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Posted On: 08/06/2024 4:08:43 PM
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NetworkNewsBreaks – Clene Inc. (NASDAQ: CLNN) Submits New CNM-Au8 Biomarker, Clinical Efficacy Data to FDA
Clene (NASDAQ: CLNN), a late-stage biopharmaceutical company focused on protecting mitochondrial health and neuronal function to treat neurodegenerative diseases, and its wholly owned subsidiary Clene Nanomedicine Inc., have submitted new data to the U.S. Food and Drug Administration (“FDA”). The data is regarding CNM-Au8(R) biomarker and clinical efficacy information, including post hoc analyses from two phase 2 clinical trials of CNM-Au8 for the treatment of ALS; the trials were conducted independently.
According to the announcement, this new data is in addition to original data the company has discussed with FDA and is intended to guide the planned FDA Type C interaction; that interaction is expected to take place in the Q3 2024 and will include discussion about an accelerated approval regulatory pathway.
Clene Nanomedicine is a clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurological diseases, including amyotrophic lateral sclerosis (“ALS”) and multiple sclerosis (“MS”).
“The risk-benefit assessment evidence of CNM-Au8 is strong,” said Clene CEO and president Rob Etherington in the press release. “Our next step is discussing this new CNM-Au8 biomarker and efficacy data with the FDA, with the hope that ALS patients will benefit from this drug, sooner rather than later.”
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), a late-stage biopharmaceutical company focused on protecting mitochondrial health and neuronal function to treat neurodegenerative diseases, and its wholly owned subsidiary Clene Nanomedicine Inc., have submitted new data to the U.S. Food and Drug Administration (“FDA”). The data is regarding CNM-Au8(R) biomarker and clinical efficacy information, including post hoc analyses from two phase 2 clinical trials of CNM-Au8 for the treatment of ALS; the trials were conducted independently.
According to the announcement, this new data is in addition to original data the company has discussed with FDA and is intended to guide the planned FDA Type C interaction; that interaction is expected to take place in the Q3 2024 and will include discussion about an accelerated approval regulatory pathway.
Clene Nanomedicine is a clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurological diseases, including amyotrophic lateral sclerosis (“ALS”) and multiple sclerosis (“MS”).
“The risk-benefit assessment evidence of CNM-Au8 is strong,” said Clene CEO and president Rob Etherington in the press release. “Our next step is discussing this new CNM-Au8 biomarker and efficacy data with the FDA, with the hope that ALS patients will benefit from this drug, sooner rather than later.”
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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