SALT LAKE CITY, October 19, 2026 — 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 of amyotrophic lateral sclerosis (ALS).
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Program / event
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CNM-Au8Submission
earlier in October
“SALT LAKE CITY, October 19, 2026 — 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 of amyotrophic lateral sclerosis (ALS).”
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A New Drug Application (NDA) or Biologics License Application (BLA) asks the FDA to approve a drug or biologic for sale.A Form 8-K is a report a company files with the SEC to announce a significant event between its regular reports.