Clene Inc. Advances Regulatory Strategy for CNM-Au8 with FDA Meetings Scheduled for ALS and MS Programs

Clene Inc. (NASDAQ: CLNN) has announced significant regulatory advancements for its investigational therapy CNM-Au8, following a productive Type C meeting with the FDA. The company received valuable feedback on its statistical analysis plan (SAP) for evaluating neurofilament light (NfL) biomarker data from its Expanded Access Protocol for ALS. With a revised SAP submitted and FDA acceptance anticipated this summer, Clene is on track to conduct NfL analyses by early Q4 2025, supporting a potential New Drug Application (NDA) submission under the accelerated approval pathway.

Further bolstering its regulatory strategy, Clene has scheduled two additional FDA meetings in Q3 2025. The first meeting will assess long-term ALS survival data for accelerated approval consideration, while the second, an End-of-Phase 2 Type B meeting, will review Phase 2 MS trial results and discuss the design of a Phase 3 study aimed at cognitive improvement. These developments underscore Clene's commitment to advancing CNM-Au8 as a potential treatment for neurodegenerative diseases, including ALS and MS, by targeting mitochondrial health and neuronal function.

For more details on Clene's regulatory progress and upcoming FDA meetings, visit https://ibn.fm/iLzgr.