Clene shares surge 10.11% after hours as ALS biomarker results support accelerated approval pathway.

Clene Inc. (Nasdaq: CLNN) surged 10.11% in after-hours trading following the announcement of statistically significant biomarker results for its ALS candidate CNM-Au8, supporting an accelerated approval pathway. The company reported reductions in neurofilament light (NfL) and glial fibrillary acidic protein (GFAP) in trial participants, biomarkers strongly linked to improved survival. These findings, aligned with FDA recommendations, reinforce CNM-Au8’s potential as a disease-modifying therapy. Clene also requested a Type C meeting with the FDA in Q1 2026 to discuss an NDA submission under the accelerated approval pathway and hosted an investor webcast to detail the data. The results extend prior positive interactions with regulators and highlight CNM-Au8’s safety profile with no serious adverse events reported. The news directly correlates with the stock’s upward movement, reflecting optimism about regulatory progress and therapeutic potential.