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This article was published by IBN, a multifaceted communications organization engaged in connecting public companies to the investment community.
LOS ANGELES - (NewMediaWire) - December 11, 2024 - Clene (NASDAQ: CLNN) received FDA guidance on leveraging data from its ongoing expanded access programs ("EAPs") to support an accelerated approval application for CNM-Au8, its treatment for ALS. The FDA recommended using neurofilament light chain ("NfL") biomarker analyses to substantiate the drug's efficacy. Clene plans to submit additional data in mid-2025, alongside commencing the Phase 3 RESTORE-ALS trial. Clinical findings presented at an FDA meeting highlighted CNM-Au8's significant survival benefits and benign safety profile, underscoring its potential as a transformative ALS therapy. Clene remains committed to addressing the urgent unmet needs of ALS patients.
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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.
Forward-Looking Statements
Certain statements in this article are forward-looking, as defined in the Private Securities Litigation Reform Act of 1995. These statements involve risks, uncertainties, and other factors that may cause actual results to differ materially from the information expressed or implied by these forward-looking statements and may not be indicative of future results. These forward-looking statements are subject to a number of risks and uncertainties, including, among others, various factors beyond management's control, including the risks set forth under the heading "Risk Factors" discussed under the caption "Item 1A. Risk Factors" in Part I of the Company's most recent Annual Report on Form 10-K or any updates discussed under the caption "Item 1A. Risk Factors" in Part II of the Company's Quarterly Reports on Form 10-Q and in the Company's other filings with the SEC. Undue reliance should not be placed on the forward-looking statements in this article in making an investment decision, which are based on information available to us on the date hereof. All parties undertake no duty to update this information unless required by law.