FDA accepts Praxis NDA for ulixacaltamide in essential tremor, sets Jan. 29, 2027 action date

The U.S. Food and Drug Administration has accepted for review the New Drug Application for ulixacaltamide HCl for the treatment of essential tremor in adults and assigned a PDUFA target action date of January 29, 2027. No advisory committee meeting is expected. The NDA is supported by positive Essential3 Phase 3 results, and ulixacaltamide was granted Breakthrough Therapy Designation by the FDA in December 2025.

Praxis said two new drug applications were submitted to the FDA, for ulixacaltamide in essential tremor and for relutrigine in SCN2A and SCN8A developmental and epileptic encephalopathies. Pre-launch activities for ulixacaltamide and relutrigine are underway and will accelerate through 2026.

The company said ulixacaltamide was the first investigational therapy to demonstrate positive results in a Phase 3 program in essential tremor. Essential3 results are to be presented as an oral presentation at the American Academy of Neurology Annual Meeting.

As of December 31, 2025, Praxis had $926.1 million in cash, cash equivalents and marketable securities, compared with $469.5 million as of December 31, 2024. The company said its cash, cash equivalents and marketable securities as of December 31, 2025, together with $621.2 million in proceeds from its January 2026 follow-on public offering, are expected to fund operations into 2028.

Research and development expenses were $77.5 million for the fourth quarter of 2025, compared with $56.3 million for the fourth quarter of 2024. Research and development expenses were $267.1 million for the year ended December 31, 2025, compared with $152.4 million for the year ended December 31, 2024. General and administrative expenses were $19.5 million for the fourth quarter of 2025, compared with $15.1 million for the fourth quarter of 2024, while full-year general and administrative expenses were $59.1 million, compared with $56.3 million for 2024.