Clene Inc. has announced that the U.S. Food and Drug Administration (FDA) has granted the company an in-person Type C meeting, scheduled for the first quarter of 2026. The meeting will focus on the review of biomarker and survival data related to Clene’s investigational drug CNM-Au8 for the treatment of amyotrophic lateral sclerosis (ALS). Clene has submitted a pre-meeting briefing package to the FDA that includes previously reported reductions in neurofilament light chain (NfL) and glial fibrillary acidic protein (GFAP), as observed in the HEALEY ALS Platform Trial and an NIH-sponsored Expanded Access Program. New independent analyses indicate that modest reductions in NfL are significantly associated with lower mortality risk in ALS, supporting NfL reduction as a candidate surrogate endpoint for accelerated approval. The company will seek FDA guidance on potential regulatory pathways for CNM-Au8, including the possibility of accelerated approval. Results from the analyses have already been announced, with additional findings to be discussed at the upcoming FDA meeting.
Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Clene Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9623614-en) on January 12, 2026, and is solely responsible for the information contained therein.
Comments