Curated News
By: NewsRamp Editorial Staff
October 25, 2024
Clene (CLNN) to Meet with FDA to Discuss ALS Biomarker and Clinical Data
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- Clene Inc. plans to discuss CNM-Au8 biomarker and clinical data for ALS with FDA leadership, gaining a potential edge in treating neurodegenerative diseases.
- CNM-Au8 is an investigational therapy targeting mitochondrial function and the NAD pathway to improve neuronal function and treat neurodegenerative diseases.
- The meeting with FDA aims to improve understanding of CNM-Au8 for the treatment of ALS, potentially offering hope to people living with the disease.
- Clene's focus on improving mitochondrial health and protecting neuronal function through CNM-Au8 therapy may revolutionize treatment for neurodegenerative diseases.
Impact - Why it Matters
This news matters because it highlights Clene's efforts to address neurodegenerative diseases like ALS. The outcome of the meeting could impact the understanding and treatment of ALS, potentially benefiting patients with the condition.
Summary
Clene (NASDAQ: CLNN) and its subsidiary Clene Nanomedicine Inc. are set to meet with FDA leadership to discuss the CNM-Au8 biomarker and related clinical data for ALS. The meeting will include key opinion leaders in ALS, biostatistics, and biomarkers, as well as FDA officials.
Clene is eager to present their experts' views to the FDA and address questions on ALS biomarkers, clinical endpoints, and survival data, which they believe are crucial for understanding CNM-Au8. The company also expressed gratitude for the FDA's flexibility in the regulatory process to benefit ALS patients.
For more information, visit https://ibn.fm/3O2Zt
Source Statement
This curated news summary relied on this press release disributed by InvestorBrandNetwork (IBN). Read the source press release here, Clene (CLNN) to Meet with FDA to Discuss ALS Biomarker and Clinical Data
