Clene shares rise 11.92% intraday as CEO outlines Q1 2026 NDA plans for CNM-Au8 and regulatory progress.

Clene (CLNN) surged 11.92% intraday following a $1.2 million fundraising extension and regulatory progress in its CNM-Au8 pipeline. Despite Q3 2025 earnings reporting an 82.8% revenue decline and a $8.78 million net loss, the company announced FDA-endorsed biomarker pathways for its ALS candidate and plans to file a New Drug Application (NDA) in Q1 2026. Preclinical Parkinson’s data showing mitochondrial improvements and ongoing discussions on cognition-focused endpoints for MS trials further bolstered investor optimism. The fundraising extended liquidity to mid-2026, addressing prior concerns over cash sustainability, while regulatory alignment signaled potential accelerated timelines for key trials. These developments outweighed the earnings disappointment, driving the intraday rebound.