Clene Inc. Advances Promising ALS Treatment Toward Potential FDA Accelerated Approval

Biotechnology company Clene Inc. has reported substantial progress in its neurodegenerative disease research, specifically for amyotrophic lateral sclerosis (ALS), with its investigational therapy CNM-Au8 showing promising survival data and potential for accelerated regulatory approval.

The company is preparing to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration under the Accelerated Approval pathway in the fourth quarter of 2025. Recent data highlights the therapy's significant impact on patient survival, particularly for individuals with more advanced stages of ALS.

In addition to ALS research, Clene presented Phase 2 extension results for multiple sclerosis (MS), demonstrating potential for remyelination and neuronal repair. The investigational CNM-Au8 therapy targets mitochondrial function and the NAD pathway while reducing oxidative stress, representing a novel approach to treating neurodegenerative conditions.

Financially, the company reported a first-quarter net loss of $0.8 million, balanced by reduced expenses and $9.8 million in cash reserves, which are expected to fund operations through the third quarter of 2025. This financial position supports continued research and development efforts toward potential regulatory submission.

The research represents a critical advancement in neurodegenerative disease treatment, offering hope for patients with limited therapeutic options. By focusing on improving central nervous system cell survival and function, Clene's approach could potentially transform management strategies for ALS and MS.