Clene shares jump 12.33% premarket after announcing significant ALS biomarker results supporting accelerated approval for CNM-Au8.

Clene Inc. surged 12.33% in premarket trading following the announcement of statistically significant biomarker results for CNM-Au8 in ALS, demonstrating reductions in NfL and GFAP linked to improved survival. The FDA-recommended analyses, including NIH-EAP data, reinforced CNM-Au8’s potential disease-modifying activity and supported a planned NDA submission under an accelerated approval pathway. The company requested a Type C meeting with the FDA in Q1 2026 to present the data and highlighted a robust safety profile across over 1,000 patient-years of exposure. These developments, coupled with a scheduled investor webcast, signaled regulatory and commercial progress, boosting investor confidence. The results align with prior constructive FDA interactions and strengthen the case for expedited approval, directly driving the premarket rally.