Curated News
By: NewsRamp Editorial Staff
July 25, 2025
Clene Advances ALS Treatment with FDA-Backed Biomarker Analysis
TLDR
- Clene Inc.'s upcoming neurofilament biomarker analyses for CNM-Au8 in ALS could position it as a leader in neurodegenerative disease treatment, offering a competitive edge in biopharmaceutical innovation.
- Clene Inc. will conduct neurofilament biomarker analyses in Q4 2025 to evaluate CNM-Au8's impact on neurodegeneration in ALS patients, following FDA feedback and a structured plan.
- Clene Inc.'s research into CNM-Au8 for ALS and MS represents hope for improving lives by advancing treatments for debilitating neurodegenerative diseases.
- Clene Inc. is exploring how CNM-Au8 affects neurodegeneration in ALS, a groundbreaking step towards understanding and treating complex neurological conditions.
Impact - Why it Matters
This news is significant as it highlights a critical step forward in the treatment of ALS and other neurodegenerative diseases. The FDA's support for Clene's biomarker analysis underscores the potential of CNM-Au8(R) to offer a new therapeutic avenue for patients with limited treatment options. The focus on neurofilament light chain as a biomarker could also pave the way for more personalized and effective treatments, marking a pivotal moment in neurodegenerative disease research.
Summary
Clene Inc. (NASDAQ: CLNN), a late clinical-stage biopharmaceutical company, is set to begin neurofilament biomarker analyses for its lead drug candidate, CNM-Au8(R), in ALS patients. This initiative follows constructive feedback from the FDA during a recent Type C meeting. The analyses, expected to start in early Q4 2025, will focus on measuring changes in neurofilament light chain (NfL), a key indicator of neurodegeneration, in nearly 200 patients participating in the Expanded Access Program for CNM-Au8. Dr. Benjamin Greenberg, Clene's Head of Medical, expressed optimism about the FDA's collaborative stance and highlighted upcoming meetings to discuss long-term ALS survival results and End-of-Phase 2 MS results. Clene is dedicated to developing innovative therapies for neurodegenerative diseases, including ALS, Parkinson's disease, and multiple sclerosis, with CNM-Au8(R) representing a first-in-class therapy aimed at enhancing mitochondrial health and neuronal function.
For more details, visit the full article. Clene's commitment to advancing treatment options for neurodegenerative diseases is further underscored by its operations in Salt Lake City, Utah, and Maryland. Investors and interested parties can stay updated on Clene's progress through its newsroom at https://ibn.fm/CLNN.
Source Statement
This curated news summary relied on content disributed by InvestorBrandNetwork (IBN). Read the original source here, Clene Advances ALS Treatment with FDA-Backed Biomarker Analysis
