BioMedNewsBreaks — Clene Inc. (NASDAQ: CLNN) Prepares to Submit Briefing Book to FDA, Looks to Obtain Key Feedback Regarding NDA for CNM-Au8 in ALS
Clene (NASDAQ: CLNN) and its wholly owned subsidiary, Clene Nanomedicine Inc., a clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis (“ALS”) and multiple sclerosis (“MS”), is in the process of submitting a briefing book to the U.S. Food and Drug Administration (“FDA”). The company anticipates submitting the book by July 13, 2024, in advance of the FDA granting a Type C interaction. According to the announcement, the purpose of the interaction between Clene and the FDA is to obtain key feedback on the potential path to submission of…