NetworkNewsBreaks – Clene Inc. (NASDAQ: CLNN) Co
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Posted On: 03/07/2025 3:22:42 PM
NetworkNewsBreaks – Clene Inc. (NASDAQ: CLNN) Collaborates to Support Potential Accelerated Pathway for ALS Treatment Candidate
Clene (NASDAQ: CLNN) and its wholly owned subsidiary, Clene Nanomedicine Inc., is partnering with APST Research GmbH to analyze neurofilament light chain (“NfL”) data in evaluating its drug candidate, CNM-Au8®, for ALS treatment. Based in Germany, APST operates one of the largest ALS biomarker repositories, which includes data from over 4,300 ALS patients. This collaboration will enable Clene to compare NfL levels in patients treated with CNM-Au8 against historical ALS controls to assess the drug’s potential in slowing disease progression. The goal is to use these findings to support FDA accelerated approval for CNM-Au8 by demonstrating its ability to reduce NfL decline and improve survival rates. Clene is planning to submit a new drug application (“NDA”) to the FDA in the second half of 2025 for potential accelerated approval. The NDA will contain data on NfL changes and survival with CNM-Au8 treatment, bolstered by results of this study. CNM-Au8, an oral suspension of gold nanocrystals, is designed to target mitochondrial dysfunction and promote neuronal health.
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) and its wholly owned subsidiary, Clene Nanomedicine Inc., is partnering with APST Research GmbH to analyze neurofilament light chain (“NfL”) data in evaluating its drug candidate, CNM-Au8®, for ALS treatment. Based in Germany, APST operates one of the largest ALS biomarker repositories, which includes data from over 4,300 ALS patients. This collaboration will enable Clene to compare NfL levels in patients treated with CNM-Au8 against historical ALS controls to assess the drug’s potential in slowing disease progression. The goal is to use these findings to support FDA accelerated approval for CNM-Au8 by demonstrating its ability to reduce NfL decline and improve survival rates. Clene is planning to submit a new drug application (“NDA”) to the FDA in the second half of 2025 for potential accelerated approval. The NDA will contain data on NfL changes and survival with CNM-Au8 treatment, bolstered by results of this study. CNM-Au8, an oral suspension of gold nanocrystals, is designed to target mitochondrial dysfunction and promote neuronal health.
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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