🚀 NASDAQ: LGVN - FDA Fast Track GRANTED!

ALERT! NASDAQ: LGVN Huge NEWS Just Announced for NASDAQ: LGVN!! U.S. Food and Drug Administration (FDA) Grants Fast Track Designation for Longeveron’s Lomecel-B™ Product for Treatment of Hypoplastic Left Heart Syndrome (HLHS) in Infants New designation may expedite FDA review and potential approval to address this life-threatening heart condition affecting approximately 1,000 babies per year MIAMI, Aug. 31, 2022 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN) ("Longeveron" or "Company"), a clinical stage biotechnology company developing cellular therapies for chronic aging-related and life-threatening conditions, today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to Lomecel-B™ for the treatment of Hypoplastic Left Heart Syndrome (HLHS), a rare and life-threatening congenital heart defect affecting approximately 1,000 infants per year. Lomecel-B™, an investigational allogeneic, bone marrow-derived medicinal signaling cell (MSC) product, is currently in a Phase 2a trial for HLHS. Fast Track Designation is intended to facilitate development and expedite the review of drugs that treat serious conditions and fill an unmet medical need so a product can potentially be approved and reach patients more quickly. Fast Track Designation enables the company to have more frequent interactions with the FDA throughout the drug development process and allows for eligibility for priority review and accelerated approval if certain criteria are met, as well as a rolling review. The Fast Track Designation must continue to be met or FDA can withdraw the designation. The FDA previously granted Longeveron’s Lomecel-B™ Orphan Drug and Rare Pediatric Disease designations in November of 2021 for HLHS. “Fast Track Designation represents a significant milestone in our efforts to develop Lomecel-B™ as a treatment for infants with HLHS,” said Chris Min, M.D., Ph.D., Longeveron’s Interim Chief Executive Officer and Chief Medical Officer. “Fast Track Designation underscores the urgent need in HLHS, and we look forward to continuing to work closely with the FDA to bring this potential new therapy to infants as expeditiously as possible.” HLHS is a rare congenital heart defect that affects approximately 1,000 babies per year in the U.S. Infants born with HLHS have an underdeveloped or absent left ventricle, which impairs the heart’s ability to pump adequate amounts of blood throughout the body. Patients require three reconstructive heart surgeries within the first five years of life, and many require a heart transplant. Without treatment, the condition is always fatal. Even with reconstructive surgical interventions, HLHS is still associated with high mortality. Overall survival from birth to adolescence is estimated to be 50% to 60%. Longeveron is currently evaluating Lomecel-B™ in ELPIS II, an ongoing 38-patient, randomized (1:1), blinded, controlled Phase 2a clinical trial intended to evaluate the safety and efficacy of intramyocardial (directly into the heart) injection of the Lomecel-B™ product in infants with HLHS who are undergoing Stage II reconstructive cardiac surgery. In ELPIS, a Phase 1 open-label trial in ten HLHS patients, Lomecel-B™ was found to be well tolerated with no major adverse cardiac events one-year post-surgery, and/or treatment-related infections. One hundred percent of the infants enrolled in the ELPIS Phase 1 trial (n=10) were alive and had not required a transplant between 2-3.5 years post-surgery. Normally, approximately 20% of patients require heart transplants to survive within one year of Stage II reconstructive surgery. Longeveron recently announced the release of a manuscript entitled [“Intramyocardial cell-based therapy during bidirectional cavopulmonary anastomosis for hypoplastic left heart syndrome: The ELPIS phase I trial”]( on MedRxiv, a preprint server that posts papers before they are peer reviewed. The paper will now undergo peer review prior to publication of the final study report. Link to Full Press: Incase you missed the report from Thursday here it is again: NASDAQ: LGVN In this Golden Age of Biotech, LGVN May Be the Most Promising Story Unfolding Right Now…. Greetings All, The biotech sector continuously presents exciting opportunities…. Many of the best biotech companies have both strong drug candidate pipelines and winning drugs already on the market. It makes sense that their share prices would be pretty high as a result. Emerging biotech players who are scratching the surface with therapies that could benefit multiple markets are ones to keep a super close eye on. Their growth potential could be immense! Longeveron, Inc. (NASDAQ: LGVN) is a rising biotech company that is developing cellular therapies for chronic diseases associated with aging and other life-threatening conditions. Nobody likes to get older... as we age, we become disproportionally affected by chronic conditions and poor health. This is why it’s so exciting to discover a biotech company that is at the start of its story… and is developing anti-aging cures and therapies that may help combat chronic diseases associated with aging. Did you know that there is vast potential for healthy aging to be achieved through regenerative medicine approaches? Regenerative medicine is the BIGGEST medical breakthrough in natural medicine. There are also real opportunities for regenerative medicine in the treatment of COVID-19 and LGVN isn’t ignore this huge space… While the world is busy focused on geopolitical events, cryptocurrencies, and interest rates, paying close attention to breakthroughs in regenerative medicine, treatments of disease, and understanding issues of aging could be incredibly advantageous right now. INTRODUCING: [www.longeveron.com]( Longeveron, Inc. NASDAQ: LGVN Cellular Therapy to Repair Rejuvenate and Restore. Longeveron, Inc. (NASDAQ: LGVN) is a clinical stage biotechnology company developing cellular therapies for specific aging-related and life-threatening conditions. The company believes that healthy aging can be achieved through regenerative medicine approaches. The company’s lead investigational product, Lomecel-B™, is derived from culture-expanded medicinal signaling cells (MSCs) isolated from the donated bone marrow of young healthy adults. LGVN believes that by using the same cells that promote tissue repair, organ maintenance, and immune system function, it can develop safe and effective therapies for some of the most difficult disorders associated with the aging process and other medical disorders. The company is currently sponsoring Phase 1 and 2 clinical trials in the following indications: - Alzheimer’s Disease - Hypoplastic left heart syndrome (HLHS) - Aging Frailty - Acute Respiratory Distress Syndrome (ARDS) These multipotent MSCs have special therapeutic properties, including homing to sites of inflammation and tissue damage, and stimulating tissue repair and organ maintenance, as well as modulation of immune system function. By harnessing these properties from allogeneic cells obtained from young healthy donors, LGVN’s goal is to develop safe and effective cell therapy for some of the most difficult diseases and conditions associated with aging. THE BACKGROUND LGVN was founded on the premise that the very cells within our bodies whose primary function is to repair, restore and regenerate damaged tissue and organs may be developed into a safe and effective “off-the-shelf” cell therapy. This is therapy that could treat chronic aging-related diseases and other life-threatening conditions, to improve health span, and to extend longevity. Therapeutic indications under clinical study include Alzheimer's disease, a condition that affects more than 6.2 million people in the US alone; it’s also the most common form of dementia and is the [sixth leading cause of death in America!]( Continue reading to see why LGVN should be on your radar as the company pioneers a therapy that may help to change the world! As we age, we experience a profound decline, in both number and function, in our own MSCs, a decrease in immune system function, decline in blood vessel functioning, chronic inflammation and other issues. LGVN's clinical data suggest that Lomecel-B™ addresses these conditions through multiple mechanisms of action, or MOAs, that simultaneously target key aging-related processes. The company's therapeutic indications currently under clinical study are: • Hypoplastic Left Heart Syndrome (HLHS) - a congenital birth defect in which the left ventricle (one of the pumping chambers of the heart) is either severely underdeveloped or missing. As a consequence, babies born with this condition have severely diminished systemic blood flow, which requires children to undergo a complex, three stage heart reconstruction surgery process over the course of the first 5 years of their lives. LGVN is testing Lomecel-B as a potential combinatorial therapy candidate to surgical intervention for HLHS. The scientific goal underlying this study builds on surgical advances of the past thirty years, and is intended to address remaining obstacles to improving transplant-free survival in HLHS patients. In fourth quarter 2021, the U.S. FDA granted Rare Pediatric Disease Designation and Orphan Drug Designation to Lomecel-B for the treatment of infants with HLHS! • Alzheimer’s Disease - which affects over 5 million Americans, is a neurodegenerative disorder that leads to progressive memory loss and death. There are few drugs available for treating Alzheimer’s disease, and none that affect the long-term progression of the disease. LGVN has partnered with the Alzheimer’s Association to advance clinical research using a cell therapy approach to treating this devastating disease! • Aging Frailty - Why do some age well while others become frail? Individuals with Aging Frailty are at higher risk for adverse health outcomes such as falls, fractures, loss of independence, susceptibility to infection, institutionalization, hospitalization and death. LGVN is leading the efforts to develop a regenerative medicine approach for intervention and treatment of Aging Frailty! • Metabolic Syndrome - a multifactorial condition characterized by cluster of conditions that increases the risk heart disease, stroke and diabetes. These conditions include obesity around the central area of the body, high blood sugar, dyslipidemia (elevated cholesterol or fats in the blood) and hypertension (high blood pressure). As part of the company's Aging Frailty program, LGVN is exploring the effect of cell therapy on cluster of risk factors associated with the Metabolic Syndrome. AND LAST BUT NOT LEAST… The Company is urgently developing treatment for Influenza and COVID-19 related respiratory distress! Elderly individuals are at high risk for severe complications following infection with influenza or COVID-19. We are testing the use of allogeneic cell therapy to treat acute respiratory distress syndrome. Acute respiratory distress syndrome (ARDS) is a life-threatening lung condition that prevents enough oxygen from getting to the lungs and into the blood. People who develop ARDS often are very ill with another disease or have major injuries. The condition leads to a buildup of fluid in the air sacs which prevents enough oxygen from passing into the bloodstream. Symptoms may include difficulty breathing, low blood pressure and organ failure, rapid breathing and shortness of breath. [ARDS]( occurs in about 150,000 patients per year, can result in both short-term severe consequences (e.g., prolonged and expensive hospitalization, and death), and long-term debilitating consequences (e.g., severe lung fibrosis and pulmonary dysfunction). ARDS due to viral infection is particularly devastating to those with Aging Frailty, and is especially well-appreciated in the context of the COVID-19 pandemic, in which approximately 80% of deaths have occurred in people aged 65 and older. There are currently limited treatment options for ARDS beyond supportive palliative care, making ARDS a “rare disease or condition” under the FDA’s Orphan Drug Act definition, and an extremely important unmet medical need. LGVN’s Novel Therapy Looks to Tackle COVID-19, Flu-Related ARDS! The Phase 1 trial is a multicenter, double-blinded, randomized, placebo-controlled [study to test the safety and efficacy]( of Lomecel-B in adults suffering from ARDS due to either COVID-19 or influenza. Second Quarter Update LGVN’s [second quarter update]( revealed very promising developments! - The company has made steady progress advancing Lomecel-B, through clinical trials for four different indications. - They have enrolled 50% of their planned patient population of 48 in their Phase 2a trial of Lomecel-B in patients with mild Alzheimer’s Disease. - A pre-planned total of 89 patients have been consented to undergo eligibility screening, and the company expects to fully enroll the study on schedule. - On August 8, 2022, the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) accepted an amendment to the company’s Japanese Aging Frailty Trial. LGVN had re-evaluated its Aging Frailty strategy in Japan given the large unmet need there, and the supportive regulatory framework including the pathway recognizing the therapeutic potential of cell therapies through the Act on the Safety of Regenerative Medicine (ASRM). ASRM approval, if granted, could allow the company to provide Lomecel-B in Japan at selected sites, permitting them to enter the market in that country on an accelerated basis. - The company met the primary safety endpoint in the randomized phase of their Phase 1/2 ‘HERA’ Aging Frailty trial. In that study, Lomecel-B does not appear to interfere with the potency of vaccines such as HD Fluzone in the adult population with aging frailty. - In the remainder of 2022 through early 2023, LGVN expects to publish manuscripts for the ELPIS 1 trial and for the previously completed Phase 2b study in Adult Frailty in quality peer-reviewed journals, enroll the first Japanese patient with aging frailty in our Phase 2 study in that country, and complete enrollment of our Phase 2a trial in Alzheimer’s Disease. AND the company has plenty of cash on hand, having $27 million in cash, cash equivalents and short-term investments as of June 30, 2022, expected to be sufficient to fund operations into 2024! Insiders are Buying Stock Usually, when one insider buys stock, it might not be a monumental event. But when multiple insiders are buying like they did in the case of Longeveron Inc. ([NASDAQ:LGVN]( that sends out a positive message to the company's shareholders. Over the last year, the biggest insider purchase was by Director Rock Soffer for US$73k worth of shares, at about [US$3.76 per share.]( An Impressive CEO Leading the Way LGVN’s Board of Directors approved the appointment of current Chief Medical Officer, K. Chris Min, M.D., Ph.D., as [Interim CEO]( back in May. Dr. Min has extensive pharma and biotech clinical development experience, including work developing novel cell therapies, leading research and development (R&D) and clinical teams, and advancing regulatory engagements with the U.S. Food and Drug Administration (FDA) from early clinical stage Investigational New Drug (IND) applications through to pre-approval New Drug Applications (NDA). Prior to joining Longeveron, Dr. Min served as Vice President and Head of Medical & Clinical Development at Enterin Inc. “As Chief Medical Officer Dr. Min has already brought tremendous value to Longeveron. We are confident this will be a smooth transition as we work to identify the next leader for the Company and continue to execute on our mission of delivering living cell therapies to patients with chronic aging-related diseases and other specific life-threatening conditions.” Joshua M. Hare, M.D., Chairman of the Board of Directors and Chief Science Officer. THE BOTTOM LINE The biotech space is so beaten down, several relative valuation metrics suggest it can move up anywhere from 24% to 155%, according to this recent analysis from [Bank of America!]( As prospects for the biotech sector heighten in 2022, Longeveron, Inc. (NASDAQ: LGVN) is a company to keep your eyes on.... the company's therapy could potentially be a game-changer in treating several conditions with major markets! 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