Clene Reports Statistically Significant ALS Biomarker Results for CNM-Au8 Supporting Accelerated FDA Approval Pathway

Clene Inc. announced the completion of FDA-recommended biomarker analyses for its investigational therapy CNM-Au8® in people living with amyotrophic lateral sclerosis (ALS). The results, which have already been completed, demonstrate statistically significant reductions in neurofilament light (NfL) and glial fibrillary acidic protein (GFAP) in participants treated with CNM-Au8. These biomarker improvements are reported to be strongly associated with longer survival. Clene plans to present the full dataset to the FDA in a Type C meeting anticipated for the first quarter of 2026, as part of its strategy to submit a New Drug Application (NDA) under the accelerated approval pathway. The planned Phase 3 RESTORE-ALS trial will serve as the post-approval confirmatory study. The company is hosting an investor webcast to provide an update on the CNM-Au8 program. Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Clene Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9595857-en) on December 03, 2025, and is solely responsible for the information contained therein. © Copyright 2025 - Public Technologies (PUBT)