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8-K: Current report

SEC ·  Jul 11 21:03
Summary by Futu AI
On July 11, 2024, Clene Inc. announced its intention to submit a briefing book to the U.S. Food and Drug Administration (FDA) for a Type C interaction regarding the accelerated approval pathway for its drug CNM-Au8®, aimed at treating amyotrophic lateral sclerosis (ALS). The submission, planned for July 13, follows previous FDA feedback and includes new post-hoc analyses from completed clinical studies. Clene's briefing book aims to demonstrate CNM-Au8®'s potential based on neurofilament light (NfL) biomarker reduction as a surrogate endpoint, along with survival and functional benefit data. The company anticipates a meeting with the FDA in the third quarter of 2024 to discuss the new drug application (NDA) submission for accelerated approval. Clene plans to publicly share the FDA's topline feedback after the Type C interaction. Clene Inc., along with its subsidiary Clene Nanomedicine Inc., is a clinical-stage biopharmaceutical company focusing on neurodegenerative diseases and is based in Salt Lake City, Utah.
On July 11, 2024, Clene Inc. announced its intention to submit a briefing book to the U.S. Food and Drug Administration (FDA) for a Type C interaction regarding the accelerated approval pathway for its drug CNM-Au8®, aimed at treating amyotrophic lateral sclerosis (ALS). The submission, planned for July 13, follows previous FDA feedback and includes new post-hoc analyses from completed clinical studies. Clene's briefing book aims to demonstrate CNM-Au8®'s potential based on neurofilament light (NfL) biomarker reduction as a surrogate endpoint, along with survival and functional benefit data. The company anticipates a meeting with the FDA in the third quarter of 2024 to discuss the new drug application (NDA) submission for accelerated approval. Clene plans to publicly share the FDA's topline feedback after the Type C interaction. Clene Inc., along with its subsidiary Clene Nanomedicine Inc., is a clinical-stage biopharmaceutical company focusing on neurodegenerative diseases and is based in Salt Lake City, Utah.
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