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Clene Inc. announced on August 10, 2026, that new biomarker analyses will be included in its New Drug Application…
CLNNWClene Inc.
Clene Inc. announced on August 10, 2026, that new biomarker analyses will be included in its New Drug Application (NDA) seeking accelerated approval for CNM-Au8 in amyotrophic lateral sclerosis (ALS). The data indicates that patients whose neurofilament light chain (NfL) levels declined or stabilized experienced significantly longer survival and better functional outcomes compared to controls. Specifically, NfL responders showed a 38% lower risk of death over the full follow-up period, with an average survival gain of nearly six months at four years in the HEALEY trial. These findings address questions raised by the FDA during a March 2026 Type C meeting regarding NfL as a surrogate endpoint. Clene plans to file the NDA early in Q4 2026, supported by these post hoc analyses and a planned Phase 3 confirmatory trial called RESTORE-ALS. Clene Inc. is a late clinical-stage biopharmaceutical company focused on developing therapies for neurodegenerative diseases.