Clene Inc. Advances Promising ALS Treatment Toward FDA Accelerated Approval

Neurodegenerative disease treatment may see a significant breakthrough as Clene Inc. advances its experimental therapy CNM-Au8 toward potential accelerated approval for amyotrophic lateral sclerosis (ALS). The company reported promising clinical results in its first quarter financial update, highlighting potential hope for patients with this devastating neurological condition.

The experimental therapy demonstrated substantial improvements in patient survival, particularly in individuals with more advanced stages of ALS. Clene is preparing to submit a New Drug Application (NDA) to the FDA under the Accelerated Approval pathway in the fourth quarter of 2025, supported by compelling survival data and upcoming biomarker analysis.

Beyond ALS, Clene also presented Phase 2 extension results for multiple sclerosis (MS), showcasing the therapy's potential for neurological repair. The data suggests CNM-Au8 could potentially support remyelination and neuronal restoration, offering a novel approach to treating progressive neurological disorders.

Financially, the company reported a modest net loss of $0.8 million for the first quarter, with $9.8 million in cash reserves expected to fund operations through the third quarter of 2025. This financial stability allows Clene to continue its critical research and development efforts in neurological disease treatment.

CNM-Au8 represents a potentially groundbreaking approach to neurological treatments, targeting mitochondrial function and the NAD pathway while reducing oxidative stress. By focusing on improving central nervous system cell survival and function, the therapy could represent a significant advancement in treating neurodegenerative conditions.

The potential approval of CNM-Au8 could provide new treatment options for patients with ALS, a progressive neurological disease characterized by muscle weakness and eventual paralysis. Current treatment options are limited, making Clene's research particularly promising for patients and healthcare providers.