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

  • Clene Inc. submitted a New Drug Application (NDA) to the FDA in October 2026 seeking accelerated approval for CNM-Au8 to treat amyotrophic lateral sclerosis (ALS).
  • The NDA submission is based on neurofilament light chain biomarker data & clinical outcomes.
  • Clene plans to continue preparations for the confirmatory Phase 3 RESTORE-ALS study while the FDA reviews the application.
  • CNM-Au8 is a first-in-class investigational therapy that targets mitochondrial function & the NAD pathway to reduce oxidative stress & improve neuronal survival.
  • The company is based in Salt Lake City, Utah, with R&D & manufacturing operations in Maryland.