Blockchain Registration Transaction Record

Clene Advances CNM-Au8 Toward FDA Submission for ALS Treatment

Clene Inc. plans NDA submission for CNM-Au8 in ALS by end of 2025. FDA meetings scheduled, neurofilament data expected Q4. $7.3M cash extends runway to 2026.

This development matters because ALS (amyotrophic lateral sclerosis) is a devastating neurodegenerative disease with limited treatment options and no cure. Current therapies primarily address symptoms rather than slowing disease progression. If CNM-Au8 receives FDA approval, it could represent the first treatment that actually improves neuronal function and survival for ALS patients. The neurofilament light biomarker data being analyzed could provide objective evidence of neuroprotection, which would be a significant breakthrough in neurology. For the approximately 30,000 Americans living with ALS and their families, this represents hope for extended survival and improved quality of life. The financial stability indicated by the extended cash runway into 2026 suggests Clene has the resources to see this through regulatory review, making this more than just another experimental treatment—it's a potentially viable near-term solution for a disease that has seen few therapeutic advances in decades.