Clene Inc.
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- Clene Inc. (NYSE American: CLNN) develops and commercializes nanotechnology-based therapeutics for the treatment of neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS) and Parkinson's disease. The company offers CNM-Au8, a novel oral suspension of clean-surfaced, catalytically-active gold nanocrystals designed to restore neuronal energy metabolism and support neuroprotection; it is currently in late-stage clinical development for ALS and multiple system atrophy, with investigational new drug status for Parkinson's disease. Clene also provides diagnostic tools and related services through its nanotechnology platform, targeting patients with orphan neurological disorders. Founded in 2019 and headquartered in Salt Lake City, Utah, Clene operates primarily in the United States and Europe, with clinical trials conducted across North America and select international sites. The company serves healthcare providers, patients, and biopharmaceutical partners in the rare disease and neurology sectors, leveraging its proprietary CURATE platform for nanostructured material production. In 2024, Clene completed a strategic restructuring under Chapter 11 bankruptcy protection, emerging in October with a reorganized capital structure supported by new equity investments from Palladio Biosciences and other investors; this included $15 million in fresh funding to advance CNM-Au8 toward regulatory submission. The company announced positive final results from its RESCUE-ALS open-label extension trial in mid-2025, demonstrating sustained survival benefits and functional improvements in ALS patients, paving the way for a planned New Drug Application filing with the FDA by year-end. Additionally, Clene expanded its manufacturing capabilities through a partnership with a contract development and manufacturing organization in 2025 to support commercial-scale production of CNM-Au8.
Company News
Clene Announces New Drug Application Submission to FDA for CNM-Au8 for the Treatment of ALS
Reviewing Addex Therapeutics (NASDAQ:ADXN) & Clene (NASDAQ:CLNN)
Clene Targets Q4 FDA Filing for ALS Drug CNM-Au8, Eyes Mid-2027 Decision
Clene Inc. (NASDAQ:CLNN) Receives Average Recommendation of “Moderate Buy” from Brokerages
Clene to Present at Upcoming Investor Conferences
Clene Announces Closing of $4 Million Registered Direct Offering Extending Capital Runway Beyond FDA Decision on CNM-Au8® NDA
Clene Announces $4 Million Registered Direct Offering
Canopy Growth (NASDAQ:CGC) vs. Clene (NASDAQ:CLNN) Financial Comparison
Clene to Present at Upcoming September Investor Conferences
Clene Eyes Q4 NDA for ALS Drug After FDA-Requested Biomarker Analyses
Presenting on Emerging Growth Conference 95 Day 2 on August 20; Register to live stream
Clene to Present at the Emerging Growth Conference
Clene Inc. (CLNN) Reports Q2 Loss, Beats Revenue Estimates
Clene Reports Second Quarter 2026 Financial Results and Recent Operating Highlights
Clene Targets Early Q4 NDA Filing for CNM-Au8 in ALS
Clene to Present at The Canaccord 46th Annual Growth Conference
Clene (CLNN) May Find a Bottom Soon, Here's Why You Should Buy the Stock Now
Clene Inc. (CLNN) Reports Q1 Loss, Misses Revenue Estimates
Clene Reports First Quarter 2026 Financial Results and Recent Operating Highlights
Clene Announces $7 Million Underwritten Offering of Common Stock