PRAX narrows net loss 18% to -$83.7M in Q2 as two NDAs advance through FDA review

Filed August 6, 2026 · Period ending June 30, 2026 · Compared to 10-Q Aug 4, 2025 · ~1 min read

Key Changes

• high

  Ulixacaltamide NDA accepted for review with PDUFA date of Jan 29, 2027; mid-cycle review found no major safety or efficacy concerns, no advisory committee planned, and commercial preparations underway for essential tremor treatment.

  MD&A: Ulixacaltamide NDA verify on EDGAR →
• high

  Relutrigine NDA accepted for priority review with PDUFA date extended to Dec 27, 2026; mid-cycle review found no major safety or efficacy concerns and no advisory committee planned for SCN2A/SCN8A DEE treatment.

  MD&A: Relutrigine NDA verify on EDGAR →
• high

  FDA completed comprehensive BIMO inspection covering both NDA applications without issuing Form 483, indicating no significant deficiencies in clinical operations, data integrity, or safety processes.

  MD&A: BIMO Inspection verify on EDGAR →