PRAX-944 PDUFA date: FDA decision expected January 29, 2027
The FDA is expected to decide on PRAX-944 from Praxis Precision Medicines, Inc. in Essential tremor by the PDUFA target action date of January 29, 2027. For essential tremor. NDA; mid-cycle review completed, no advisory committee planned. 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 31, 2026. How we check dates. Confirm dates against the company's or the FDA's announcement before acting.
Get an email when this FDA date moves or the decision lands
Track Praxis Precision Medicines, Inc. (PRAX) and we email you when an FDA date moves, 7 days and 1 day before the decision when the exact day is known, and when it is announced. Free account, no card.
Questions about this FDA decision
- When is the PDUFA date for PRAX-944?
- The FDA's PDUFA target action date for PRAX-944 is January 29, 2027. The FDA can act before that date, and the review can be extended.
- What is PRAX-944 being reviewed for?
- The application under FDA review covers Essential tremor.
- Which company is developing PRAX-944?
- 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).