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Praxis Precision Medicines Details Launch Readiness for Relutrigine and Ulixacaltamide and Outlines Expanded Pipeline in Preparation to be the Preeminent CNS Biotech at Investor Day

PRAX
  • Praxis Precision Medicines hosted its Investor Day in New York on November 12, 2026, outlining commercial strategies & launch plans for relutrigine & ulixacaltamide.
  • The FDA set PDUFA target action dates of December 27, 2026, for relutrigine in SCN2A & SCN8A developmental epileptic encephalopathies (DEEs).
  • The FDA set a PDUFA target action date of January 29, 2027, for ulixacaltamide in essential tremor (ET).
  • The ulixacaltamide field team of approximately 300 representatives will be fully hired by year-end to cover 19,000 target healthcare professionals.
  • The relutrigine field team is fully hired & has profiled 100% of its top 10 accounts per region & 100% of Tier 1 & Tier 2 target healthcare professionals.
  • Updated long-term efficacy data for ulixacaltamide showed durable & improving activities of daily living responses after approximately 95 weeks of treatment.
  • Updated open-label extension data for relutrigine from the EMBOLD study demonstrated an 86% reduction in seizures from baseline through 18 months.
  • Praxis plans to initiate studies in 2027 to expand ulixacaltamide into Parkinson's disease, Restless Legs Syndrome, & Autism Spectrum Disorder.
  • Two new molecular entities targeting the T-type calcium channel mechanism for movement disorders are expected to enter first-in-human studies in 2027.
  • An iontophoretic transdermal patch for ulixacaltamide developed with Remagine Labs is planned to enter the clinic in 2027.
  • Praxis introduced a pain pipeline featuring PRAX-215, a pan-sodium channel molecule with Phase 1 readouts expected in 2027, & PRAX-110, an isoform-biased molecule expected to enter the clinic in 2028.
  • PRAX-206, a candidate for KCNT1 DEEs, showed strong preclinical data & is planned to enter the clinic in early 2027.
  • The company expanded its Solidus™ antisense oligonucleotide platform to include a portfolio of six preclinical programs in addition to elsunersen, which is in pivotal development.
  • Ulixacaltamide has received Breakthrough Therapy Designation from the FDA, while relutrigine holds Orphan Drug, Rare Pediatric Disease, & Breakthrough Therapy Designations for specific DEE indications.
Company
Praxis Precision Medicines, Inc.
Keywords
Nasdaq:PRAX, Praxis Precision Medicines, Inc.