Clene Inc. Advances Neurodegenerative Disease Treatment with FDA-Backed Biomarker Analysis

July 25th, 2025 2:15 PM
By: Newsworthy Staff

Clene Inc. is set to conduct neurofilament biomarker analyses for its drug CNM-Au8 in ALS patients, following FDA feedback, marking a significant step towards innovative neurodegenerative disease therapies.

Clene Inc. Advances Neurodegenerative Disease Treatment with FDA-Backed Biomarker Analysis

Clene Inc. (NASDAQ: CLNN) and its subsidiary Clene Nanomedicine Inc. are moving forward with neurofilament biomarker analyses for their lead drug candidate, CNM-Au8(R), in ALS patients, after receiving constructive feedback from the FDA. The analyses, planned for early Q4 2025, will focus on neurofilament light chain (NfL), a key indicator of neurodegeneration, in nearly 200 patients from the Expanded Access Program. Benjamin Greenberg, MD, Head of Medical at Clene, expressed optimism about the FDA's collaborative stance and the upcoming discussions on ALS survival and MS treatment outcomes. This initiative underscores Clene's commitment to developing groundbreaking treatments for neurodegenerative diseases. For more details, visit https://ibn.fm/t3Lli.

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