Clene publishes 2025 annual report, targets FDA accelerated approval path for ALS drug CNM-Au8

Reuters04:39

Clene publishes 2025 annual report, targets FDA accelerated approval path for ALS drug CNM-Au8

Clene annual report for fiscal 2025 highlighted CNM-Au8 as lead asset, positioning program toward FDA accelerated approval pathway for ALS based on survival signals and plasma neurofilament light (NfL) reductions.
Company targeted NDA submission by end of June 2026, with Type C in-person FDA meeting scheduled in Q1 2026 and minutes expected early Q2 2026.
Clene planned to start RESTORE-ALS Phase 3 confirmatory trial in second half of 2026, with initiation also described as planned by year-end 2026, contingent on funding.
Manufacturing scale-up and commercial planning were flagged as near-term priorities to support potential ALS launch.
Pipeline strategy extended beyond ALS, with Phase 3 planning in multiple sclerosis focused on cognition following FDA feedback, supported by earlier target-engagement work in Parkinson’s disease.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Clene Inc. published the original content used to generate this news brief on April 10, 2026, and is solely responsible for the information contained therein.

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