Praxis secures two FDA PDUFA dates: relutrigine Sept 2026, ulixacaltamide Jan 2027

Filed May 7, 2026 · Period ending May 7, 2026 · ~1 min read

Key Changes

• high

  FDA accepted relutrigine NDA with priority review for SCN2A/8A epilepsy, setting PDUFA date of Sept 27, 2026; would be first approved therapy for these conditions and eligible for Pediatric Review Voucher.

  Item 7.01 — Regulation FD Disclosure verify on EDGAR →
• high

  FDA accepted ulixacaltamide NDA for Essential Tremor with PDUFA date of Jan 29, 2027; first investigational therapy to show positive Phase 3 results in ET, a condition affecting ~7M U.S. patients with no ET-specific FDA-approved treatments.

  Item 7.01 — Regulation FD Disclosure verify on EDGAR →
• high

  Elsunersen achieved 77% placebo-adjusted seizure reduction (p=0.015) in EMBRAVE Part A trial; 71% of patients had >50% seizure reduction, 57% achieved seizure freedom periods, and 100% showed developmental improvements vs. none on placebo.

  Exhibit 99.1 verify on EDGAR →