Praxis Receives FDA Approval for Two NDAs, Plans U.S. Launches in Eight Months
"This quarter marks yet another inflection point for Praxis, with FDA acceptance of NDAs for both ulixacaltamide and relutrigine, positioning us for two U.S. launches within the next eight months as we accelerate our commercial roadmap to ensure readiness and market access upon approval. Our clinical pipeline continues to deliver, with EMBRAVE Part A data showing a 77% placebo-adjusted reduction in monthly seizures and disease-modifying improvements for elsunersen in early-onset SCN2A-DEE. Looking ahead, we expect topline results from the POWER1 study of vormatrigine in focal epilepsy this quarter, followed by the EMERALD readout in broad DEEs in the fourth quarter. Importantly, we remain well-capitalized to execute on this catalyst-rich period and deliver these therapies to patients," said Marcio Souza, president and chief executive officer.
