Vormatrigine

Search documents
Praxis(PRAX) - 2025 Q2 - Earnings Call Presentation
2025-08-04 12:30
Vormatrigine Efficacy and Development - RADIANT study showed a 56.3% overall median seizure reduction with vormatrigine[21] - A significant proportion of patients achieved ≥50% seizure reduction, independent of baseline seizure burden[26] - Vormatrigine is being developed as a potential stand-alone agent, with POWER3 study expected to initiate in 1H 2026[40, 42] - POWER2 study is staged to initiate this quarter and complete enrollment in 2H 2026, with a sample size of approximately 400 patients[37] Safety and Tolerability - In the RADIANT study, 59% of patients experienced ≥1 treatment-emergent adverse event (TEAE) with vormatrigine 30 mg[33] - 4.9% of patients experienced severe adverse events (AEs) and serious AEs (SAEs) with vormatrigine 30 mg[33] - 1.6% of patients experienced a related SAE with vormatrigine 30 mg[33] Pipeline and Catalysts - The company has assets in late stage development, with clinical readouts expected in the next 4 quarters[7] - Topline results for the RADIANT Phase 2 study are expected by mid-2025[8] - Finalization of the POWER1 Phase 2/3 study is expected in Q4 2025[8] - Candidate declaration for PRAX-100 (SCN2A LoF) is expected by mid-2025, and for PRAX-080 (PCDH19) and PRAX-090 (SYNGAP1) by year-end 2025[8] Financial Position - The company has a cash runway into 2028[7]