Curated News
By: NewsRamp Editorial Staff
September 09, 2025
Clene Advances CNM-Au8® for ALS, Eyes 2025 FDA Submission
TLDR
- Clene's CNM-Au8 shows promise for ALS treatment, potentially offering investors early advantage in neurodegenerative disease therapeutics ahead of Q4 2025 NDA submission.
- CNM-Au8 improves mitochondrial function and reduces oxidative stress through NAD pathway targeting, with NDA submission planned via accelerated approval pathway by end 2025.
- This therapy could significantly improve quality of life for ALS patients by protecting neuronal function and addressing this devastating neurodegenerative disease.
- Clene's gold nanocrystal therapy represents a novel approach to treating ALS by enhancing cellular energy production and survival mechanisms in the nervous system.
Impact - Why it Matters
This development is crucial because ALS is a progressive and fatal neurodegenerative disease with limited treatment options, affecting thousands of patients globally. If approved, CNM-Au8® could offer a novel therapeutic approach that improves mitochondrial function and neuronal survival, potentially slowing disease progression and enhancing quality of life. For investors and the biopharmaceutical industry, Clene's progress signifies innovation in tackling challenging diseases, while patients and families gain hope for more effective treatments amid high unmet medical needs.
Summary
Clene Inc. (NASDAQ: CLNN) and its subsidiary Clene Nanomedicine Inc., a late clinical-stage biopharmaceutical company focused on neurodegenerative diseases, recently announced their second quarter 2025 financial results and provided significant updates on their clinical programs. The company highlighted substantial progress toward submitting a New Drug Application (NDA) for their lead asset CNM-Au8® in treating amyotrophic lateral sclerosis (ALS), with expectations to file by the fourth quarter of 2025. CEO Rob Etherington emphasized upcoming engagements with the FDA to discuss extensive survival data generated from ALS patients, marking critical final steps toward potential accelerated approval.
CNM-Au8® represents a first-in-class investigational therapy designed to improve mitochondrial health and protect neuronal function by targeting mitochondrial efficiency and the NAD pathway while reducing oxidative stress. This innovative approach aims to address devastating neurodegenerative conditions such as ALS, Parkinson's disease, and multiple sclerosis. Based in Salt Lake City, Utah, with R&D and manufacturing operations in Maryland, Clene is committed to developing impactful therapeutics, as detailed in their recent updates available through the InvestorBrandNetwork and additional resources like their newsroom.
The news release was disseminated by MissionIR, part of the Dynamic Brand Portfolio at IBN, which specializes in enhancing corporate visibility through syndicated content, press release enhancement, and social media distribution. For more in-depth information, readers can access the full article and related updates through provided hyperlinks, ensuring comprehensive coverage of Clene's advancements and their potential implications for patients and investors alike.
Source Statement
This curated news summary relied on content disributed by InvestorBrandNetwork (IBN). Read the original source here, Clene Advances CNM-Au8® for ALS, Eyes 2025 FDA Submission
