Clene Inc. (NASDAQ: CLNN) reported promising developments in its neurodegenerative disease research, particularly for amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), during its first quarter 2025 financial results.
The biopharmaceutical company is preparing to submit a New Drug Application (NDA) under the FDA’s Accelerated Approval pathway for ALS in the fourth quarter of 2025. This submission will be supported by survival data and upcoming biomarker analysis that show significant potential for the company’s investigational therapy, CNM-Au8.
Recent research revealed that CNM-Au8 significantly improved survival rates among patients with more severe ALS, marking a critical advancement in treatment options for this challenging neurological condition. Additionally, the company presented Phase 2 extension results for multiple sclerosis, demonstrating potential for remyelination and neuronal repair.
Financially, Clene reported a net loss of $0.8 million for the quarter, accompanied by a cash balance of $9.8 million, which is expected to fund operations through the third quarter of 2025. The reduced expenses suggest strategic management of resources while maintaining critical research momentum.
CNM-Au8 represents a novel therapeutic approach targeting mitochondrial health and neuronal function. The investigational therapy aims to improve central nervous system cell survival by addressing mitochondrial function, the NAD pathway, and reducing oxidative stress.
The potential FDA Accelerated Approval pathway could provide a faster route to making this promising treatment available to patients with ALS, a progressive neurodegenerative disease with limited current treatment options. The company’s focus on improving mitochondrial health and neuronal function offers hope for patients facing challenging neurological conditions.
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