Clene to submit FDA briefing book for CNM-Au8 accelerated approval in ALS by July 13

Clene Inc.

Briefing book submission due July 13, 2024, for Type C interaction with FDA in Q3 2024.
New post-hoc analyses include NfL biomarker reduction, survival data, and mechanism-of-action evidence.
Data designed to address prior FDA comments from December 2023 meeting on accelerated approval path.
Clene plans to disclose topline FDA feedback after the Type C interaction concludes.

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