08:02 AM EDT, 10/16/2025 (MT Newswires) -- Praxis Precision Medicines ( PRAX ) said Thursday that two phase 3 pivotal studies of its investigational drug ulixacaltamide in essential tremor met key primary and secondary endpoints, with the patients showing clinically meaningful improvements in tremor control and daily function.

One study, which enrolled 473 patients, met its primary endpoint of an improvement from baseline in the Modified Activities of Daily Living 11 at week 8, the company said, adding that the study also met all secondary endpoints.

The other study, which enrolled 238 patients, also met its primary endpoint, with patients showing "superior maintenance of effect" during the randomized-withdrawal phase, Praxis said.

The company said ulixacaltamide was generally well tolerated over 12 weeks of treatment, and that there were no deaths and no drug-related serious adverse events during the trials.

Praxis said it has asked the US Food and Drug Administration for a pre-new drug application meeting.

Shares of Praxis Precision Medicines ( PRAX ) were up 108% in recent premarket activity Thursday.