BioMedNewsBreaks – Clene Inc. (NASDAQ: CLNN) Advances Regulatory Strategy for CNM-Au8 with FDA Meetings Scheduled for ALS and MS Programs

Clene (NASDAQ: CLNN) announced key regulatory developments following a Type C meeting with the FDA, where it received feedback on its statistical analysis plan (SAP) for evaluating neurofilament light (NfL) biomarker data from its Expanded Access Protocol for ALS. The company has resubmitted a revised SAP and anticipates FDA acceptance this summer, with NfL analyses scheduled for early Q4 2025 to support a potential NDA submission under the accelerated approval pathway. Clene also confirmed two additional FDA meetings in Q3 2025: one to assess long-term ALS survival data for accelerated approval consideration and another End-of-Phase 2 Type B meeting to review Phase 2 MS trial results and discuss a Phase 3 study targeting cognitive improvement.

To view the full press release, visit https://ibn.fm/iLzgr

About Clene Inc.

Clene (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine Inc., is a late clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis, Parkinson’s disease and multiple sclerosis. CNM-Au8® is an investigational first-in-class therapy that improves central nervous system cells’ survival and function via a mechanism that targets mitochondrial function and the NAD pathway while reducing oxidative stress. CNM-Au8® is a federally registered trademark of Clene Nanomedicine, Inc. The company is based in Salt Lake City, Utah, with R&D and manufacturing operations in Maryland. For more information, please visit www.Clene.com.

NOTE TO INVESTORS: The latest news and updates relating to CLNN are available in the company’s newsroom at https://ibn.fm/CLNN

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