Praxis Precision Medicines Details Launch Readiness for Relutrigine and Ulixacaltamide and Outlines Expanded Pipeline in Preparation to be the Preeminent CNS Biotech at Investor Day
Globe Newswire•12/11/2026•16:30 ET
0
Key Highlights
- ➤PDUFA dates set for relutrigine December 27, 2026, and ulixacaltamide January 29, 2027
- ➤Relutrigine cut seizures 86% from baseline through 18 months in EMBOLD extension
- ➤Ulixacaltamide showed durable, improving ADL response after approximately 95 weeks
- ➤Praxis plans 2027 ulixacaltamide studies in Parkinson’s, restless legs syndrome, and autism
- ➤PRAX-215 Phase 1 pain study readout expected in 2027; PRAX-110 clinic entry expected 2028
Expert Statements
Marcio Souza, President and Chief Executive Officer of Praxis Precision Medicines
“Praxis is preparing to launch the first therapies designed specifically for SCN2A and SCN8A DEEs and for ET, if approved. Today we showed how our teams are ready to bring both treatments to patients in the coming months. We also provided exciting updates about our portfolio, including expanding ulixacaltamide to new indications, our sodium channel program in pain and additional programs in rare epilepsies. With the launches approaching quickly and the expanded pipeline we introduced today, we are well positioned to become the world’s preeminent CNS company over the next decade”
Detailed launch readiness for relutrigine and ulixacaltamide, with PDUFA target action dates of December 27, 2026 and January 29, 2027
Shared updated long-term efficacy data for both relutrigine and ulixacaltamide
Get started
Create a free account to read the full story.