Overview
- Praxis reported that both Essential3 Phase 3 studies met their primary endpoints, with Study 1 showing a 4.3‑point mean improvement on the mADL11 scale at Week 8 (p<0.0001).
- In the randomized‑withdrawal Study 2, 55% of patients on ulixacaltamide maintained response versus 33% on placebo (p=0.0369), supporting durability of effect.
- The company said the drug was generally well tolerated over 12 weeks, citing common adverse events such as dizziness, brain fog, constipation, headache, tingling and insomnia, with no deaths or drug‑related serious adverse events reported.
- Praxis has requested a pre‑NDA meeting with the FDA and is targeting an NDA submission in early 2026, with plans to share fuller data at upcoming medical conferences and in publications.
- Shares surged following the announcement, and TD Cowen raised its price target to $251 while other firms also boosted estimates, reflecting expectations for a sizable market opportunity.