Clene (NASDAQ: CLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine Inc., a clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, today announced its full year 2023 financial results. In addition, the company provided recent operating highlights for the clinical programs in amyotrophic lateral sclerosis (“ALS”) and multiple sclerosis (“MS”). “In 2024 we will continue to advance our regulatory discussions with the U.S. Food and Drug Administration (‘FDA’) that we anticipate will include new data on biomarkers, as well as additional clinical function and survival data in people living with ALS,” said Rob Etherington, president and CEO of Clene. “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(R). 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.”
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About Clene Inc.
Clene (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine Inc., is a late clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis, Parkinson’s disease and multiple sclerosis. CNM-Au8(R) is an investigational first-in-class therapy that improves central nervous system cells’ survival and function via a mechanism that targets mitochondrial function and the NAD pathway while reducing oxidative stress. CNM-Au8(R) is a federally registered trademark of Clene Nanomedicine, Inc. The company is based in Salt Lake City, Utah, with R&D and manufacturing operations in Maryland. For more information, please visit www.Clene.com.
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