Clene reports CNM-Au8 biomarker data supporting potential accelerated approval; FDA meeting in Q1 2026

Clene Inc.

FDA granted in-person Type C meeting in Q1 2026 to discuss CNM-Au8 regulatory path for ALS.
New analyses across ALS cohorts show ~10% NfL reduction associated with 8-13% lower mortality risk.
In HEALEY trial, IGFBP7 responders to CNM-Au8 30mg had 78% mortality risk reduction (HR 0.22, p=0.01).
CNM-Au8 consistently reduced NfL: HEALEY Week 24 GMR 0.905 (p=0.04) and NIH EAP Week 36 AUC diff -0.090 (p=0.037).
Genetic variant linked to lower IGFBP7 expression correlates with ALS reversals, supporting CNM-Au8 mechanism.

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