Welcome to our dedicated page for Longeveron news (Ticker: LGVN), a resource for investors and traders seeking the latest updates and insights on Longeveron stock.
Longeveron Inc (LGVN) is a clinical-stage biotechnology pioneer advancing regenerative therapies through mesenchymal stem cell research. This page provides centralized access to official news and press releases for investors tracking the company's progress in treating conditions like hypoplastic left heart syndrome (HLHS), Alzheimer's disease, and aging-related frailty.
Discover timely updates on clinical trial developments, regulatory milestones including FDA designations, and strategic partnerships. Our curated collection offers investors and researchers a reliable resource for understanding Longeveron's investigational product Lomecel-B and its applications in cellular therapeutics.
Key content includes updates on pediatric cardiac care advancements, neurodegenerative disease research breakthroughs, and manufacturing developments for allogeneic therapies. Bookmark this page to stay informed about critical updates affecting Longeveron's position in the regenerative medicine sector.
Longeveron reported Q3 2024 financial results and business updates. The company's Phase 2b ELPIS II trial for Lomecel-B™ in HLHS has reached 80% enrollment, with FDA confirming it as pivotal for BLA submission. Total revenue increased 177% to $1.8M in the first nine months of 2024. Operating expenses decreased 14% year-over-year. The company maintains $22.8M in cash, expected to fund operations through Q4 2025. Notable developments include positive Phase 2a CLEAR MIND trial data in Alzheimer's disease and successful Type C FDA meeting confirming ELPIS II's pivotal status.
Longeveron (NASDAQ: LGVN) has appointed Devin Blass as Chief Technology Officer and Senior Vice President of Chemistry, Manufacturing, and Controls, effective December 2, 2024. Blass brings over 15 years of experience in advanced therapies development and manufacturing. His appointment comes at a important time as the company prepares for a potential Biological License Application submission for HLHS, pending positive results from the ongoing ELPIS II trial. Prior to joining Longeveron, Blass served at the New York Blood Center as SVP of Comprehensive Cell Solutions and held leadership positions at Talaris Therapeutics, Bellicum Pharmaceuticals, and Mesoblast.
Longeveron (NASDAQ: LGVN), a clinical stage regenerative medicine biotechnology company, has scheduled its third quarter 2024 financial results announcement for November 12, 2024, after market close. The company will host a conference call and webcast at 4:30 p.m. ET the same day to discuss results and provide a business update. The conference call will be accessible via phone (1.877.407.0789) with Conference ID 13749428, and a webcast replay will be available on the company's website.
Longeveron presented data on Lomecel-B, their cellular therapy for mild Alzheimer's disease (AD), at the CTAD24 conference. The presentation highlighted that Lomecel-B's ability to inhibit MMP14 correlates with improved clinical outcomes in mild AD patients. Research from the Phase 2a CLEAR MIND trial showed that patients receiving Lomecel-B lots with higher MMP14 inhibitory activity demonstrated enhanced responses versus placebo on various measures, including cognitive function, quality of life, and brain volume. The findings suggest that MMP14 inhibition may protect TIE2 receptor integrity and contribute to the immunomodulatory and pro-vascular effects of Lomecel-B in mild AD treatment.
Longeveron presented long-term survival data for Lomecel-B in Hypoplastic Left Heart Syndrome (HLHS) patients at the CHSS Annual Meeting. The ELPIS I follow-on study showed 100% 5-year survival and no heart transplants needed after Glenn surgery, compared to 83% survival and 5.2% transplant rate in the Single Ventricle Reconstruction Trial. ELPIS I met its primary safety endpoint with 100% survival and transplant-free rate one year post-treatment. The ongoing ELPIS II Phase 2b trial is evaluating Lomecel-B as an adjunct therapy for HLHS versus standard care at twelve institutions.
Longeveron Inc. (NASDAQ: LGVN) announced that its submission on Lomecel-B™ has been selected for a late breaking poster presentation at the 17th Clinical Trials on Alzheimer's Disease Conference (CTAD24) in Madrid, Spain. The presentation, titled 'Lomecel-B inhibition of MMP14 activity predicts Lomecel-B bioactivity in the treatment of mild Alzheimer's disease', will be held on October 29-30, 2024.
CEO Wa'el Hashad expressed excitement about presenting important Lomecel-B™ data at this leading Alzheimer's research forum, stating that the findings offer potential mechanistic and clinical insights for developing cellular-based therapy for Alzheimer's disease. The abstract will also be included in the special CTAD edition of the Journal of Prevention of Alzheimer's Disease (JPAD), the official journal of the CTAD conference.
Longeveron Inc. (NASDAQ: LGVN) announced that its submission titled "Long-term Transplant-free Survival Is Improved In Hypoplastic Left Heart Syndrome With Cell-based Therapy" has been selected for oral presentation at the Congenital Heart Surgeons' Society (CHSS) 51st Annual Meeting. The presentation will showcase 5-year long-term survival data from the ELPIS I follow-on study, focusing on the potential of Lomecel-B™ as an adjunct therapy for treating Hypoplastic Left Heart Syndrome (HLHS).
The presentation is scheduled for Sunday, October 27, 2024, during the Scientific Session II. Longeveron's CEO, Wa'el Hashad, expressed excitement about sharing the data at this leading forum for congenital heart disease clinical investigation. The company is currently conducting the ELPIS II Phase 2b clinical trial, which may serve as the foundation for a BLA submission for potential approval of Lomecel-B™ if the results are positive.
Longeveron Inc. (NASDAQ: LGVN), a clinical stage regenerative medicine biotechnology company, announced its participation in the UBS Virtual Organ Restoration and Cell Therapy Day on October 15, 2024. The company's CEO, Wa'el Hashad, will engage in a Fireside Chat with Ash Verma, SMID-cap Biotech & Specialty Pharma Analyst at UBS Equity Research.
The virtual event is scheduled for Tuesday, October 15, 2024, from 3:00 p.m. to 3:45 p.m. ET. Interested parties can register for the event by contacting their UBS representative. Additionally, Longeveron's investor presentation is available in the 'Events & Presentations' section of the company's website.
Longeveron focuses on developing cellular therapies for life-threatening and chronic aging-related conditions, positioning itself at the forefront of regenerative medicine research.
Longeveron Inc. (NASDAQ: LGVN), a clinical stage regenerative medicine biotechnology company, has announced its participation in the 3rd Annual ROTH Healthcare Opportunities Conference on October 9, 2024 in New York City. The company, which focuses on developing cellular therapies for life-threatening and chronic aging-related conditions, will be represented by Wa'el Hashad, Chief Executive Officer.
Hashad will be speaking on the panel 'Emerging Frontiers in Neuroscience' and will also be available for investor one-on-one meetings. Longeveron has made its investor presentation for the conference accessible in the 'Events & Presentations' section of the company's website, allowing interested parties to review the materials in advance.
Longeveron Inc. (NASDAQ: LGVN) announced its participation in the Alliance for Regenerative Medicine's Cell & Gene Meeting on the Mesa, taking place October 7-9, 2024 in Phoenix, Arizona. The company aims to explore potential partnerships and strategic opportunities for its cellular therapy program in Alzheimer's disease, which has shown positive results in Phase 1 and Phase 2a clinical trials.
Longeveron will also highlight its contract development and manufacturing business at its 15,000 square feet facility with 8 cGMP cleanroom suites. The company's lead investigational therapeutic candidate, Lomecel-B™, has demonstrated promising results in the CLEAR MIND Phase 2a clinical trial for mild Alzheimer's disease. Lomecel-B™ has received both Regenerative Medicine Advanced Therapy (RMAT) designation and Fast Track designation from the FDA for this indication.
