Clene Receives FDA Guidance for Accelerated Approval Pathway for CNM-Au8 in ALS
December 27, 2024 — 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.