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. develops regenerative cellular therapies centered on laromestrocel, also known as Lomecel-B, a proprietary allogeneic investigational cell therapy. The company’s clinical programs address hypoplastic left heart syndrome, Alzheimer’s disease, pediatric dilated cardiomyopathy, and aging-related frailty.
Recurring news for LGVN covers clinical-trial safety reviews, FDA interactions and designations, intellectual-property updates for mesenchymal stem cell methods, financial results, private placements, and Nasdaq-related corporate matters. Updates often focus on the ELPIS II HLHS program, laromestrocel regulatory strategy, and financing used to support clinical development.
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™.
Longeveron (NASDAQ: LGVN) has appointed three new members to its Board of Directors: Douglas Losordo, M.D., Erin Borger, and Cathy Ross. Dr. Losordo brings over 20 years of biotech experience, previously serving in key roles at KBP Biosciences and Caladrius Biosciences. Erin Borger, a managing director at UBS Financial Services, has extensive experience in wealth management and medical board service. Cathy Ross boasts over 30 years in finance, including leadership roles at Fraud.Net and MotherNature.com. These appointments coincide with Longeveron's recent IPO, as it advances its mission in cellular therapies for aging-related diseases.
Longeveron Inc. (NASDAQ:LGVN) announced the pricing of its initial public offering (IPO) of 2,660,000 shares at $10.00 each, aiming for $26.6 million in gross proceeds before expenses. The IPO will close on February 17, 2021, with a 30-day option for underwriters to purchase an additional 399,000 shares. Trading on the Nasdaq starts February 12, 2021. The company's lead product, LOMECEL-B™, targets aging-related conditions. The SEC approved the registration statement on February 11, 2021.