Clene Inc. Advances ALS Treatment Toward Potential FDA Accelerated Approval

Clene Inc. (NASDAQ: CLNN) has made significant progress in its CNM-Au8 program for amyotrophic lateral sclerosis (ALS), revealing promising clinical results that could pave the way for accelerated regulatory approval. The company is preparing to submit a New Drug Application (NDA) to the FDA in the fourth quarter of 2025, supported by compelling survival data and upcoming biomarker analysis.

The most recent data demonstrated that CNM-Au8 significantly improved survival rates in patients with more advanced stages of ALS, a critical finding for a disease with limited treatment options. In addition to ALS research, the company presented Phase 2 extension results for multiple sclerosis (MS), showing potential for remyelination and neuronal repair.

Financially, Clene reported a net loss of $0.8 million for the first quarter, with $9.8 million in cash reserves sufficient to fund operations through the third quarter of 2025. The company's investigational therapy targets mitochondrial function and the NAD pathway while reducing oxidative stress, representing a novel approach to neurological disease treatment.

These developments could represent a significant advancement in neurodegenerative disease management, potentially offering hope for patients with ALS and MS by addressing underlying cellular mechanisms that contribute to disease progression.