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Clene Receives FDA Guidance for Accelerated Approval Pathway for CNM-Au8 in ALS

Clene (NASDAQ: CLNN) and its subsidiary, Clene Nanomedicine Inc., received FDA guidance for potential accelerated approval of their lead drug candidate CNM-Au8 in ALS. The guidance followed a Type C meeting where Clene presented additional clinical trial data and analyses. Clene plans to submit an NDA under the accelerated approval pathway in mid-2025.

This news matters as it provides insight into the potential accelerated approval of a drug candidate for ALS, a debilitating neurodegenerative disease. The FDA guidance indicates progress in the development of a therapy that could significantly impact ALS patients and their families.