Clene Inc. (Nasdaq: CLNN) announced on October 19, 2026, that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its investigational treatment candidate, CNM-Au8, for the condition amyotrophic lateral sclerosis (ALS). The company stated that the submission seeks accelerated approval of the therapy.
According to the filing, the NDA is supported by data regarding neurofilament light chain biomarkers and clinical outcomes. The company noted that the submission reflects years of work by the Clene team, clinical investigators, patients, and families.
Rob Etherington, President and Chief Executive Officer of Clene, commented on the submission, stating, “We appreciate the FDA’s constructive engagement throughout this process and look forward to working closely with the Agency during its review.” He added that the company remains focused on advancing CNM-Au8 through the regulatory process while preparing for the confirmatory Phase 3 RESTORE-ALS study.
Clene Inc. is a clinical-stage biotechnology company based in Salt Lake City, Utah, with R&D and manufacturing operations in Maryland. The company focuses on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including ALS, Parkinson’s disease, and multiple sclerosis.
