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LOS ANGELES, CA - 
(NewMediaWire) - September 26, 2024 - 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®.
● 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.
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