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Praxis Precision Medicines Provides Corporate Update and Reports Fourth Quarter and Full-Year 2025 Financial Results

PRAX
  • Praxis Precision Medicines submitted two new drug applications (NDAs) to the FDA: ulixacaltamide for essential tremor (ET) and relutrigine for SCN2A and SCN8A developmental epileptic encephalopathies (DEEs).
  • Pre-launch activities for ulixacaltamide and relutrigine are underway and will accelerate through 2026.
  • Essential3 study results for ulixacaltamide will be presented as an oral presentation at the American Academy of Neurology Annual Meeting in April 2026.
  • Cash, cash equivalents, and marketable securities totaled $926 million as of December 31, 2025, with an additional $621 million in net proceeds from a January 2026 public offering expected to fund operations into 2028.
  • Vormatrigine and elsunersen programs are on track for topline results in the first half of 2026, supporting potential additional NDA submissions in the next two years.
  • CEO Marcio Souza stated the four late-stage assets have a combined revenue potential exceeding $20 billion.
  • Ulixacaltamide is the first investigational therapy to show positive Phase 3 results in ET, holding Breakthrough Therapy Designation, with commercial scaling, inventory building, and a disease awareness campaign planned for 2026.
  • Relutrigine holds Breakthrough Therapy Designation and Orphan Drug Designation for SCN2A and SCN8A DEEs, with the EMERALD study expected to fully enroll in the second half of 2026.
  • Vormatrigine Phase 3 POWER1 study exceeded enrollment targets with topline results expected in Q2 2026, while POWER2 enrollment continues with completion expected in late 2026.
  • The EMBRAVE Phase 1/2 study for elsunersen is on track for topline results in the first half of 2026, with a registrational EMBRAVE3 design updated to remove the sham control arm.
  • Praxis appointed Jeffrey B. Kindler and Stuart Arbuckle to its Board, promoted Megan Sniecinski to Chief Operating Officer, Steven Petrou to President of Research & Development, and Orrin Devinsky to Head of Clinical Strategy.
  • Research and development expenses were $77.5 million for Q4 2025 and $267.1 million for the full year 2025, while general and administrative expenses were $19.5 million for Q4 2025 and $59.1 million for the full year 2025.
  • The company reported a net loss of $88.9 million for Q4 2025 and $303.3 million for the full year 2025, with 25.2 million shares of common stock outstanding as of December 31, 2025.
  • A conference call to discuss Q4 and full-year 2025 financial results is scheduled for February 19, 2026, at 8:00 am ET.