Business
Praxis Precision Medicines Enters Its Next Chapter Following a Pivotal Year of Progress
Two NDA submissions expected by mid-February 2026 for ulixacaltamide in essential tremor and relutrigine in SCN2A/8A-DEEs, both with Breakthrough Therapy
About this update from Praxis Precision Medicines, Inc.
[{"type":"text","content":"Two NDA submissions expected by mid-February 2026 for ulixacaltamide in essential tremor and relutrigine in SCN2A/8A-DEEs, both with Breakthrough Therapy Designation from the FDA Multiple registrational readouts expected across vormatrigine, relutrigine and elsunersen in 2026 Strong balance sheet, with $1.5 billion in pro forma cash and investments Combined peak revenue estimates for the four late-stage assets expected to exceed $20 billion BOSTON, Jan. 12, 2026 (GLOBE NEWSWIRE) -- Praxis Precision Medicines, Inc. (NASDAQ: PRAX), a fully integrated, leading central nervous system (CNS) precision neuroscience biopharmaceutical company, today announced its business outlook and priorities for 2026. “2025 was a year of exceptional execution for Praxis, positioning the company for multiple product launches and our transformation into a commercial-stage organization. Both ulixacaltamide and relutrigine delivered compelling late-stage results and earned Breakthrough Therapy Designation, marking the first therapies specifically designed for essential tremor and SCN2A/8A-DEEs, respectively. As we enter 2026, our focus broadens from clinical execution to commercial readiness, with a clear priority on bringing these transformative therapies to patients as efficiently as possible,” said Marcio Souza, president and chief executive officer.Highlights of Key Clinical and Regulatory Milestones in 2025 The year 2025 was marked by exemplary performance, transformational portfolio progress and the creation of significant long-term value for both patients and shareholders. Throughout 2025, Praxis initiated four registration-enabling studies across the epilepsy portfolio, including POWER1 and POWER2 with vormatrigine for the treatment of focal onset seizures (FOS), the EMERALD study with relutrigine in broad developmental and epileptic encephalopathies (DEEs) and the EMBRAVE3 study with elsunersen in early-seizure-onset SCN2A DEEs.In July 2025, FDA granted Breakthrough Therapy Designation to relutrigine for the treatment of SCN2A and SCN8A DEEs.In August 2025, Praxis reported meaningful seizure reduction and seizure control in patients with FOS in the RADIANT study of vormatrigine.In October 2025, ulixacaltamide delivered positive results in both pivotal studies in the Essential3 program, representing the first successful Phase 3 program for a pharm...