FDA hits Praxis with 3-month delay for epilepsy drug verdict
The FDA has pushed back its PDUFA decision date for Praxis Precision Medicines' epilepsy drug relutrigine by approximately three months, according to analyst commentary.
Praxis Precision Medicines
Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into precision therapies for central nervous system (CNS) disorders, with a focus on epilepsy and broader neuroscience.
Company Info
Sector:Small Molecule Pharma
Headquarters:Boston, Massachusetts, United States
Founded:2020
Website:praxismedicines.com/
Upcoming Milestones & Key Dates
2026-09-29
PDUFA
Relutrigine PDUFA (FDA)
2026-Q4
Regulatory
PRAX-080 IND submission
Clinical Development Pipeline
Relutrigine (PRAX-222)
Target: Nav1.1 modulatorPRAX-080
Target: Sodium channel modulatorPRAX-090
Target: T-type calcium channelRecent News
Leadership Team
Marcio Souza
President and Chief Executive Officer (since April 2020)
Dr. Orrin Devinsky
Head of Clinical Strategy
Dr. Megan Petrou
Head of Research & Development