Clene Announces Statistically Significant ALS Biomarker Results Supporting Accelerated Approval for CNM-Au8

Clene Inc.

FDA-recommended analyses show statistically significant reductions in NfL (p=0.0373) and GFAP (p<0.05) in ALS patients treated with CNM-Au8.
CNM-Au8 treatment associated with 73-77% reduction in risk of death at 1 year in HEALEY ALS Platform Trial open-label extension (p=0.0144).
Company requested Type C meeting with FDA in Q1 2026 for planned NDA submission under accelerated approval pathway.
Placebo participants who switched to CNM-Au8 showed NfL decline or stabilization, consistent with active arm trajectory.
Over 1,000 patient years of exposure data show no drug-related serious adverse events.

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