Clene Inc. (NASDAQ: CLNN) to Conduct Neurofilament Biomarker Analysis for CNM-Au8(R) in ALS in Early Q4 2025
The FDA offered supportive feedback on Clene’s proposed statistical analysis plan during a recent Type C meeting. The neurofilament biomarker analysis results could support an accelerated approval submission for CNM-Au8 later in 2025. Clene has two additional FDA meetings scheduled in Q3 2025 to discuss ALS survival data and its MS program. Nearly 200 ALS patients are participating in the NIH-sponsored Expanded Access Program for CNM-Au8. The analysis aims to validate the neuroprotective effects shown in previous HEALEY Platform Trial results. Clene (NASDAQ: CLNN) and its wholly owned subsidiary, Clene Nanomedicine Inc., a late clinical-stage biopharmaceutical company focused on improving…