Praxis Completes FDA Meeting for Tremor Treatment, Reports Positive Results for Epilepsy Drug
By Elias Schisgall
Praxis Precision Medicine said it had completed its pre-new drug application meeting with the Food and Drug Administration for its essential tremor treatment.
The company said Thursday it expects to file the NDA for the treatment, called ulixacaltamide, in early 2026. The application will be the company's first.
Praxis also said it had positive results from its a Phase 2 study evaluating relutrigine for patients suffering from certain forms of developmental and epileptic encephalopathies.
The company said data from the first cohort in the study suggested a well-tolerated safety profile with robust improvement in motor seizures among a heavily pre-treated patient population.
It said the FDA has confirmed a meeting to review the data, adding that the company will determine the timeline for filing an NDA after the meeting.
Praxis will present the results from its relutrigine study at the American Epilepsy Society Annual Meeting on Saturday.
Write to Elias Schisgall at elias.schisgall@wsj.com
(END) Dow Jones Newswires
December 04, 2025 17:28 ET (22:28 GMT)
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