USFDAMay 7, 2026, 08:03 AM
Praxis FDA Accepts 2 NDAs; Elsunersen Shows 77% Seizure Reduction
AI Summary
Praxis Precision Medicines announced FDA acceptance of New Drug Applications for ulixacaltamide in Essential Tremor (PDUFA Jan 29, 2027) and relutrigine in SCN2A/SCN8A DEEs (priority review, PDUFA Sep 27, 2026). The company also reported positive EMBRAVE Part A study results for elsunersen, showing a 77% placebo-adjusted reduction in monthly seizures. Praxis ended Q1 2026 with $1.4 billion in cash, extending its runway into 2028, despite an increased net loss of $92.6 million.
Key Highlights
- FDA accepted NDA for ulixacaltamide in Essential Tremor; PDUFA target date Jan 29, 2027.
- FDA accepted NDA for relutrigine in SCN2A/SCN8A DEEs with priority review; PDUFA target date Sep 27, 2026.
- Elsunersen EMBRAVE Part A study showed 77% placebo-adjusted reduction in monthly seizures.
- Cash and investments totaled $1.4 billion as of March 31, 2026, extending runway into 2028.
- Net loss for Q1 2026 was $92.6 million, compared to $69.3 million in Q1 2025.
- Research and development expenses increased by $17.2 million to $78.0 million in Q1 2026.
- Topline results for vormatrigine POWER1 study in focal onset seizures expected in Q2 2026.
- Topline results for relutrigine EMERALD study in broad DEEs expected in Q4 2026.