- Clene is progressing toward a potential FDA accelerated approval for its ALS (Amyotrophic Lateral Sclerosis) drug CNM-Au8® in 2026, a market that is expected to reach $1.3 billion by 2034 with significant unmet need.
- Clene’s technology targets mitochondrial dysfunction, a novel approach to neurodegenerative diseases, and key FDA meetings in the coming months of 2025 could be major valuation catalysts for investors.
- Biomarker and survival data from over 150 patients will be critical to the company’s regulatory case and expects important NfL data in the fourth quarter of 2025.
- Clene is preparing to initiate a confirmatory Phase 3 ALS trial in the first half of 2026, with a separate MS (multiple sclerosis) program in late-stage development.
Investors looking for exposure to important biopharma innovation in underserved markets need to consider Clene (NASDAQ: CLNN). Clene and its wholly owned subsidiary, Clene Nanomedicine Inc., a late clinical-stage biopharmaceutical company is focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis (“ALS”) and multiple sclerosis (“MS”). The company is advancing its lead candidate CNM-Au8®, a unique and needed oral treatment for ALS, toward a potential FDA accelerated approval.
Clene’s primary value proposition lies in its differentiated mechanism of action and its potential to secure a meaningful share of the large and growing ALS treatment market. CNM-Au8 is a suspension of gold nanocrystals designed to enhance mitochondrial function and protect neurons, an approach that targets…
NOTE TO INVESTORS: The latest news and updates relating to CLNN are available in the company’s newsroom at https://ibn.fm/CLNN
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