Clene submits NDA to FDA for ALS drug CNM-Au8

Clene Inc. (Nasdaq: CLNN) announced on October 19, 2026 that it had submitted a New Drug Application to the U.S. Food and Drug Administration earlier in October seeking accelerated approval of CNM-Au8 for the treatment of amyotrophic lateral sclerosis. The NDA submission seeks accelerated approval of CNM-Au8 based on neurofilament light chain biomarker data and clinical outcomes.¹

Rob Etherington, Clene's President and Chief Executive Officer, said in the release that the NDA submission represents an important achievement for Clene, CNM-Au8, and especially for people living with ALS.¹ He added that the company appreciates the FDA's constructive engagement throughout the process and looks forward to working closely with the agency during its review.¹

Etherington also said the company remains focused on advancing CNM-Au8 through the regulatory process while continuing preparations for the confirmatory Phase 3 RESTORE-ALS study.¹

According to the release, Clene Inc., along with its subsidiaries including its wholly owned subsidiary Clene Nanomedicine, Inc., describes itself as a late clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis, Parkinson's disease, and multiple sclerosis.¹ The company describes CNM-Au8 as an investigational first-in-class therapy that works by targeting mitochondrial function and the NAD pathway in central nervous system cells, while also reducing oxidative stress, to support cell survival and function.¹

The filing states that Clene is based in Salt Lake City, Utah, with research, development, and manufacturing operations in Maryland.¹ The announcement was filed as an exhibit to a Form 8-K dated October 19, 2026, signed by Robert Etherington as President and Chief Executive Officer.