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Praxis Precision Medicines Provides Corporate Update and Reports Third Quarter 2025 Financial Results

PRAX
  • Praxis Precision Medicines announced positive results from two pivotal Phase 3 Essential3 studies of ulixacaltamide HCl in essential tremor (ET), marking the first successful Phase 3 program for an ET drug.
  • Ulixacaltamide demonstrated significant improvements in mADL11 scores of 4.3 points at Week 8 (p<0.0001) with effects sustained through Week 12 across both studies.
  • A pre-NDA meeting with the FDA is scheduled for Q4 2025 to discuss the first NDA submission for ulixacaltamide.
  • Praxis plans to accelerate relutrigine development in SCN2A & SCN8A DEE patients following an FDA Type B meeting that aligned on using the EMBOLD study's interim analysis for a potential early 2026 NDA submission.
  • Recruitment for the POWER1 study of vormatrigine in focal onset seizures is complete, with topline results expected in the first half of 2026.
  • The POWER2 study for vormatrigine has started, with enrollment expected to conclude in the second half of 2026.
  • Praxis reported pro forma cash & investments of approximately $956 million, including proceeds from an October 2025 public offering, funding operations into 2028.
  • Research & development expenses for Q3 2025 were $65.8 million, up from $41.9 million in Q3 2024, driven by increased activity in the Cerebrum™ platform.
  • The company reported a net loss of $73.9 million for the three months ended September 30, 2025, compared to $51.9 million in the prior year period.
  • Collaboration revenue was $0 in Q3 2025, down from $0.3 million in Q3 2024, due to the expiration of the UCB option & license agreement.
  • Cash, cash equivalents, & marketable securities stood at $389.2 million as of September 30, 2025, prior to the October 2025 offering which generated $567.0 million in net proceeds.
  • The elsunersen program for SCN2A GoF-DEE remains on track for EMBRAVE Part A topline results in H1 2026, with EMBRAVE3 recruitment ongoing.
  • Praxis aims to nominate development candidates for PRAX-080, PRAX-090, & PRAX-100 in the first half of 2026.