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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 (DEEs) are expected in Q4 2026.
  • Cash & investments totaled approximately $1.3 billion as of September 30, 2026, funding operations into 2028.
  • Praxis hosted a fireside chat at the Guggenheim Biotech Summit on November 9, 2026, & will host an Investor Day on November 12, 2026.
  • Ulixacaltamide for Essential Tremor received Breakthrough Therapy Designation in December 2025 & the NDA is under FDA review.
  • Commercial launch preparations for ulixacaltamide include a completed leadership team & field sales force hiring expected in Q4 2026.
  • Praxis initiated a strategic collaboration with Remagine Labs in July 2026 to develop a transdermal patch for ulixacaltamide.
  • Relutrigine for SCN2A & SCN8A DEEs holds Breakthrough Therapy & Orphan Drug Designations & preparations for commercial launch are advanced.
  • Vormatrigine's POWER2 study restarted following design updates, with POWER3 monotherapy study initiation expected in 2027.
  • Enrollment for the EMBRAVE3 trial of Elsunersen for SCN2A DEE continues, with topline results anticipated in 2027.
  • Research & development expenses were $64.2 million for Q3 2026, down from $65.8 million in the prior year period.
  • General & administrative expenses rose to $42.7 million in Q3 2026 from $12.6 million in the prior year period.
  • Praxis reported a net loss of $94.2 million for Q3 2026, compared to $73.9 million in the same period last year.
  • Shares of common stock outstanding totaled 27.9 million as of September 30, 2026.
Company
Praxis Precision Medicines, Inc.
Keywords
Nasdaq:PRAX, Praxis Precision Medicines, Inc.