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Praxis Precision Medicines Provides Corporate Update and Reports Third Quarter 2026 Financial Results

  • FDA reviews for relutrigine (PDUFA date December 27, 2026) & ulixacaltamide HCl (PDUFA date January 29, 2027) are ongoing.
  • Topline results from the EMERALD study of relutrigine in broad developmental & epileptic encephalopathies are expected in Q4 2026.
  • Cash & investments of approximately $1.3 billion as of September 30, 2026, maintain a runway into 2028.
  • Praxis hosted an investor fireside chat at the Guggenheim Biotech Summit on November 9, 2026, & will host an in-person & virtual Investor Day on November 12, 2026.
  • Ulixacaltamide is the first investigational therapy to show positive Phase 3 results in essential tremor & holds Breakthrough Therapy Designation.
  • Commercial launch preparations for ulixacaltamide continue with the sales force hiring expected to be completed in Q4 2026.
  • Relutrigine is under review for SCN2A & SCN8A developmental & epileptic encephalopathies & is eligible for a Pediatric Review Voucher if approved.
  • The relutrigine commercial team is fully hired & preparations for a potential launch are well advanced.
  • Vormatrigine's POWER2 study has restarted incorporating learnings from POWER1, with POWER3 monotherapy study initiation expected in 2027.
  • Elsunersen enrollment in the EMBRAVE3 registrational trial is progressing strongly with topline results anticipated in 2027.
  • Cash, cash equivalents, & marketable securities increased to $1.3 billion from $926.1 million in Q4 2025 due to a follow-on public offering & interest income.
  • R&D expenses for Q3 2026 were $64.2 million, down from $65.8 million in Q3 2025, while G&A expenses rose to $42.7 million from $12.6 million.
  • Praxis incurred a net loss of $94.2 million for Q3 2026, compared to $73.9 million in Q3 2025.
  • As of September 30, 2026, Praxis had 27.9 million shares of common stock outstanding.