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) is a clinical-stage biopharmaceutical leader developing novel nanocrystal therapies for neurodegenerative diseases. This page provides investors and researchers with essential updates on Clene’s progress in treating ALS, multiple sclerosis, and Parkinson’s disease through its innovative Clean-Surface Nanocrystal (CSN) platform.
Find authoritative coverage of Clene’s clinical trials, including updates on lead candidate CNM-Au8®’s impact on mitochondrial health and oxidative stress biomarkers. Track regulatory developments, partnership announcements with research institutions, and analyses of trial data from Phase 2/3 studies. Our curated news collection helps stakeholders monitor Clene’s unique approach to neurodegeneration through nanotechnology.
Key updates include progress toward FDA submissions, Expanded Access Program results, and peer-reviewed research publications. Bookmark this page for real-time access to earnings reports, strategic collaborations, and scientific presentations that demonstrate Clene’s position at the forefront of neurotherapeutic innovation.
Clene presented preliminary data on June 19, 2024, at the International Rett Syndrome Foundation Annual Meeting, showcasing CNM-Au8® as a potential treatment for Rett Syndrome. This rare pediatric neurological disease, primarily affecting females, results in severe developmental impairments. CNM-Au8 demonstrated significant neuroprotective effects and mitochondrial function improvements in in vitro models. Clene aims to extend CNM-Au8’s applications beyond ALS and MS, leveraging its catalytic ability to enhance neuronal survival and remyelination. The study, in collaboration with Dr. Kathrin Meyer and researchers, highlights CNM-Au8's promise in treating multiple nervous system disorders.
Clene presented extended survival data and new neurofilament light (NfL) responder results for CNM-Au8 30 mg treatment from the HEALEY ALS Platform Trial open label extension at the 2024 ENCALS meeting.
The data showed a significant improvement in survival rates, with a hazard ratio of 0.431 (p=0.0002), demonstrating a 60% decreased risk of death up to 3.5 years post-baseline compared to matched PRO-ACT controls.
The trial included 59 participants originally randomized to CNM-Au8 30 mg treatment and 11 ex-placebo participants. Additionally, NfL responder analysis indicated an average 28% reduction in NfL levels (p<0.0001), suggesting decreased axonal loss. CNM-Au8 was found to be safe and well-tolerated with no identified safety signals over 650 patient years of exposure.
These results support CNM-Au8 as a potential treatment for ALS.
Clene (Nasdaq: CLNN), a clinical-stage biopharmaceutical company specializing in mitochondrial health and neuronal protection for neurodegenerative diseases, announced its participation in the Emerging Growth Conference.
The virtual presentation will take place on June 12, 2024, at 2:20 p.m. EDT and includes a corporate presentation with a Q&A session. The webcast will be accessible on Clene's website and a replay will be available on the Emerging Growth YouTube Channel.
The Emerging Growth Conference offers public companies a platform to present their innovations to a broad investor audience, including individual and institutional investors, as well as investment advisors and analysts.
Clene has announced updates for its NIH-funded Expanded Access Program (ACT-EAP) for CNM-Au8 in ALS. The first patient visit is planned for early June 2024. Enrollment has increased by 80%, now accommodating up to 180 participants. The program aims to collect 'real-world' data on drug efficacy, safety, survival, and disease progression. The initiative, supported by a four-year NIH grant, is designed in collaboration with Columbia University and Synapticure. The expanded access aims to improve the understanding of ALS and provide more treatment options for patients.
Clene (Nasdaq: CLNN) and its subsidiary Clene Nanomedicine, a late clinical-stage biopharmaceutical company, will be participating in three major investor conferences in May 2024.
The conferences include the Mizuho Neuroscience Summit on May 20-21, the Benchmark 2024 Healthcare House Call Virtual Conference on May 21-22, and the Virtual A.G.P. Healthcare Conference on May 22.
Clene focuses on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases like ALS, Parkinson's disease, and multiple sclerosis. Its investigational therapy, CNM-Au8®, aims to enhance central nervous system cell survival by targeting mitochondrial function and reducing oxidative stress.
Clene Inc. (Nasdaq: CLNN) reported its first quarter 2024 financial results and operating highlights, showcasing significant data from the Phase 2 VISIONARY-MS clinical trial of CNM-Au8® demonstrating repair and remyelination. The company also received a $7.3 million NIH grant for the ALS Expanded Access Program and had $27.9 million in cash and marketable securities as of March 31, 2024. Clene continues to advance its FDA discussions in ALS and aims to file a New Drug Application in 2024.
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