Clene (NASDAQ: CLNN) to Conduct Neurofilament Biomarker Analysis for CNM-Au8(R) in ALS in Early Q4 2025

July 8, 2025 11:04:17
  • The FDA offered supportive feedback on Clene’s proposed statistical analysis plan during a recent Type C meeting.
  • The neurofilament biomarker analysis results could support an accelerated approval submission for CNM-Au8 later in 2025.
  • Clene has two additional FDA meetings scheduled in Q3 2025 to discuss ALS survival data and its MS program.
  • Nearly 200 ALS patients are participating in the NIH-sponsored Expanded Access Program for CNM-Au8.
  • The analysis aims to validate the neuroprotective effects shown in previous HEALEY Platform Trial results.

Clene (NASDAQ: CLNN) and its wholly owned subsidiary, Clene Nanomedicine Inc., a late clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis (“ALS”) and multiple sclerosis (“MS”), is set to move ahead with neurofilament biomarker analyses for its lead candidate CNM-Au8(R) ALS early in the fourth quarter of 2025. The announcement follows a recent productive Type C meeting with the U.S. Food and Drug Administration (“FDA”) (https://ibn.fm/F5AHk).

The planned analyses will examine changes in neurofilament light chain (“NfL”), a recognized biomarker for neurodegeneration, among nearly 200 ALS patients treated through the National Institutes of Health–sponsored Expanded Access Program (“EAP”) for CNM-Au8. The company’s statistical plan will compare…

Read More>>

NOTE TO INVESTORS: The latest news and updates relating to CLNN are available in the company’s newsroom at https://ibn.fm/CLNN

About BioMedWire

BioMedWire (“BMW”) is a specialized communications platform with a focus on the latest developments in the Biotechnology (BioTech), Biomedical Sciences (BioMed) and Life Sciences sectors. It is one of 70+ brands within the Dynamic Brand Portfolio @ IBN that delivers: (1) access to a vast network of wire solutions via InvestorWire to efficiently and effectively reach a myriad of target markets, demographics and diverse industries; (2) article and editorial syndication to 5,000+ outlets; (3) enhanced press release enhancement to ensure maximum impact; (4) social media distribution via IBN to millions of social media followers; and (5) a full array of tailored corporate communications solutions. With broad reach and a seasoned team of contributing journalists and writers, BMW is uniquely positioned to best serve private and public companies that want to reach a wide audience of investors, influencers, consumers, journalists and the general public. By cutting through the overload of information in today’s market, BMW brings its clients unparalleled recognition and brand awareness.

BMW is where breaking news, insightful content and actionable information converge.

To receive SMS alerts from BioMedWire, “Biotech” to 888-902-4192 (U.S. Mobile Phones Only)

For more information, please visit https://www.BioMedWire.com

Please see full terms of use and disclaimers on the BioMedWire website applicable to all content provided by BMW, wherever published or re-published: https://www.BioMedWire.com/Disclaimer

BioMedWire
San Francisco, CA
www.BioMedWire.com
415.949.5050 Office
Editor@BioMedWire.com

BioMedWire is powered by IBN