Clene(US:CLNN) Globenewswire·2025-12-03 13:00Core Insights - Clene Inc. has completed FDA-recommended biomarker analyses for CNM-Au8 in ALS patients, showing significant reductions in neurofilament light (NfL) and glial fibrillary acidic protein (GFAP), indicating a potential link between biomarker decline and improved survival [1][2][3] Biomarker Analyses - The FDA recommended three specific analyses to strengthen the evidence for CNM-Au8's effect on NfL and its relationship to clinical benefit, including evaluations in the NIH-sponsored Expanded Access Program (NIH-EAP) [3] - Statistically significant reductions in NfL and GFAP were observed in participants treated with CNM-Au8, with improvements strongly associated with longer survival [3][4] - The analyses confirmed the robustness of findings across various pre-specified supportive analyses, with significant effects noted in specific participant subgroups [4][5] Survival Benefit - Updated survival analyses indicate that CNM-Au8 treatment demonstrated a statistically significant survival benefit compared to controls, with a 73% reduction in the risk of death in the full analysis set and a 77% reduction in a risk-balanced population [6][7] - Even among a small cohort of participants who switched from placebo to CNM-Au8, a significant survival benefit was observed, with an average increase of 30.7 days in survival [7] Safety Profile - CNM-Au8 has shown a strong safety profile across over 1,000 patient years of exposure, with no serious adverse events related to the treatment identified [8] Regulatory Pathway - Clene has requested a Type C meeting with the FDA to present the completed analyses and plans to submit a New Drug Application (NDA) under the accelerated approval pathway in early 2026 [11][12]