Clene Inc. (NASDAQ: CLNN) and its subsidiary Clene Nanomedicine Inc. have reported significant progress toward submitting a New Drug Application for their lead asset CNM-Au8® in treating amyotrophic lateral sclerosis. The company anticipates submitting the NDA in the fourth quarter of 2025 under the accelerated approval pathway, marking a critical milestone in developing treatments for this devastating neurodegenerative disease.
CEO Rob Etherington emphasized the company's upcoming engagement with the FDA, stating that meetings and biomarker analyses represent the final steps toward potential submission. The extensive survival data generated by CNM-Au8® in ALS patients forms the foundation of their regulatory approach. This development is particularly significant given the urgent need for effective ALS treatments and the devastating impact of the disease on patients and families.
CNM-Au8® represents a first-in-class investigational therapy that operates through a novel mechanism targeting mitochondrial function and the NAD pathway while reducing oxidative stress. The therapy aims to improve central nervous system cells' survival and function, addressing fundamental aspects of neurodegenerative diseases. For more detailed information about the company's technology and approach, visit https://www.Clene.com.
The progress toward NDA submission holds substantial implications for the ALS community and the broader neurodegenerative disease treatment landscape. Successful approval could provide a new therapeutic option for ALS patients, potentially slowing disease progression and improving survival outcomes. The accelerated approval pathway utilization demonstrates the treatment's potential to address unmet medical needs in this challenging disease area.
Investors and stakeholders can access the latest updates and news relating to CLNN through the company's newsroom at https://ibn.fm/CLNN. The company's commitment to developing impactful therapeutic agents for neurodegenerative diseases remains unwavering as they approach this critical regulatory milestone.
