FDA grants Breakthrough Therapy Designation for relutrigine in SCN2A/SCN8A DEEs

Praxis Precision Medicines, Inc.

FDA granted Breakthrough Therapy Designation for relutrigine in pediatric SCN2A and SCN8A DEEs.
BTD supported by positive data from EMBOLD study cohort 1 and 11-month open-label extension data.
Company initiated EMERALD study evaluating relutrigine across all DEEs.
Company entered quiet period ahead of RADIANT Phase 2 topline results expected by mid-2025.

item 7.01item 8.01

This headline and bullets were generated automatically by deepseek-v4-flash:cloud@v2 from the public filing. Read the source on SEC.gov before relying on any specific claim. Not investment advice. See methodology for how this pipeline works.