Praxis Precision Medicines Inc. (NASDAQ: PRAX) announced that the U.S. Food and Drug Administration has accepted its New Drug Application for ulixacaltamide HCl to treat essential tremor in adults.

The FDA set a target action date of January 29, 2027, under the Prescription Drug User Fee Act and does not plan to hold an advisory committee meeting for the application.

"Today's announcement brings us one step closer to delivering something patients living with essential tremor have been waiting for, a therapy developed specifically for their condition," said Marcio Souza, president and chief executive officer.

The application is supported by results from the Essential3 Phase 3 program, which included two pivotal studies in adults with essential tremor. The company reported that ulixacaltamide was generally well tolerated with a safety profile consistent with previous trials and no drug-related serious adverse events.

Ulixacaltamide received Breakthrough Therapy Designation from the FDA in December 2025. The drug is designed as a selective small molecule inhibitor of T-type calcium channels intended to block abnormal neuronal burst firing in brain circuits associated with tremor activity.

Praxis describes itself as a central nervous system precision neuroscience biopharmaceutical company that develops therapies for neurological disorders. The company has established a portfolio including multiple programs across movement disorders and epilepsy, with four late-stage product candidates.