Clene shares surge 11.71% after hours on FDA meeting and NDA plan for ALS therapy.

Clene Inc. (CLNN) surged 11.71% in after-hours trading following the release of its third-quarter 2025 results and regulatory updates. The stock’s rise was driven by progress in its ALS program, including FDA alignment on biomarker analyses to support an accelerated New Drug Application (NDA) filing in Q1 2026 and plans to initiate the confirmatory Phase 3 RESTORE-ALS trial in H1 2026. The FDA’s endorsement of three biomarker pathways to strengthen data credibility, coupled with cash runway extension into Q2 2026 after raising $1.2 million, reduced near-term execution risks. These developments signaled regulatory clarity and operational resilience, fueling investor optimism about the potential for accelerated approval of CNM-Au8 for ALS, a critical milestone for the biopharmaceutical company.