Shots:
- The US FDA has granted BTD to ulixacaltamide for the treatment of patients with essential tremor (ET)
- Designation was based on the topline data from the Essential3 program, consisting of Study 1 & 2, where in Study 1, ulixacaltamide improved mADL11 (1EP) by 4.3 points at Wk. 8, while Study 2 showed superior maintenance of effect vs PBO
- Additionally, in Dec 2025, Praxis completed a pre-NDA meeting with the FDA, aligned on NDA content, & plans to submit the ulixacaltamide NDA in early 2026
Ref: Praxis | Image: Praxis | Press Release
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