Clene Inc. (NASDAQ: CLNN) Receives FDA Guidance on Accelerated Approval Pathway for CNM-Au8(R) for ALS
The FDA asked for additional Neurofilament Light (“NfL”) data from the company’s three Expanded Access Protocols to support earlier clinical trial findings. The company has already begun collecting and analyzing this data, with plans to complete the process in Q2 2025 and then submit a New Drug Application (“NDA”) for CNM-Au8 by mid-2025. A follow-up meeting with the FDA will be held early next year to discuss and finalize the statistical analysis plan for the EAP NfL biomarker analyses. The company is meanwhile preparing a confirmatory Phase 3 trial (“RESTORE-ALS”) to evaluate the survival benefit of CNM-Au8 with initial participant…