Upcoming FDA decision · January 29, 2027
Ulixacaltamide (PRAX-944) PDUFA date: FDA decision expected January 29, 2027
105 days to goPraxis Precision Medicines, Inc. (PRAX) →
The FDA is expected to decide on Ulixacaltamide (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 16, 2026. Confirm dates against the company's or the FDA's announcement before acting.
January 29
Target action date
NDA
Stage
Verified
Date confidence
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FDA designations
Questions about this FDA decision
- When is the PDUFA date for Ulixacaltamide (PRAX-944)?
- The FDA's PDUFA target action date for Ulixacaltamide (PRAX-944) is January 29, 2027. The FDA can act before that date, and the review can be extended.
- What is Ulixacaltamide (PRAX-944) being reviewed for?
- The application under FDA review covers Essential tremor.
- Which company is developing Ulixacaltamide (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).