PRAX
Ulixacaltamide
FDA PDUFA Target Action Date · Praxis Precision Medicines, Inc.
Friday, January 29, 2027
131 days away
Note: NDA accepted (May 7, 2026); Standard review.
Drug Information
- Drug Name
- Ulixacaltamide (CT.gov)
- Application Type
- NDA
- FDA Designations
- Breakthrough Therapy
- Indication
- Essential tremor
Filing Details
- Company
- Praxis Precision Medicines, Inc.
- Stock Ticker
- PRAX
- SEC CIK
- 0001689548
- Source
- SEC 8-K →
What is a PDUFA Date?
A PDUFA (Prescription Drug User Fee Act) date is the FDA's target deadline to complete review of a drug application. The FDA aims to make an approval decision by this date.
- Standard Review: 10 months from filing acceptance
- Priority Review: 6 months from filing acceptance
- Possible Outcomes: Approval, Complete Response Letter (CRL), or extension
Track All FDA Decisions
View all upcoming PDUFA dates and AdCom meetings on our FDA Calendar.
View FDA Calendar →Data sourced from SEC EDGAR filings. Last updated: 2026-06-29. Report an issue