QualityStocksNewsBreaks – Clene Inc. (NASDAQ: CLNN) Receives FDA Roadmap on Potential Accelerated Pathway for CNM-Au8(R)
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”), recently 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. “The FDA guidance on a potential path to meet the regulatory standard for substantial evidence of effectiveness supporting accelerated approval came following an in-person Nov. 1 Type C meeting with…