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About Clene Inc. (Nasdaq: CLNN)
Clene Inc. is a late clinical-stage biopharmaceutical company dedicated to revolutionizing treatment options for neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS), multiple sclerosis (MS), and Parkinson’s disease. Headquartered in Salt Lake City, Utah, with research and development facilities in Maryland, Clene is at the forefront of leveraging nanotechnology to address critical unmet medical needs. The company’s patented Clean-Surface Nanocrystal (CSN) Technology enables the production of high-purity nanocrystals that enhance cellular energy metabolism and reduce oxidative stress, key contributors to neurodegeneration.
Core Technology and Innovation
Clene’s proprietary CSN platform represents a paradigm shift in pharmaceutical development, moving beyond traditional small-molecule drugs and biologics. By utilizing high-purity metallic nanocrystals, the technology targets mitochondrial function, the NAD pathway, and oxidative stress, enhancing the survival and functionality of central nervous system cells. This approach is exemplified by Clene’s lead candidate, CNM-Au8®, an oral suspension of gold nanocrystals designed to restore neuronal health and function.
Focus on Neurodegenerative Diseases
Clene is primarily focused on addressing neurodegenerative diseases with limited treatment options. Its flagship product, CNM-Au8®, is being developed for ALS, MS, and Parkinson’s disease. By improving mitochondrial health and reducing biomarkers like neurofilament light (NfL), CNM-Au8® has demonstrated potential in delaying disease progression and improving survival rates in clinical trials. Clene is also exploring the application of CNM-Au8® in rare diseases such as Rett Syndrome, further expanding its therapeutic scope.
Clinical Pipeline and Regulatory Progress
Clene’s clinical pipeline includes multiple Phase 2 and Phase 3 trials for CNM-Au8®. The company has garnered support from the National Institutes of Health (NIH) and other organizations to advance its research. Notably, Clene’s Expanded Access Programs (EAPs) provide real-world evidence of CNM-Au8®’s efficacy, particularly in ALS. These programs, combined with biomarker analyses and survival data, are integral to Clene’s pursuit of an accelerated approval pathway with the U.S. Food and Drug Administration (FDA).
Strategic Partnerships and Market Position
Clene collaborates with leading institutions, including Columbia University and Massachusetts General Hospital, to advance its clinical programs. The company recently partnered with APST Research GmbH to leverage one of the largest ALS biomarker datasets for regulatory submissions. By focusing on mitochondrial health and oxidative stress, Clene differentiates itself from competitors in the neurodegenerative disease space, such as Biogen and Amylyx Pharmaceuticals.
Commitment to Patients and Future Outlook
Clene’s mission is deeply rooted in improving patient outcomes. With over 800 participant-years of safety data and a robust clinical pipeline, the company is well-positioned to address the urgent needs of patients with neurodegenerative diseases. As Clene progresses toward regulatory milestones, its innovative approach to nanomedicine holds promise for transforming the treatment landscape.
Clene Inc. (NASDAQ: CLNN) announced the validation of key patents from the European Patent Office that protect its innovative processes for treating neurodegenerative diseases. The patents enhance the company's lead candidate, CNM-Au8, a gold nanocrystal suspension aimed at treating amyotrophic lateral sclerosis (ALS). This significant development supports a Phase 3 registration study expected to reveal topline results in H2 2022. The patents offer extensive coverage for Clene's manufacturing methods and treatment approaches, bolstering its position in major global healthcare markets.
Clene Nanomedicine, a clinical-stage biopharmaceutical company, has received a $1 million grant from the Maryland Department of Housing and Community Development to support redeveloping its manufacturing facility in Elkton, MD. This expansion aims to boost manufacturing capacity for the anticipated commercialization of its lead drug candidate, CNM-Au8, targeting amyotrophic lateral sclerosis (ALS). Clene expresses gratitude for the state's support and emphasizes its commitment to community infrastructure growth.
Clene Inc. (NASDAQ: CLNN) presented significant findings from its RESCUE-ALS Phase 2 trial of CNM-Au8 at the 32nd International Symposium on ALS/MND on December 10, 2021. The trial demonstrated that CNM-Au8 significantly slowed disease progression and improved quality of life in early ALS patients. Notable results included a reduced risk of major functional decline and no serious adverse effects observed. While the primary endpoint regarding motor unit index changes was not met, the therapy showed potential as a breakthrough treatment for ALS.
Clene Inc. (NASDAQ: CLNN) presented key findings from its Phase 2 RESCUE-ALS trial of CNM-Au8 at the 32nd International Symposium on ALS/MND. The trial indicated that CNM-Au8 significantly slowed disease progression in early-stage ALS patients, demonstrating reduced risk of decline in the ALSFRS-R score and improved quality of life. Notably, the treatment was well-tolerated with no serious adverse events. While the primary endpoint was not met, the results suggest potential neuroprotective effects and long-term survival benefits for patients with limb onset ALS.
Clene Inc. (NASDAQ: CLNN) has reported promising results from the RESCUE-ALS Phase 2 study of its drug candidate CNM-Au8® for amyotrophic lateral sclerosis (ALS). Data presented at the ALS ONE Research Symposium indicates that CNM-Au8 has a favorable impact on ALS progression, meeting FDA-recommended endpoints. Key findings include consistent efficacy in both limb and bulbar onset patients, with an average Combined Assessment of Function and Survival (CAFS) score improvement of +4.4 compared to a decline of -4.6 in the placebo group. Long-term survival data suggests potential benefits compared to estimated median survival rates.
Clene Inc. (NASDAQ: CLNN) announced the completion of enrollment in the HEALEY ALS Platform Trial for its leading drug candidate, CNM-Au8®, a gold nanocrystal suspension. This innovative trial is the first of its kind for ALS and aims to facilitate the development of new therapies. Topline data is expected in the second half of 2022, with plans to file a New Drug Application if CNM-Au8 meets its primary endpoint. The trial includes over 50 sites across the U.S., aiming to accelerate research and provide new hope for ALS patients.
Clene Inc. (Nasdaq: CLNN) recently shared its Q3 2021 results and updates on clinical trials. The RESCUE-ALS Phase 2 trial for CNM-Au8 indicated potential benefits for ALS patients, though it did not meet its primary endpoint. Positive exploratory data revealed clinically relevant improvements. The company also launched an FDA Expanded Access Program for ALS patients. Cash and restricted cash stood at $60.6 million. Notably, Clene reported a net income of approximately $28.9 million, influenced by an unrealized gain from contingent liabilities, contrasting with a net loss in Q3 2020.
Clene Inc. (Nasdaq: CLNN) has announced results from the RESCUE-ALS Phase 2 trial, evaluating its drug candidate CNM-Au8 for early amyotrophic lateral sclerosis (ALS). The trial did not meet its primary endpoint (MUNIX) or secondary endpoint (FVC) at week 36, although a trend indicating efficacy was observed at week 12 (p=0.057). Notably, significant improvements were noted in disease progression and quality of life measures. The trial demonstrated potential protective effects on lower motor neurons in limb onset ALS patients, comprising 70% of the ALS population. Results from the Healey ALS Platform Trial are anticipated in late 2022.
Clene Inc. (NASDAQ: CLNN) has launched a second FDA expanded access program (CNMAu8.EAP02) for its investigational therapy CNM-Au8 to assist ALS patients unable to enroll in the Healey ALS Platform Trial. This initiative aims to provide critical access to CNM-Au8, which is being investigated for treating amyotrophic lateral sclerosis, while the primary trial's results are expected in mid-2022. The program is supported by key trial sites and is part of Clene's ongoing commitment to address the needs of ALS communities.
Clene Inc. (NASDAQ: CLNN) announced significant results from its Phase 2 REPAIR-PD clinical trial for CNM-Au8, a gold nanocrystal suspension aimed at treating Parkinson's disease. The trial demonstrated a statistically significant increase in the brain NAD+/NADH ratio, a crucial marker for energy metabolism, with a p-value of 0.037. This improvement corresponds to reversing about 20 decades of normal aging. There were no serious adverse events, further reinforcing CNM-Au8's safety profile. The company presented these findings at the International Parkinson and Movement Disorder Society Virtual Congress.
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