Clene Inc. Advances Regulatory Strategy for CNM-Au8 with FDA Meetings Scheduled for ALS and MS Programs
Clene Inc. progresses in its regulatory strategy for CNM-Au8, with FDA meetings set to discuss ALS and MS treatments, marking a significant step towards potential accelerated approval.
Clene Inc. (NASDAQ: CLNN) has made significant strides in its regulatory strategy for CNM-Au8, following a Type C meeting with the FDA. The company received feedback on its statistical analysis plan for evaluating neurofilament light biomarker data from its Expanded Access Protocol for ALS. A revised SAP has been resubmitted, with FDA acceptance anticipated this summer. NfL analyses are scheduled for early Q4 2025, supporting a potential NDA submission under the accelerated approval pathway.
Additionally, Clene has confirmed two FDA meetings in Q3 2025. One will assess long-term ALS survival data for accelerated approval consideration, and the other, an End-of-Phase 2 Type B meeting, will review Phase 2 MS trial results and discuss a Phase 3 study aimed at cognitive improvement. These developments underscore Clene's commitment to advancing treatments for neurodegenerative diseases.
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