• The company is seeking an accelerated approval regulatory pathway for CNM-Au8® for ALS.
• The FDA agreed to an in-person meeting to reevaluate Clene’s submission.
• Lead drug candidate CNM-Au8 has been shown to restore and protect neurological function, offering hope for patients with neurodegenerative conditions.
• The FDA meeting will be held before the end of November and will be attended by top FDA officials and key opinion leaders in ALS, biostatistics and biomarkers.

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”), announced an upcoming meeting with the U.S. Food and Drug Administration (“FDA”) leadership to discuss lead candidate CNM-Au8®.

According to a company press release, the in-person meeting will be held before the end of November 2024 and will focus on the company’s CNM-Au8 biomarker and related clinical and survival data for ALS. The meeting will be attended by FDA’s Director of the Office on New Drugs, the Director of the Office of…

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