PRAX PDUFA date: FDA decision expected January 31, 2027

The FDA is expected to decide on this application from Praxis Precision Medicines, Inc. by the PDUFA target action date of January 31, 2027. Praxis has a PDUFA decision expected in early 2027 for ulixacaltamide, with elsunersen having received Breakthrough Therapy Designation status. The analyst rates the company a 'Strong Buy' ahead of these regulatory catalysts.

A PDUFA date is the FDA's target deadline to complete its review of a drug application — approval, a complete response letter (CRL), or an extension are all possible. What is a PDUFA date? This page is research information, not financial advice.