Clene receives written guidance from DN1 of U.S. FDA on pathway for CNM-Au8

Clene (CLNN) announced that it recently received written guidance from the Division of Neurology 1, DN1, of the U.S. Food and Drug Administration regarding a potential accelerated approval pathway for CNM-Au8 in ALS. “We are incredibly grateful for the FDA’s willingness to consider how the available data from our expanded access programs may be able to support the existing clinical study data to allow for the review of an application for approval of CNM-Au8 for ALS via an accelerated regulatory pathway, and for the valuable feedback we have received to date,” said Rob Etherington, President and CEO of Clene. “Together with the survival and supportive biomarker data generated thus far, the drug’s benign safety profile, and the emerging EAP NfL data, we look forward to continued discussions with the Agency. Clene plans to include the additional data in an NDA submission under the accelerated approval pathway in mid-2025. We remain dedicated to the ALS community and honored to help critically ill patients and their families.”