BioMedNewsBreaks — 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.”

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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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