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Posted On: 12/10/2024 4:13:44 PM
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NetworkNewsBreaks – 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.
NOTE TO INVESTORS: The latest news and updates relating to CLNN are available in the company’s newsroom at https://nnw.fm/CLNN
Please see full terms of use and disclaimers on the NetworkNewsWire website applicable to all content provided by NNW, wherever published or republished: http://NNW.fm/Disclaimer
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.
NOTE TO INVESTORS: The latest news and updates relating to CLNN are available in the company’s newsroom at https://nnw.fm/CLNN
Please see full terms of use and disclaimers on the NetworkNewsWire website applicable to all content provided by NNW, wherever published or republished: http://NNW.fm/Disclaimer
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