BioMedNewsBreaks — Clene Inc. (NASDAQ: CLNN) Advances CNM-Au8 in ALS with FDA Guidance on Accelerated Approval Pathway
Clene (NASDAQ: CLNN) received FDA guidance on leveraging data from its ongoing expanded access programs (“EAPs”) to support an accelerated approval application for CNM-Au8, its treatment for ALS. The FDA recommended using neurofilament light chain (“NfL”) biomarker analyses to substantiate the drug’s efficacy. Clene plans to submit additional data in mid-2025, alongside commencing the Phase 3 RESTORE-ALS trial. Clinical findings presented at an FDA meeting highlighted CNM-Au8’s significant survival benefits and benign safety profile, underscoring its potential as a transformative ALS therapy. Clene remains committed to addressing the urgent unmet needs of ALS patients. To view the full press release, visit https://ibn.fm/xFrwd…











