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) has submitted new CNM-Au8 biomarker and clinical efficacy data to the FDA for ALS treatment. Key findings include:
1. CNM-Au8 NfL Responders showed significant improvements in survival, functional status, and combined function and survival.
2. Long-term CNM-Au8 treatment demonstrated substantial survival benefits compared to matched controls.
3. NAD and glutathione improvements were consistent with CNM-Au8 treatment, supporting its dual mechanism of action.
4. Safety profile remains strong with no significant concerns identified over 650 patient years of data.
These results aim to support discussions with the FDA for an accelerated approval pathway for CNM-Au8 in ALS treatment.
Clene Inc. (Nasdaq: CLNN), a clinical-stage biopharmaceutical company focusing on neurodegenerative diseases, has announced its participation in the Canaccord Genuity 44th Annual Growth Conference & Private Company Showcase. The event is scheduled for August 13, 2024, with Clene's presentation set for 11:30 am EST.
Clene specializes in improving mitochondrial health and protecting neuronal function to treat conditions such as amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS). The company's management will deliver a presentation and host one-on-one investor meetings during the conference.
Interested parties can access a webcast of the presentation through Clene's website in the 'Events' section or via a provided registration link.
Clene (Nasdaq: CLNN), a clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, such as ALS and MS, will present at the Emerging Growth Conference. The virtual presentation is scheduled for July 18, 2024, at 4:45 p.m. EDT and will include a corporate update and Q&A session. The webcast will be available on Clene's website and the Emerging Growth YouTube Channel. The Emerging Growth Conference is designed to connect public companies with investors, featuring companies from various growth sectors. Clene's investigational therapy, CNM-Au8®, targets mitochondrial function to improve cell survival and reduce oxidative stress. Based in Salt Lake City, Clene also has R&D and manufacturing operations in Maryland.
Clene announced plans to submit a briefing book to the FDA by July 13, 2024, ahead of a Type C interaction scheduled for Q3 2024. The aim is to gain feedback on the accelerated approval pathway for CNM-Au8®, intended to treat ALS. The briefing book includes post-hoc analyses from completed clinical studies, focusing on neurofilament light (NfL) biomarker reduction, matured survival data, and evidence of CNM-Au8’s mechanism of action. These analyses address prior FDA comments and aim to demonstrate CNM-Au8’s potential for accelerated approval. Further data insights will be shared publicly later in 2024, and Clene will announce the FDA's feedback after the Type C interaction.
Clene (Nasdaq: CLNN), a biopharmaceutical company developing treatments for neurodegenerative diseases like ALS and MS, announced a 1-for-20 reverse stock split effective July 11, 2024. The split aims to comply with Nasdaq's $1.00 minimum closing bid price requirement. Clene's common stock will trade under the new CUSIP number 185634201, but the trading symbol 'CLNN' remains unchanged. Authorized by stockholders in May 2024, the reverse split reduces the total outstanding shares from approximately 128.7 million to 6.4 million, while maintaining each stockholder's ownership percentage. Equiniti Trust Company will manage the exchange and provide details to stockholders. Additional information is available in Clene's SEC filings and on their website.
Clene, a clinical-stage biopharmaceutical company, will present at H.C. Wainwright’s 5th Annual Neuro Perspectives Virtual Conference. The event, scheduled for June 27, 2024, will feature a fireside chat format and 1x1 investor meetings. Clene focuses on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases such as amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS). The webcast of the presentation will be available on Clene's website.
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.