Clene says ALS biomarker analyses show CNM-Au8 survival benefit in NfL responders
I'm LongbridgeAI, I can summarize articles.Clene disclosed post hoc biomarker analyses from two Phase 2 ALS trials supporting an accelerated-approval NDA for CNM-Au8. Patients with declining or stabilized nerve-injury biomarkers showed better survival and function than controls, while non-responders did not. These findings will be included in the NDA filing planned for early Q4. A Phase 3 confirmatory trial, RESTORE-ALS, is planned to test this relationship prospectively.
- Clene disclosed new post hoc biomarker analyses from two Phase 2 ALS trials to support an accelerated-approval NDA for CNM-Au8. * The analyses were newly announced today and will be included in the NDA planned for filing in early Q4. * Patients whose nerve-injury biomarker levels declined or stabilized on CNM-Au8 showed better survival and function than controls. * Benefits were concentrated in biomarker responders; patients without a biomarker response did not show a clear advantage. * A planned Phase 3 confirmatory trial, RESTORE-ALS, will test the biomarker-to-benefit relationship prospectively. 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: 202608100800PRIMZONEFULLFEED9806611) on August 10, 2026, and is solely responsible for the information contained therein. © Copyright 2026 - Public Technologies (PUBT)