ulixacaltamide is a Praxis Precision Medicines Inc. program in Essential tremor. Its PDUFA date is Jan 29, 2027, the FDA's goal date to complete review of the application. Every date links its source.
Indication under review: Essential tremor. Sponsor: Praxis Precision Medicines Inc. (PRAX). Review status: NDA for essential tremor; Breakthrough Therapy designation December 2025. PDUFA date January 29, 2027; mid-cycle meeting complete with no major safety or efficacy concerns identified to date and no advisory committee planned (Praxis, August 6, 2026). Market-cap tier at the time we tracked it: Mid. We track 1 catalyst event for this program: 1 upcoming and 0 in the record. A PDUFA date is the FDA's target date to complete review of a marketing application; a readout is the sponsor's expected date for clinical trial results. What a PDUFA date is · why we do not compare trial results across drugs.
When is ulixacaltamide's next FDA decision or readout?
ulixacaltamide's PDUFA date is Jan 29, 2027. That is the FDA's goal date to complete review of the application; the agency can act earlier or extend it.
What happened at ulixacaltamide's most recent FDA decision?
No FDA decision for ulixacaltamide is in our archive yet.
What is ulixacaltamide used for?
In our records ulixacaltamide is under review or in development for Essential tremor.
Who makes ulixacaltamide?
Praxis Precision Medicines Inc. (PRAX).
Where does this data come from?
FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.
Facts and dates only; not investment advice. Verify against primary FDA, SEC
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