Clene Is Maintained at Buy by D. Boral Capital

The company presented new biomarker data supporting accelerated approval for its ALS therapy, with a New Drug Application planned for the first half of the year and potential commercialization by late 2026 or early 2027. The approach leverages recent regulatory precedents and addresses a significant unmet need in ALS treatment.

Based on Clene Inc. [CLNN] Emerging Growth Conference 88 Audio Transcript — Dec. 10 2025

Clene is advancing its lead ALS therapy, CNM-Au8, toward accelerated FDA approval using biomarker data, with a New Drug Application planned for the first half of the year. If successful, commercialization could occur by late 2026 or early 2027, addressing a major unmet need.

Based on Clene Inc. [CLNN] Emerging Growth Conference 88 Audio Transcript — Dec. 10 2025

Statistically significant reductions in ALS biomarkers NfL and GFAP were observed with CNM-Au8 in both the NIH EAP and HEALEY trials, correlating with improved survival and supporting an accelerated approval pathway. Survival analyses showed substantial risk reductions, and regulatory engagement is ongoing.

Original document: Clene Inc. [CLNN] Slides Release — Dec. 3 2025

Significant reductions in neurofilament and GFAP biomarkers with CNM-Au8 correlated with improved survival in ALS, especially in advanced and bulbar onset patients. The FDA is considering these biomarkers as surrogate endpoints for accelerated approval, and a Phase 3 trial with survival as the primary endpoint is planned.

Based on Clene Inc. [CLNN] Study Update Audio Transcript — Dec. 3 2025

New data from both clinical trials and real-world expanded access show CNM-Au8 significantly reduces key ALS biomarkers (NFL and GFAP) and improves survival, with robust effects in advanced and bulbar onset patients. These findings support an accelerated approval pathway, with a phase 3 trial planned using survival as the primary endpoint.

Based on Clene Inc. [CLNN] Study Update Audio Transcript — Dec. 3 2025