Praxis ulixacaltamide Essential3 Phase 3 meets primary endpoint: 4.3 pt mADL11 improvement vs placebo (p<0.0001)

Praxis Precision Medicines, Inc.

Study 1: 4.3 pt mean improvement in mADL11 at Week 8 vs 1.7 pt placebo (p<0.0001); all key secondary endpoints significant.
Study 2 randomized withdrawal: 55% maintained response on ulixacaltamide vs 33% placebo (p=0.037, OR=2.7).
Common TEAEs included constipation, dizziness, euphoric mood, brain fog; no deaths or drug-related serious AEs.
Pre-NDA meeting submitted to FDA; NDA submission planned by early 2026.
Discontinuation rates due to TEAEs: 27% ulixacaltamide vs 1.7% placebo in Study 1.

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