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Clene plans to submit a briefing book to the U.S. Food and Drug Administration by July 13 as Part of Overall Process to Support Approval for CNM-Au8(R) for Treatment of ALS
Type C interaction is aimed at obtaining FDA feedback on the potential pathway for a new drug application for CNM-Au8 as a treatment for ALS via the accelerated approval process
The briefing book includes new post-hoc analyses of data from completed clinical trials and addresses comments made by the FDA during a previous meeting in late 2023

Clene (NASDAQ: CLNN) and its wholly owned subsidiary Clene Nanomedicine Inc., a clinical-stage biopharmaceutical company dedicated to enhancing mitochondrial health and protecting neuronal function to combat neurodegenerative diseases such as amyotrophic lateral sclerosis (“ALS”) and multiple sclerosis (“MS”), have revealed plans to submit a briefing book to the U.S. Food and Drug Administration (“FDA”) by July 13. This submission precedes a granted Type C interaction scheduled for the third quarter of 2024, aimed at obtaining FDA feedback on the potential pathway for a new drug application (“NDA”) for CNM-Au8 as a treatment for ALS via the accelerated approval process (https://ibn.fm/icmDr).

CNM-Au8, Clene’s primary therapeutic asset, is a highly concentrated aqueous suspension of catalytically active, clean-surfaced, faceted gold nanocrystals. Neurodegenerative diseases often involve multiple pathogenic factors leading to neuronal death, with mitochondrial dysfunction and NAD+ decline being…

Clene (NASDAQ: CLNN) Announces Plan to Submit Briefing Book to FDA Preceding Type C Interaction