Praxis Precision Medicines Inc.
Praxis Precision Medicines, Inc. Converts EMBRAVE3 Study Design Following FDA Meeting
Summary
On December 9, 2025, Praxis Precision Medicines, Inc. announced a conversion of the EMBRAVE3 registrational study of elsunersen in early-onset SCN2A developmental and epileptic encephalopathy (DEE) into a single-arm study following a Type C meeting with the FDA. The study will now enroll 30 patients, down from 40, with all patients receiving elsunersen for 24 weeks followed by an open-label extension. Additionally, on December 11, 2025, the Company announced completion of a planned discussion with the FDA leading to the confirmation to file a New Drug Application for relutrigine in SCN2A and SCN8A DEEs in early 2026.
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About Praxis Precision Medicines Inc.
Praxis Precision Medicines Inc. operates within the biopharmaceutical sector, focusing on the development of treatments for central nervous system (CNS) disorders. The company's primary objective is to address unmet medical needs by leveraging their extensive research in genetics, the neurobiology of CNS disorders, and translational science. Praxis Precision Medicines is rapidly carving out a niche in the healthcare field by targeting illnesses such as epilepsy, movement disorders, and psychiatric conditions, which impact millions of individuals globally. Their innovative pipeline includes a variety of therapeutic candidates designed to modulate specific neural pathways that are believed to be core to CNS dysregulation. As an emerging leader in the biopharma industry, Praxis Precision Medicines plays a crucial role in advancing CNS treatment paradigms, working to improve quality of life for patients and expand the possibilities of personalized medicine through cutting-edge science.
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