Praxis Precision Medicines FDA extends relutrigine review to Dec. 27, 2026

Praxis Precision Medicines said the FDA extended the PDUFA review for relutrigine by three months to December 27, 2026.Key Highlights:Original SEC Filing: Praxis Precision Medicines, Inc. [ PRAX ] - 8-K - Jun. 29, 2026This is an AI-powered summary. It may contain inaccuracies. Consider verifying im…

Praxis Precision Medicines said the FDA extended the PDUFA review for relutrigine by three months to December 27, 2026.

Key Highlights:

FDA set new PDUFA target action date of December 27, 2026, extending review from Sept. 27, 2026 by three months.
Extension follows submission of additional sensitivity analyses, which FDA deemed a "major amendment."
No new clinical studies were requested and FDA cited no safety or manufacturing concerns.
Review remains active; company continues preparations to bring relutrigine to patients with SCN2A and SCN8A DEEs.

Original SEC Filing:

This is an AI-powered summary. It may contain inaccuracies. Consider verifying important information with the source. Please note this summary is solely based on documents filed with the SEC.