FDA provides roadmap for accelerated approval of Clene's CNM-Au8 in ALS via additional NfL biomarker data

Clene Inc.

FDA recommends leveraging additional NfL data from three Expanded Access Protocols and HEALEY trial to support accelerated approval; follow-up meeting early 2025.
Additional NfL biomarker analyses planned to complete Q2 2025; NDA submission targeted mid-2025.
Confirmatory Phase 3 RESTORE-ALS trial to start enrollment before NDA submission, evaluating survival benefit.
Key survival data from November meeting: 78% risk reduction in time to death at Month 12 (HR=0.224, p=0.042).
Over 700 patient-years of CNM-Au8 use with no significant safety concerns; no SAEs related to treatment.

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