Clene Announces New Drug Application Submission to FDA for CNM-Au8 for the Treatment of ALS

NDA submission seeks accelerated approval of CNM-Au8 based on neurofilament light chain biomarker data and clinical outcomes SALT LAKE CITY, Oct. 19, 2026 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN), a clinical-stage biotechnology company focused on revolutionizing the treatment of neurodegenerative diseases, announced that it has submitted a New Drug Application (NDA) earlier in October to the U.S. Food and Drug Administration (FDA) seeking accelerated approval of CNM-Au8® for the treatment o