Welcome to our dedicated page for Clene news (Ticker: CLNN), a resource for investors and traders seeking the latest updates and insights on Clene stock.
Clene Inc. (Nasdaq: CLNN) generates a steady stream of news as a late clinical-stage biopharmaceutical company focused on neurodegenerative and neurological diseases. Company updates frequently center on its lead investigational therapy CNM-Au8, an oral suspension of gold nanocrystals designed to improve mitochondrial function, brain energy metabolism, and neuronal resilience in conditions such as amyotrophic lateral sclerosis (ALS), multiple sclerosis (MS), and Parkinson’s disease (PD).
Investors and followers of CLNN news can expect detailed announcements on clinical trial results, biomarker analyses, and regulatory interactions. In ALS, Clene has reported statistically significant reductions in biomarkers like neurofilament light chain (NfL) and glial fibrillary acidic protein (GFAP) with CNM-Au8 treatment, along with analyses linking biomarker changes to survival outcomes. News releases also cover FDA-recommended analyses, Type C meeting requests and outcomes, and the company’s plans for a potential New Drug Application under the accelerated approval pathway.
For MS and PD, Clene’s news includes Phase 2 data from REPAIR-MS and REPAIR-PD, where CNM-Au8 improved the brain NAD+/NADH ratio and related measures of energy metabolism, as well as preclinical PD data on mitochondrial health and cellular function. The company also issues regular financial and corporate updates, including quarterly results, equity distribution activity, convertible note agreements, and registered direct offerings that support its development and regulatory programs.
This CLNN news page aggregates these disclosures, from scientific conference presentations and investor webcasts to financing announcements and SEC-related communications. Readers who track Clene’s progress can use this feed to follow the evolution of CNM-Au8 across ALS, MS, and PD, monitor key regulatory milestones, and understand how new biomarker and survival data shape the company’s development strategy.
Clene Inc. (NASDAQ: CLNN) announced positive interim data from its studies, VISIONARY-MS and REPAIR-MS, presented at the ACTRIMS Forum 2021. Interim results demonstrate CNM-Au8's potential in improving neurological functions in multiple sclerosis (MS) patients. The VISIONARY-MS trial showed significant enhancements in MS Functional Composite (MSFC) scores compared to baseline (p0.0001). The REPAIR-MS study indicated notable metabolic improvements in CNS markers, suggesting a homeostatic effect of CNM-Au8. Unblinded topline data for both studies are expected in 2022.
Clene Inc. (NASDAQ: CLNN) will present updated interim data from its REPAIR-MS and VISIONARY-MS studies at the ACTRIMS Forum 2021, from February 25-27. The REPAIR-MS study examines the safety and efficacy of CNM-Au8 in patients diagnosed with MS, while the VISIONARY-MS trial focuses on its effects on chronic visual impairment in stable relapsing MS patients. Key endpoints of VISIONARY-MS include improvements in low contrast letter acuity and other functional tests after treatment. The results may highlight CNM-Au8’s potential in treating neurodegenerative diseases.
Clene Inc. (NASDAQ: CLNN) announced that its subsidiary Clene Nanomedicine received ANVISA approval to conduct a Phase 2 clinical study in Brazil. The trial will assess the efficacy and safety of CNM-ZnAg in treating acutely symptomatic, non-hospitalized COVID-19 patients. It aims to enroll approximately 276 patients, focusing on reducing hospitalizations at 28 days. While vaccines are available, the need for COVID-19 therapeutics persists. Results are expected in the second half of 2021, showcasing the company's dedication to advancing therapeutic solutions.
Clene Inc. (NASDAQ: CLNN) announced that its subsidiary received a Notice of Allowance from the USPTO for a patent regarding the use of its gold nanocrystals, CNM-Au8, in treating Multiple Sclerosis (MS). This patent expands Clene's intellectual property, which now includes over 130 issued and pending patents. CNM-Au8 is being tested in Phase 2 and 3 trials for MS and Amyotrophic lateral sclerosis (ALS), targeting an estimated $23 billion treatment market. Interim results from ongoing studies show potential improvements in CNS bioenergetic metabolites.
Clene Inc. (NASDAQ: CLNN) completed its merger with Tottenham Acquisition I Limited, effective December 31, 2020, providing approximately $31.9 million in funding, including $22.4 million from PIPE financing. Clene's clinical pipeline includes ongoing Phase 3 and multiple Phase 2 studies targeting neurodegenerative diseases such as ALS, MS, and Parkinson’s disease. The company aims to leverage its nanocatalysis technology for innovative treatments. Interim data from recent trials indicate promising outcomes, positioning Clene for potential growth in this high-need medical area.