Clene Inc. is making significant strides in its neurological disease treatment strategy, with its investigational therapy CNM-Au8 showing promising results for patients with amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS).
The biopharmaceutical company reported first quarter financial results and key developments in its CNM-Au8 program. Most notably, Clene is preparing for a potential New Drug Application (NDA) submission under the FDA’s Accelerated Approval pathway for ALS in the fourth quarter of 2025. This preparation is supported by compelling survival data and anticipated biomarker analysis.
Recent data revealed that CNM-Au8 significantly improved survival rates in patients with more advanced stages of ALS. In the multiple sclerosis treatment arena, the company presented Phase 2 extension results demonstrating potential for remyelination and neuronal repair.
Financially, Clene reported a net loss of $0.8 million for the first quarter, accompanied by $9.8 million in cash reserves, which are projected to fund operations through the third quarter of 2025. The company’s CNM-Au8 therapy is designed to improve central nervous system cell survival and function by targeting mitochondrial function and the NAD pathway while reducing oxidative stress.
The potential approval of CNM-Au8 represents a significant advancement in neurological disease treatment, particularly for ALS patients who currently have limited therapeutic options. By focusing on improving mitochondrial health and neuronal function, Clene is addressing critical unmet medical needs in neurodegenerative conditions.
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