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Posted On: 12/26/2024 3:36:53 PM
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NetworkNewsBreaks – Clene Inc. (NASDAQ: CLNN) Receives FDA Roadmap on Potential Accelerated Pathway for CNM-Au8(R)
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 received additional written guidance and a roadmap from the U.S. Food and Drug Administration’s (“FDA”) Division of Neurology 1 regarding a potential accelerated approval pathway for lead drug candidate CNM-Au8 in ALS. “The FDA guidance on a potential path to meet the regulatory standard for substantial evidence of effectiveness supporting accelerated approval came following an in-person Nov. 1 Type C meeting with the DN1 where the company presented additional clinical trial data and analyses. The FDA recommended that Clene leverage additional Neurofilament Light (‘NfL’) data from its three Expanded Access Programs (‘EAPs’) to support earlier findings,” reads an article discussing the guidance.
“Together with the survival and supportive biomarker data generated thus far, the drug’s benign safety profile, and the emerging EAP NfL data, we look forward to continued discussions with the Agency,” said Clene’s CEO and President, Rob Etherington. “Clene plans to include the additional data in an NDA submission under the accelerated approval pathway in mid-2025. We remain dedicated to the ALS community and honored to help critically ill patients and their families.”
NOTE TO INVESTORS: The latest news and updates relating to CLNN are available in the company’s newsroom at https://nnw.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 received additional written guidance and a roadmap from the U.S. Food and Drug Administration’s (“FDA”) Division of Neurology 1 regarding a potential accelerated approval pathway for lead drug candidate CNM-Au8 in ALS. “The FDA guidance on a potential path to meet the regulatory standard for substantial evidence of effectiveness supporting accelerated approval came following an in-person Nov. 1 Type C meeting with the DN1 where the company presented additional clinical trial data and analyses. The FDA recommended that Clene leverage additional Neurofilament Light (‘NfL’) data from its three Expanded Access Programs (‘EAPs’) to support earlier findings,” reads an article discussing the guidance.
“Together with the survival and supportive biomarker data generated thus far, the drug’s benign safety profile, and the emerging EAP NfL data, we look forward to continued discussions with the Agency,” said Clene’s CEO and President, Rob Etherington. “Clene plans to include the additional data in an NDA submission under the accelerated approval pathway in mid-2025. We remain dedicated to the ALS community and honored to help critically ill patients and their families.”
NOTE TO INVESTORS: The latest news and updates relating to CLNN are available in the company’s newsroom at https://nnw.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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