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. (NASDAQ: LGVN) is a clinical stage biotechnology company developing cellular therapies for life-threatening, rare pediatric and chronic aging-related conditions. Its news flow centers on the progress of its lead investigational product, laromestrocel (Lomecel-B), an allogeneic mesenchymal stem cell therapy derived from the bone marrow of young, healthy adult donors.
On this page, readers can follow LGVN news related to key clinical programs in hypoplastic left heart syndrome (HLHS), mild Alzheimer’s disease, pediatric dilated cardiomyopathy (DCM), and aging-related frailty. Company announcements highlight milestones such as pivotal Phase 2b trial enrollment in HLHS (ELPIS II), Phase 2a data in Alzheimer’s disease from the CLEAR MIND study, and regulatory interactions including FDA designations like Orphan Drug, Fast Track, Rare Pediatric Disease, and Regenerative Medicine Advanced Therapy (RMAT).
Longeveron’s news also covers intellectual property developments, including U.S. and Canadian patents for the use of its proprietary mesenchymal stem cells in aging-related frailty, non-ischemic dilated cardiomyopathy, and female sexual dysfunction. Scientific and medical conference activity, such as poster presentations at the Clinical Trials on Alzheimer’s Disease (CTAD) conference and participation in cardiovascular clinical trial forums, provides additional insight into how the company positions laromestrocel within neurodegenerative and cardiovascular research.
Investors and observers can use this LGVN news feed to track clinical trial updates, patent grants, financing transactions disclosed in press releases, and other corporate developments that Longeveron reports through GlobeNewswire and SEC-related communications.
Longeveron Inc. (NASDAQ: LGVN) reported its financial results for Q4 and full year 2020, highlighting a net loss of $1.4 million for Q4 compared to $0.5 million in Q4 2019. Revenue was $1.2 million in Q4 2020, down from $1.8 million in Q4 2019, primarily due to decreased grant revenue. However, revenue from the Bahamas Registry Trial increased by 119% year-over-year. The company secured a $29.1 million IPO and anticipates sufficient cash to support operations through Q4 2022. Upcoming results from multiple clinical trials are expected in 2021.
Longeveron (NASDAQ: LGVN), a clinical stage biotechnology company, announced a conference call on March 30, 2021, at 8:30 a.m. ET to discuss its fiscal 2020 financial results and provide a business update. The call will be accessible via telephone and a webcast. Longeveron is focused on developing cellular therapies for chronic aging-related and life-threatening conditions, with its lead product, LOMECEL-B™, targeting multiple indications including Aging Frailty and Alzheimer’s disease. An audio replay of the call will be available until April 6, 2021.
MIAMI, March 19, 2021 – Longeveron (NASDAQ: LGVN), a biotechnology company focused on cellular therapies for aging-related and life-threatening conditions, will present at the Q1 Virtual Investor Summit. The event runs from March 23-25, 2021, with Longeveron's presentation scheduled for March 24 at 10:00 am ET. This summit connects smallcap companies with investors, featuring over 100 companies and 300 investors. Longeveron is advancing its lead therapy, LOMECEL-B, aimed at conditions like Aging Frailty and Alzheimer’s disease. For more details, visit longeveron.com.
Longeveron Inc. (NASDAQ:LGVN) announced the partial exercise of its over-allotment option by underwriters in its IPO, increasing total shares sold to 2,910,000 at a public offering price of $10.00. This results in gross proceeds of $29.1 million before offering expenses. The SEC had previously declared effective a registration statement for these securities on February 11, 2021. Longeveron is focused on developing cell-based therapies for aging-related conditions and is sponsoring clinical trials for several serious health issues.
Longeveron Inc. (NASDAQ: LGVN) received FDA approval for expanded access to its investigational cell therapy, Lomecel-B, for a child with Hypoplastic Left Heart Syndrome (HLHS). The therapy aims to enhance the right ventricle's function, which is crucial for HLHS patients. Dr. Sunjay Kaushal of Ann & Robert H. Lurie Children’s Hospital will administer the treatment during surgery. Lomecel-B is derived from bone marrow and produced in Miami. The company successfully completed a Phase 1 study demonstrating safety, leading to a Phase 2 trial set for Q3 2021, progressing towards regulatory approval.
Longeveron Inc. (NASDAQ: LGVN) has amended its exclusive license agreement and formed a Collaborative Research and Development Agreement with the University of Miami. This agreement enhances access to clinical data and intellectual property related to Lomecel-B technology. Key elements include two IND applications for aging frailty and hypoplastic left heart syndrome, a patent application for treating endothelial dysfunction, and modifications to milestone payments. The partnership aims to advance Longeveron's cellular therapies aimed at chronic aging-related conditions.
Longeveron Inc. (NASDAQ: LGVN) announced an expansion of enrollment criteria for its Phase 1 RECOVER trial targeting Acute Respiratory Distress Syndrome (ARDS). The trial now includes mild ARDS patients, in addition to those with moderate and severe cases. This double-blind, placebo-controlled study will assess the safety and efficacy of Lomecel-B, a bone marrow-derived therapy, in COVID-19 or Influenza-infected ARDS patients. The study aims to mitigate severe inflammation and improve clinical outcomes. The RECOVER trial is partially funded by a TEDCO award and is set to grow its participating clinical sites.
Longeveron Inc. (NASDAQ: LGVN) has completed its Phase 2b clinical study of Lomecel-B for Aging Frailty, supported by a National Institute on Aging SBIR Grant. The study involved 149 subjects randomized to receive either Lomecel-B or a placebo, focusing on exercise tolerance and various health metrics. Top-line data is anticipated in Q3 2021. Aging Frailty affects approximately 8.1 million Americans over 65, leading to severe health complications. Lomecel-B aims to address inflammation related to this condition, and Longeveron is engaged in multiple clinical trials across various regions.
Longeveron Inc. (NASDAQ: LGVN) has completed its Phase 1 clinical trial of Lomecel-B for Hypoplastic Left Heart Syndrome (HLHS), demonstrating good tolerability with no serious adverse cardiac events reported. The trial involved 10 children undergoing the Glenn procedure. With promising safety results, the company plans to initiate a Phase 2 trial in Q3 2021, funded by a $5.6M grant from the NIH, which will assess Lomecel-B’s efficacy in 32 patients nationwide. Full Phase 1 results are expected in Q2 2021.
Longeveron Inc. (NASDAQ: LGVN) announced that CEO Geoff Green will present on "A Regenerative Medicine Approach to Aging Frailty" at the Intercontinental Summit on Aging & Gerontology on March 8, 2021. The virtual summit, hosted by the Sciinov Group, aims to unite researchers and scientists to discuss advancements in Aging & Gerontology. Longeveron is focused on developing cellular therapies for aging-related conditions, including Alzheimer’s disease and Aging Frailty, through its investigational product LOMECEL-B™.
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