Praxis Precision Medicines Inc. (NASDAQ:PRAX) shares are up on Tuesday as the company announced FDA acceptance of its New Drug Application (NDA) for ulixacaltamide HCl, a treatment for essential tremor.

Praxis Precision Medicines is a fully integrated central nervous system (CNS) precision neuroscience biopharmaceutical company, focused on genetic epilepsies.

Essential tremor is a common, often inherited, neurological disorder causing involuntary, rhythmic shaking, typically in the hands, head, or voice during movement.

The FDA has set a target action date of January 29, 2027, for ulixacaltamide, which has received Breakthrough Therapy Designation.

This announcement is seen as a significant step toward delivering a much-needed therapy for patients suffering from essential tremor.

Phase 3 Data Supports FDA Filing

The NDA is supported by positive results from the Essential3 Phase 3 program, which comprised two simultaneously enrolled pivotal studies in adults with essential tremor.

Study 1 showed a statistically significant and clinically meaningful 4.3-point mean improvement in the mADL11 score at Week 8.

In ...