Clene Inc. Advances ALS Treatment CNM-Au8 Toward FDA Submission with Extended Financial Runway
TL;DR
Clene Inc. plans to submit an NDA for CNM-Au8 in ALS by end-2025, potentially gaining first-mover advantage in neurodegenerative treatments.
Clene will submit an NDA for CNM-Au8 in ALS after FDA meetings in Q3 2025 and neurofilament light data analysis in early Q4 2025.
CNM-Au8 aims to treat ALS and MS by improving mitochondrial health, offering hope for better neurodegenerative disease management.
Clene's gold nanocrystal oral suspension enhances neuronal energy metabolism, with key regulatory milestones set through 2025.
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Clene Inc. (NASDAQ: CLNN) has announced its second quarter 2025 financial results while outlining critical milestones for its neurodegenerative disease treatment programs. The biopharmaceutical company confirmed plans to submit a New Drug Application for its lead candidate CNM-Au8® in amyotrophic lateral sclerosis by the end of 2025, marking a significant advancement in the treatment landscape for this devastating condition.
The company has scheduled FDA meetings for the third quarter of 2025 to address ALS survival benefit data and multiple sclerosis development plans. These regulatory discussions will be crucial for determining the path forward for CNM-Au8, an oral suspension of gold nanocrystals designed to restore neuronal health by improving energy metabolism. The treatment represents a novel approach to addressing mitochondrial dysfunction in neurodegenerative diseases.
Additional biomarker data analysis from the NIH-sponsored Expanded Access Program is expected in early fourth quarter 2025. The neurofilament light biomarker data will provide further evidence of CNM-Au8's potential efficacy in slowing disease progression. Clene recently held a Type C meeting with the FDA to align on statistical methodology for analyzing these biomarker changes, ensuring rigorous scientific standards are maintained throughout the development process.
Financially, the company reported $7.3 million in cash and cash equivalents as of June 30, 2025, with recent financing extending the company's cash runway into the first quarter of 2026. This financial stability provides the necessary resources to complete the NDA submission process and continue clinical development activities. The extended runway demonstrates investor confidence in the company's pipeline and strategic direction.
The progress toward regulatory submission for CNM-Au8 is particularly significant given the limited treatment options currently available for ALS patients. Successful development of this therapy could address a substantial unmet medical need and provide new hope for patients suffering from this progressive neurodegenerative disease. The company's focus on mitochondrial health and neuronal protection represents an innovative approach to treating conditions that have historically proven difficult to address with conventional pharmaceutical approaches.
Clene's advancement of CNM-Au8 through the regulatory process, combined with its strengthened financial position, positions the company to potentially bring a new treatment option to market for ALS patients. The upcoming FDA meetings and biomarker data analysis will be critical determinants in the therapy's development timeline and eventual market approval pathway.
Curated from InvestorBrandNetwork (IBN)
