RegulatoryMay 13, 2026, 04:22 PM
Praxis FDA Accepts 2 NDAs; Q1 Net Loss $92.6M; Cash $1.4B
AI Summary
Praxis Precision Medicines announced its first quarter 2026 financial results and provided a corporate update, highlighting significant regulatory and clinical milestones. The FDA accepted New Drug Applications for ulixacaltamide in Essential Tremor and relutrigine in SCN2A and SCN8A DEEs, with PDUFA target action dates in January 2027 and September 2026, respectively. The company also reported positive topline results from the EMBRAVE Part A study for elsunersen, showing a 77% placebo-adjusted seizure reduction. Praxis ended the quarter with $1.4 billion in cash and investments, extending its runway into 2028, despite an increased net loss of $92.6 million.
Key Highlights
- FDA accepted NDA for ulixacaltamide in Essential Tremor with PDUFA target action date of January 29, 2027.
- FDA accepted relutrigine NDA for SCN2A and SCN8A DEEs with priority review and PDUFA target action date of September 27, 2026.
- Elsunersen EMBRAVE Part A study showed 77% placebo-adjusted reduction in monthly seizures for SCN2A-DEE.
- Cash, cash equivalents, and marketable securities totaled $1.4 billion as of March 31, 2026, up from $926.1 million on December 31, 2025.
- Net loss for Q1 2026 was $92.6 million, compared to $69.3 million for Q1 2025.
- Research and development expenses increased to $78.0 million in Q1 2026 from $60.8 million in Q1 2025.
- Topline results from the POWER1 study of vormatrigine in focal onset seizures are expected in Q2 2026.
- Relutrigine EMERALD study recruitment completed, with topline results expected in Q4 2026.
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