Clene provides regulatory update following FDA Type C meeting

Clene (CLNN) and its subsidiary, Clene Nanomedicine provided a regulatory update following a Type C meeting with the U.S. Food and Drug Administration, FDA, and announced two additional meetings scheduled with the FDA in the 3rd quarter of 2025. In the recently concluded Type C meeting, Clene discussed its proposed statistical analysis plan for comparing neurofilament light biomarker data from its ongoing NIH-sponsored Expanded Access Protocol, supporting nearly 200 people living with ALS treated with compassionate use of CNM-Au8, to matched ALS controls. The FDA provided constructive feedback on Clene’s proposed analysis methodology for assessing NfL change. NfL change will be analyzed following 9 months of treatment and after 6 months of treatment. These analyses are planned to provide supportive data of the NfL change demonstrated in the HEALEY ALS Platform Trial double-blind period following 6 months of treatment with CNM-Au8. The FDA has also confirmed two additional meetings with Clene scheduled for the 3rd quarter of 2025: ALS Survival Data Type C Meeting and End-of-Phase 2 Type B MS Program Meeting