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

July 19, 2024 10:16:42
  • 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…

Read More>>

NOTE TO INVESTORS: IBN is a multifaceted financial news, content creation and publishing company utilized by both public and private companies to optimize investor awareness and recognition. For more information, please visit https://www.InvestorBrandNetwork.com

Please see full terms of use and disclaimers on the InvestorBrandNetwork website applicable to all content provided by IBN, wherever published or re-published: http://IBN.fm/Disclaimer

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

Corporate Communications

IBN (InvestorBrandNetwork)
Los Angeles, California
www.InvestorBrandNetwork.com
310.299.1717 Office
[email protected]