8-K filing — Clene Inc. (CLNN)
Filed: 2026-11-04 AccNo: 0001437749-26-034775 Size: 348 KB Item 2.02: Results of Operations and Financial Condition Item 9.01: Financial Statements and Exhibits
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Clene Inc. Reports Third Quarter 2026 Financial Results and Provides CNM-Au8 Program Updates
Clene Inc. announced its financial results for the third quarter of 2026 and provided progress updates on its lead clinical candidate, CNM-Au8.
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Clene Announces New Drug Application Submission to FDA for CNM-Au8 for the Treatment of ALS
Clene Inc. (Nasdaq: CLNN) announced the submission of a New Drug Application (NDA) to the FDA in October 2026 seeking accelerated approval of CNM-Au8 for treating amyotrophic lateral sclerosis (ALS). The submission is based on neurofilament light chain biomarker data and clinical outcomes. The company plans to continue with a confirmatory Phase 3 RESTORE-ALS study while awaiting FDA review.
Clene Submits New Drug Application To FDA For Accelerated Approvla Of CNM-Au8
NDA submission seeks accelerated approval of CNM-Au8 based on neurofilament light chain biomarker data and clinical outcomes
Clene shares are trading higher after the company announced the pricing of a registered direct offering of 1,219,513 shares at $3.28 per share to existing shareholders with total gross proceeds of $4 million.