds where others have failed. The stock is skyrocketing.
By James Rogers
Shares of Praxis Precision Medicines hit their highest intraday level since March 2022
Biopharmaceutical company Praxis Precision Medicines says that Phase 3 trials of its ulixacaltamide drug have generated positive top-line results.
Shares of biopharmaceutical company Praxis Precision Medicines Inc. soared Thursday, boosted by the successful trial of a new drug to treat movement disorders.
The drug, ulixacaltamide, targets essential tremor, a difficult-to-treat nervous-system condition that causes rhythmic shaking and can affect any part of the body, but typically affects hands.
On Thursday, Praxis Precision (PRAX) said that two Phase 3 trials of ulixacaltamide have generated positive top-line results, adding to the company's status as a front-runner in movement-disorder drug development.
Oppenheimer analyst Jay Olson recently described Praxis Precision as a leader and "uniquely positioned" in the movement-disorder drug space after the failure of Phase 2 trials from Jazz Pharmaceuticals PLC (JAZZ) and Sage Therapeutics Inc. last year.
Ulixacaltamide could also provide an alternative to propranolol, a beta blocker used to treat a number of conditions, including essential tremor, which received its first FDA approval in 1967. In a note released earlier this month, Olson said that Praxis Precision could tap into an patient population of around 2 million people who are "currently seeking alternative therapy" to propranolol.
Investors welcomed the results of the drug trial, sending Praxis Precision Medicine's stock skyrocketing 184% on Thursday, its largest daily percentage increase on record, according to Dow Jones Market Data, based on available data back to Oct. 16, 2020. Praxis Precision shares traded as high as $205.89, hitting their highest intraday level since March 9, 2022, when they hit $207.97. Shares closed Thursday at $162.71.
Some 473 patients were enrolled in the first of the Phase 3 studies and received either ulixacaltamide or a placebo for 12 weeks. Patients treated with ulixacaltamide showed a mean improvement in their ability to perform daily activities at week eight of the study, according to Praxis Precision.
The second Phase 3 study involved 238 patients, who received ulixacaltamide for eight weeks. Patients showed superior maintenance of effect while on ulixacaltamide versus a placebo during a randomized withdrawal phase, Praxis Precision said.
The company has submitted a pre-new-drug-application (pre-NDA) meeting request with the U.S. Food and Drug Administration. "We look forward to hearing back from the agent to move this program forward," said Praxis Precision Chief Executive Marcio Souza during a conference call to discuss the trial results Thursday, according to a FactSet transcript.
-James Rogers
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10-16-25 1649ET
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