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

PRAX
  • Praxis completed mid-cycle meetings for ulixacaltamide HCl & relutrigine with the FDA identifying no major safety or efficacy concerns & planning no advisory committee meetings.
  • The PDUFA date for ulixacaltamide HCl is set for January 29, 2027, while the PDUFA date for relutrigine is December 27, 2026.
  • FDA BIMO inspections for ulixacaltamide & relutrigine were completed with no Form FDA 483 observations issued.
  • Commercial infrastructure build-out is accelerating for ulixacaltamide in Essential Tremor & relutrigine in SCN2A & SCN8A developmental epileptic encephalopathies ahead of expected approvals.
  • Praxis received its third Breakthrough Therapy Designation for elsunersen following positive EMBRAVE Part A trial results for seizures in SCN2A DEE.
  • Cash & investments totaled approximately $1.4 billion as of June 30, 2026, maintaining a runway into 2028.
  • Ulixacaltamide is the first investigational therapy in a Phase 3 program for Essential Tremor with a Breakthrough Therapy Designation granted in December 2025.
  • A strategic collaboration was initiated in July 2026 with Remagine Labs to develop a transdermal patch for ulixacaltamide.
  • Relutrigine is the potential first therapy for SCN2A & SCN8A DEEs & will be eligible for a Pediatric Review Voucher if approved.
  • Enrollment in the EMERALD study for relutrigine exceeded targets with ~200 patients, with topline results anticipated in Q4 2026.
  • Vormatrigine did not meet its primary endpoint in the POWER1 study but met the secondary endpoint of ≥50% seizure frequency reduction.
  • Praxis plans to restart the POWER2 study & initiate POWER3 in Q4 2026 based on POWER1 learnings.
  • Elsuenersen holds Breakthrough Therapy, Orphan Drug, Rare Pediatric Disease, & PRIME designations with EMBRAVE3 topline results expected in 2027.
  • Second quarter 2026 research & development expenses were $69.4 million, while general & administrative expenses were $27.5 million.
  • Praxis reported a net loss of $83.7 million for Q2 2026 & had 27.9 million shares outstanding as of June 30, 2026.