Clene Inc. (NASDAQ: CLNN) Receives FDA Guidance On Accelerated Approval Pathway For CNM-Au8(R) For ALS

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• The FDA asked for additional Neurofilament Light (“NfL”) data from the company's three Expanded Access Protocols to support earlier clinical trial findings.
• The company has already begun collecting and analyzing this data, with plans to complete the process in Q2 2025 and then submit a New Drug Application (“NDA”) for CNM-Au8 by mid-2025.
• A follow-up meeting with the FDA will be held early next year to discuss and finalize the statistical analysis plan for the EAP NFL biomarker analyses.
• The company is meanwhile preparing a confirmatory Phase 3 trial (“RESTORE-ALS”) to evaluate the survival benefit of CNM-Au8 with initial participant enrollment set to begin before NDA submission.

Clene (NASDAQ: CLNN)
and its wholly owned subsidiary, Clene Nanomedicine Inc., a late clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis (“ALS”) and multiple sclerosis (“MS”), has received additional written guidance and a roadmap from the U.S. Food and Drug Administration's (“FDA”) Division of Neurology 1 regarding a potential accelerated approval pathway for lead drug candidate CNM-Au8 in ALS ( ).

CNM-Au8, an oral suspension of gold nanocrystals, works by improving cellular energy production and utilization, which is critical for maintaining neuronal health. The drug candidate has already been shown to improve central nervous system cells' survival and function via a mechanism that targets...

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