Praxis gains FDA alignment for ulixacaltamide NDA; relutrigine & vormatrigine trials positive

Praxis Precision Medicines, Inc.

Ulixacaltamide pre-NDA meeting with FDA completed; NDA submission expected early 2026.
Relutrigine EMBOLD study stopped early for efficacy; 53% placebo-adjusted seizure reduction (p<0.0002) over 16 weeks.
Relutrigine: 66% increase in motor seizure-free days (p=0.034); no drug-related serious adverse events.
Vormatrigine RADIANT FOS cohort (n=62): 54% median seizure reduction at 8 weeks; 11% seizure-free for entire 8-week period.
Vormatrigine POWER1 pivotal study fully enrolled; POWER2 on track for H2 2026; POWER3 monotherapy starts H1 2026.

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