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Clene submits New Drug Application to FDA for CNM-Au8 to treat ALS
CLNNClene Inc.
Clene Inc. submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration seeking accelerated approval of CNM-Au8 for the treatment of amyotrophic lateral sclerosis (ALS). The submission is based on neurofilament light chain biomarker data and clinical outcomes. Clene remains focused on advancing CNM-Au8 through the regulatory process while preparing for a confirmatory Phase 3 RESTORE-ALS study. Clene Inc. is a late clinical-stage biopharmaceutical company focused on improving mitochondrial health to treat neurodegenerative diseases.