Clene shares surge 38.72% premarket after announcing statistically significant ALS biomarker results supporting accelerated FDA approval for CNM-Au8.

Clene Inc. surged 38.72% in premarket trading following the announcement of statistically significant ALS biomarker results for its investigational therapy CNM-Au8, demonstrating reductions in neurofilament light (NfL) and glial fibrillary acidic protein (GFAP) linked to improved survival. The company reported these findings align with the FDA’s roadmap for accelerated approval and confirmed plans for a Type C meeting in Q1 2026 to discuss a New Drug Application (NDA). Additionally, Clene hosted a December 3, 2025, investor webcast to detail these results and its ALS program update, reinforcing confidence in CNM-Au8’s potential as a disease-modifying treatment. The positive data, coupled with regulatory alignment and upcoming investor engagement, drove the sharp premarket increase.