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Edge12 Dec 2025
Running on Clouds: The Story of On
The story of how a Swiss runner's pursuit of a new running sensation became On, aiming to be the most premium global sportswear brand worldwide.
Clene (CLNN) investor relations material
Clene Emerging Growth Conference 88 summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Emerging Growth Conference 88 summary10 Dec, 2025
Company overview and strategy
Focuses on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, particularly ALS.
Engaged in ongoing discussions with the FDA regarding biomarker data for accelerated approval of lead asset CNM-Au8.
Pursuing a multi-pronged approach to validate biomarker data, including new data from the Healey Harvard program.
Preparing a comprehensive dossier for FDA review in the first quarter.
Biomarker data and regulatory pathway
Biomarkers neurofilament light chain and GFAP are being used to demonstrate neuronal damage and treatment efficacy.
Statistically significant reductions in both biomarkers observed with CNM-Au8 treatment.
Correlation established between neurofilament light chain levels and survival outcomes.
FDA has outlined a path for accelerated approval based on biomarker endpoints.
Next steps and timeline
Meeting with the FDA scheduled for the first quarter to discuss the data and next steps.
New Drug Application (NDA) preparation underway, targeting submission in the first half of the year.
Potential for commercialization decision in late 2026 or early 2027, pending FDA alignment.
Confirmatory phase 3 study to commence in 2026, focusing on survival as the primary endpoint.
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Next Clene earnings date
Q4 202513 Mar, 2026
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Frequently asked questions
Clene Inc. is a biopharmaceutical company focused on developing nanotechnology-based therapies for neurodegenerative diseases. The company specializes in therapeutic candidates targeting conditions such as amyotrophic lateral sclerosis (ALS), multiple sclerosis (MS), and Parkinson’s disease. Its lead programs utilize proprietary nanocrystal technology to enhance cellular energy production and neuroprotection. The company is headquartered in Salt Lake City, Utah, and its shares are listed on the NASDAQ.
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