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Posted On: 10/24/2024 4:53:22 PM
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NetworkNewsBreaks – Clene Inc. (NASDAQ: CLNN) Set to Discuss Lead Candidate Biomarker with FDA Leadership
Clene (NASDAQ: CLNN) and its wholly owned subsidiary Clene Nanomedicine Inc., a late clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis (“ALS”) and multiple sclerosis (“MS”), recently announced an upcoming meeting with U.S. Food and Drug Administration (“FDA”) leadership. The focus is to discuss Clene’s CNM-Au8® biomarker and related clinical and survival data for ALS. “FDA’s Director of the Office on New Drugs, the Director of the Office of Neuroscience, and the Division of Neurology 1 (‘DN1’) review team, as well as recognized key opinion leaders in ALS, biostatistics and biomarkers,” will attend the meeting according to a recent article.
“Clene looks forward to the opportunity to have experts present their views to the FDA and address questions on ALS biomarkers, related clinical endpoints and survival data, all of which Clene believes are essential for the understanding of its CNM-Au8,” the company stated in a news release. Clene also voiced appreciation for the FDA’s use of process and regulatory flexibility to obtain the best outcome for people living with ALS.
NOTE TO INVESTORS: The latest news and updates relating to CLNN are available in the company’s newsroom at https://ibn.fm/CLNN
Please see full terms of use and disclaimers on the NetworkNewsWire website applicable to all content provided by NNW, wherever published or republished: http://NNW.fm/Disclaimer
Clene (NASDAQ: CLNN) and its wholly owned subsidiary Clene Nanomedicine Inc., a late clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis (“ALS”) and multiple sclerosis (“MS”), recently announced an upcoming meeting with U.S. Food and Drug Administration (“FDA”) leadership. The focus is to discuss Clene’s CNM-Au8® biomarker and related clinical and survival data for ALS. “FDA’s Director of the Office on New Drugs, the Director of the Office of Neuroscience, and the Division of Neurology 1 (‘DN1’) review team, as well as recognized key opinion leaders in ALS, biostatistics and biomarkers,” will attend the meeting according to a recent article.
“Clene looks forward to the opportunity to have experts present their views to the FDA and address questions on ALS biomarkers, related clinical endpoints and survival data, all of which Clene believes are essential for the understanding of its CNM-Au8,” the company stated in a news release. Clene also voiced appreciation for the FDA’s use of process and regulatory flexibility to obtain the best outcome for people living with ALS.
NOTE TO INVESTORS: The latest news and updates relating to CLNN are available in the company’s newsroom at https://ibn.fm/CLNN
Please see full terms of use and disclaimers on the NetworkNewsWire website applicable to all content provided by NNW, wherever published or republished: http://NNW.fm/Disclaimer
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