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Clene (NASDAQ: CLNN) Receives FDA Guidance on Accelerated Approval Application for CNM-Au8 ALS Treatment

Clene (NASDAQ: CLNN) receives 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.

This news matters as it highlights significant progress in the development of a potential treatment for ALS, a devastating neurodegenerative disease. The FDA guidance and ongoing clinical trials offer hope for ALS patients and their families, signaling a potential breakthrough in addressing the urgent unmet needs of those affected by the disease.