Clene to submit accelerated approval NDA for ALS drug CNM-Au8 in Q3 2026 after positive FDA feedback

Clene Inc. announced it will submit a New Drug Application (NDA) for its ALS treatment CNM-Au8 to the FDA in the third quarter of 2026 under the accelerated approval pathway. The FDA indicated that biomarker data on neurofilament light (NfL) may support this submission, recognizing NfL as a potential surrogate endpoint predicting clinical benefits. This marks a significant step for CNM-Au8, a first-in-class therapy addressing a critical unmet need in ALS treatment. Clene is also preparing to start a Phase 3 confirmatory trial in early 2027, continuing its efforts to bring this therapy to patients urgently needing new options.