Essential tremor
PRAXPraxis Precision MedicinesCatalyst overview
Research summary
This catalyst tracks a PDUFA approval decision for Ulixacaltamide (PRAX-944) (T-type calcium channel blocker) in Essential tremor. The expected timing is based on the latest available company guidance and may change.
Essential1 & Essential3 trials: 8/9/23- Initiated trial. 2/28/25- IDMC recommended study to be stopped for futility. 5/2/25- Decided to continue study. 10/16/25- Topline results reported. 12/4/25– Completed pre-NDA meeting. NDA filing early 2026. 12/29/25:- FDA granted BTD in ET; NDA filing still expected in Early 2026. 01/12/26:- NDA submission now expected by mid-February 2026. Commercial build-out and pre-launch activities accelerating. 02/19/26:- NDA for essential tremor submitted. ESSENTIAL3 results to be presented orally at AAN April 19–22, 2026; launch preparations accelerating. 04/13/26:- Expanded Essential3 analyses presented at AAN 2026, including plenary April 21, 2026. 04/14/26:- FDA accepted ET NDA; PDUFA January 29, 2027. No AdCom expected. 05/07/26:- PDUFA Jan 29, 2027 reaffirmed. Launch preparations accelerating, including ESSENTIAL to me campaign; Essential3 plenary recognized by AAN. 08/06/26:- Mid-cycle meeting completed; no AdCom planned. PDUFA remains Jan 29, 2027.
Verification
Confirm timing and program details against the company announcement or filing.