FDA official announcements

Recursion's First-in-Disease Drug REC-994 Meets Safety Endpoint, Efficacy Mixed in Phase 2 Study

Sep 3, 2024, 12:12 PM

Recursion Pharmaceuticals has announced the Phase 2 data for REC-994, its first-in-disease investigational treatment for symptomatic cerebral cavernous malformation (CCM). The AI-derived drug candidate met its primary endpoint of safety and tolerability in the mid-stage study. However, the efficacy results were mixed, with magnetic resonance imaging-based secondary endpoints showing a trend towards reduced lesion volume but not achieving significant efficacy. While the topline results are positive, they may not fully satisfy investors closely monitoring the AI drug developer.