Clene Announces New Drug Application Submission to FDA for CNM-Au8 for the Treatment of ALS
Key Highlights
- ➤Clene submitted an FDA NDA for CNM-Au8 in October seeking accelerated ALS approval
- ➤CNM-Au8 submission relies on neurofilament light chain biomarker data and clinical outcomes
- ➤Clene is preparing the confirmatory Phase 3 RESTORE-ALS study
Expert Statements
Rob Etherington, President and Chief Executive Officer of Clene
“The submission of our NDA for CNM-Au8 represents an important achievement for Clene, CNM-Au8, and especially for people living with ALS.”
Rob Etherington, President and Chief Executive Officer of Clene
“We appreciate the FDA’s constructive engagement throughout this process and look forward to working closely with the Agency during its review.”
Rob Etherington, President and Chief Executive Officer of Clene
“Reaching this stage reflects years of dedicated work by the Clene team, our clinical investigators, patients and families, and our partners,”
Rob Etherington, President and Chief Executive Officer of Clene
“We remain focused on advancing CNM-Au8 through the regulatory process as efficiently as possible while continuing our preparations for the confirmatory Phase 3 RESTORE-ALS study.”
Rob Etherington, President and Chief Executive Officer of Clene
“People living with ALS urgently need additional treatment options, and we believe CNM-Au8 has the potential to restore and protect neuronal health and function and improve survival.”
* 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 of amyotrophic lateral sclerosis (ALS).
“The submission of our NDA for CNM-Au8 represents an important achievement for Clene, CNM-Au8, and especially for people living with ALS,” said Rob Etherington, President and Chief Executive Officer of Clene. “We appreciate the FDA’s constructive engagement throughout this process and look forward to working closely with the Agency during its review.”
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