BioMedNewsBreaks — Clene Inc. (NASDAQ: CLNN) Looking to Advance Discussions for Accelerated Approval, New NDA for CNM-Au8(R) in 2024
Clene (NASDAQ: CLNN), alongside its wholly owned subsidiary Clene Nanomedicine Inc., is a clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases. These include amyotrophic lateral sclerosis (“ALS”) and multiple sclerosis (“MS”). “Clene’s lead candidate, CNM-Au8(R), is a gold nanocrystal suspension that has emerged as a promising candidate for the treatment of both ALS and MS… Despite the FDA’s decision in late 2023 against allowing Clene to move forward with an accelerated approval pathway based on initial biomarker data, Clene is diligently preparing supplemental data to provide additional supportive biomarker, survival and mechanistic…