On September 16, 2024, Clene Inc., a late-stage biopharmaceutical company, announced an upcoming in-person meeting with the U.S. Food and Drug Administration (FDA) to discuss the CNM-Au8 biomarker and related clinical and survival data. The meeting, scheduled before the end of November 2024, will involve senior FDA officials and key opinion leaders in the field of amyotrophic lateral sclerosis (ALS). This follows a recent communication from the FDA's Division of Neurology 1 (DN1) indicating that Clene's briefing package was initially not supportive of an accelerated approval pathway for CNM-Au8. However, subsequent discussions led to the FDA agreeing to re-evaluate the submission. Clene aims to present expert views on ALS biomarkers and related clinical endpoints during the meeting. The company has gathered over 700 patient-years of safety data for CNM-Au8, with no significant safety concerns or serious adverse events related to the treatment reported. Clene focuses on developing treatments for neurodegenerative diseases by improving mitochondrial health and protecting neuronal function.

On September 16, 2024, Clene Inc., a late-stage biopharmaceutical company, announced an upcoming in-person meeting with the U.S. Food and Drug Administration (FDA) to discuss the CNM-Au8 biomarker and related clinical and survival data. The meeting, scheduled before the end of November 2024, will involve senior FDA officials and key opinion leaders in the field of amyotrophic lateral sclerosis (ALS). This follows a recent communication from the FDA's Division of Neurology 1 (DN1) indicating that Clene's briefing package was initially not supportive of an accelerated approval pathway for CNM-Au8. However, subsequent discussions led to the FDA agreeing to re-evaluate the submission. Clene aims to present expert views on ALS biomarkers and related clinical endpoints during the meeting. The company has gathered over 700 patient-years of safety data for CNM-Au8, with no significant safety concerns or serious adverse events related to the treatment reported. Clene focuses on developing treatments for neurodegenerative diseases by improving mitochondrial health and protecting neuronal function.