PRAX-562 PDUFA date: FDA decision expected December 27, 2026
The FDA is expected to decide on PRAX-562 from Praxis Precision Medicines, Inc. in SCN2A and SCN8A developmental and epileptic encephalopathies by the PDUFA target action date of December 27, 2026. For SCN2A and SCN8A developmental and epileptic encephalopathies. NDA; review extended after a major amendment, mid-cycle review completed. Verified against the company announcement on 2026-10-16.
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.
Source: sec.gov · Data checked October 16, 2026. Confirm dates against the company's or the FDA's announcement before acting.
Questions about this FDA decision
- When is the PDUFA date for PRAX-562?
- The FDA's PDUFA target action date for PRAX-562 is December 27, 2026. The FDA can act before that date, and the review can be extended.
- What is PRAX-562 being reviewed for?
- The application under FDA review covers SCN2A and SCN8A developmental and epileptic encephalopathies.
- Which company is developing PRAX-562?
- Praxis Precision Medicines, Inc. (PRAX).
- What can happen on a PDUFA date?
- The FDA approves the application, issues a complete response letter (CRL) listing what must be fixed before approval, or extends the review (typically by three months after a major amendment).