NetworkNewsBreaks – Clene Inc. (NASDAQ: CLNN) Lo
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Posted On: 04/11/2024 6:02:23 PM
NetworkNewsBreaks – Clene Inc. (NASDAQ: CLNN) Looking to Advance Discussions for Accelerated Approval, New NDA for CNM-Au8(R) in 2024
Clene (NASDAQ: CLNN), alongside its wholly owned subsidiary Clene Nanomedicine Inc., is a clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases. These include amyotrophic lateral sclerosis (“ALS”) and multiple sclerosis (“MS”). “Clene’s lead candidate, CNM-Au8(R), is a gold nanocrystal suspension that has emerged as a promising candidate for the treatment of both ALS and MS… Despite the FDA’s decision in late 2023 against allowing Clene to move forward with an accelerated approval pathway based on initial biomarker data, Clene is diligently preparing supplemental data to provide additional supportive biomarker, survival and mechanistic data, to advance discussions for accelerated approval and a new drug application (‘NDA’) in 2024,” reads a recent article. “Having held our initial discussion with the FDA in the fourth quarter of last year, we have a clear understanding of the additional data required to support an accelerated approval pathway filing for CNM-Au8,” said Rob Etherington, president and CEO of Clene. “We believe that we can provide additional supportive evidence to advance discussions with the FDA with the potential to file an NDA later this year.”
ww.Clene.com.
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), alongside its wholly owned subsidiary Clene Nanomedicine Inc., is a clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases. These include amyotrophic lateral sclerosis (“ALS”) and multiple sclerosis (“MS”). “Clene’s lead candidate, CNM-Au8(R), is a gold nanocrystal suspension that has emerged as a promising candidate for the treatment of both ALS and MS… Despite the FDA’s decision in late 2023 against allowing Clene to move forward with an accelerated approval pathway based on initial biomarker data, Clene is diligently preparing supplemental data to provide additional supportive biomarker, survival and mechanistic data, to advance discussions for accelerated approval and a new drug application (‘NDA’) in 2024,” reads a recent article. “Having held our initial discussion with the FDA in the fourth quarter of last year, we have a clear understanding of the additional data required to support an accelerated approval pathway filing for CNM-Au8,” said Rob Etherington, president and CEO of Clene. “We believe that we can provide additional supportive evidence to advance discussions with the FDA with the potential to file an NDA later this year.”
ww.Clene.com.
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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