Clene submits CNM-Au8 data to FDA: 57% survival benefit, 28% NfL reduction in ALS responders

Clene Inc.

CNM-Au8 NfL Responders (nearly half of treated) showed 28% mean NfL reduction vs. increase in non-responders (p<0.00001).
CNM-Au8 30mg in HEALEY trial: 57% decreased mortality risk vs. PRO-ACT controls (HR 0.431, p=0.0002).
CNM-Au8 30mg in RESCUE-ALS: 70% decreased mortality risk vs. PRO-ACT (HR 0.311, p=0.0035).
NfL Responders showed significantly less ALSFRS-R decline at Weeks 64-100 (p<0.01 vs non-responders).
FDA Type C interaction expected Q3 2024 to discuss accelerated approval pathway based on these results.

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