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Posted On: 07/25/2025 3:57:53 PM
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NetworkNewsBreaks – Clene Inc. (NASDAQ: CLNN) Builds Momentum to Bring New Hope to Neuro Patients
Clene (NASDAQ: CLNN), together with its subsidiary Clene Nanomedicine Inc., is preparing to initiate neurofilament biomarker analyses for its lead drug candidate CNM-Au8(R) in ALS, following feedback from the FDA during a recent Type C meeting. Slated for early Q4 2025, the analyses will assess changes in neurofilament light chain (“NfL”)—a recognized marker for neurodegeneration—among nearly 200 patients treated through the Expanded Access Program for CNM-Au8.
“We are encouraged by the FDA’s collaborative approach and their constructive feedback on our NfL biomarker analysis plan from the ongoing NIH-sponsored EAP program,” said Benjamin Greenberg, MD, Head of Medical at Clene. “With two additional FDA meetings scheduled to discuss long-term ALS survival results and the End-of-Phase 2 MS results, we are advancing our ALS and MS programs to deliver an innovative therapy for people living with neurodegenerative diseases.”
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), together with its subsidiary Clene Nanomedicine Inc., is preparing to initiate neurofilament biomarker analyses for its lead drug candidate CNM-Au8(R) in ALS, following feedback from the FDA during a recent Type C meeting. Slated for early Q4 2025, the analyses will assess changes in neurofilament light chain (“NfL”)—a recognized marker for neurodegeneration—among nearly 200 patients treated through the Expanded Access Program for CNM-Au8.
“We are encouraged by the FDA’s collaborative approach and their constructive feedback on our NfL biomarker analysis plan from the ongoing NIH-sponsored EAP program,” said Benjamin Greenberg, MD, Head of Medical at Clene. “With two additional FDA meetings scheduled to discuss long-term ALS survival results and the End-of-Phase 2 MS results, we are advancing our ALS and MS programs to deliver an innovative therapy for people living with neurodegenerative diseases.”
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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