Clene receives constructive FDA feedback on NfL biomarker analysis plan; ALS NDA on track for Q4 2025

Clene Inc.

FDA provided supportive feedback on Clene's statistical analysis plan for neurofilament light (NfL) biomarker analysis from NIH-sponsored Expanded Access Program.
NfL analyses to be conducted early Q4 2025; may support accelerated approval NDA submission for CNM-Au8 in ALS.
Two additional FDA meetings scheduled in Q3 2025: ALS survival data Type C and End-of-Phase 2 MS program Type B.
NDA submission under accelerated approval pathway remains on track for potential submission in Q4 2025.
EAP supports nearly 200 ALS patients treated with compassionate use CNM-Au8; comparator group uses matched controls.

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