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  • Longeveron (LGVN) Experiences Stock Boost Following Regulatory Green Light

    Longeveron (LGVN) Experiences Stock Boost Following Regulatory Green Light

    After securing pivotal regulatory approval, Longeveron Inc. (NASDAQ: LGVN) stock is witnessing a substantial uptick in the current market session. As of the latest assessment, LGVN shares have surged by 53.11% on the US stock charts, reaching $4.39.

    Lomecel-B Receives RMAT Designation from the FDA

    A news statement from Longeveron (LGVN) states that the Regenerative Medicine Advanced Therapy or RMAT designation has been given to Lomecel-B by the U.S. Food and Drug Administration (FDA) for the treatment of moderate Alzheimer’s disease. Publicly accessible data indicates that Lomecel-B is the first candidate for cellular treatment to get the RMAT designation for Alzheimer’s disease.

    The Lomecel-B effort and Longeveron have accomplished a great deal with the RMAT designation, which underscores the encouraging possibility of cellular treatment to benefit patients with this crippling illness. Like the classification for breakthrough therapy, the RMAT designation has a number of advantages.

    These consist of comprehensive FDA guidelines for effective medication development, chances for early FDA interactions to talk about surrogate or intermediate endpoints, and possible ways to satisfy post-approval criteria and speed up approval. Moreover, a priority review of the biologics license application (BLA) may follow the approval of the Priority Review designation, which occurs after the BLA submission.

    Encouraging Clinical Trial Results

    Alzheimer’s Disease, a neurodegenerative disorder that causes progressive memory loss and death, currently has very limited treatment options. In the CLEAR MIND Phase 2a clinical trial, Lomecel-B exhibited a notable slowing or prevention of disease progression compared to placebo. The trial successfully met its primary safety and secondary efficacy endpoints and demonstrated statistically significant improvements in pre-specified clinical and biomarker endpoints in specific Lomecel-B groups compared to the placebo.

    Future Prospects and Continued Validation

    For Lomecel-B, Longeveron has already gained four specific regulatory recognitions, including the RMAT classification. The Lomecel-B HLHS program has previously been granted three distinct FDA designations: Orphan Drug designation, Fast Track designation, and Rare Pediatric Disease designation.

    Acquiring the RMAT designation will enable Longeveron to further validate its previous work and facilitate crucial dialogues with the FDA. This progress enhances the potential to advance Lomecel-B as a viable therapeutic option for the numerous patients afflicted with Alzheimer’s Disease.

  • Market Responds Positively To Latest Longeveron (LGVN) Efforts

    Market Responds Positively To Latest Longeveron (LGVN) Efforts

    As of the last check during current-market session, the stock value of Longeveron Inc. (NASDAQ: LGVN) increased significantly on US charts, gaining by 49.17% to $2.70. The company’s participation in a noteworthy event is responsible for this spike, which has a favorable effect on investor confidence.

    CEO’s Address During the Emerging Growth Conference

    On June 12, 2024, Mohamed Wa’el Hashad, the CEO and director of Longeveron (LGVN), gave the keynote speech at the 72nd Emerging Growth Conference. EmergingGrowth.com, a reputable independent small-cap media company, is hosting the conference. It has been highlighting companies with strong management teams, innovative products and services, and an intense focus on long-term growth across a range of growing industries.

    Progress In ELPIS II Clinical Trial

    In addition to the market activity, Longeveron successfully conducted an investigator meeting for ELPIS II, its ongoing Phase 2b clinical trial. This trial is evaluating Lomecel-B as a potential adjunct treatment for Hypoplastic Left Heart Syndrome (HLHS), a rare congenital heart defect in children.

    The meeting, which gathered principal investigators and site staff from leading pediatric treatment institutions, focused on the trial’s progress and operational strategies. Three nationally recognized pediatric cardiothoracic centers also participated as part of their preparation to join as investigative sites.

    The initial data from ELPIS I demonstrated that infants treated with Lomecel-B had a 100% transplant-free survival rate up to five years of age, compared to a historical control data mortality rate of approximately 20%. ELPIS II aims to further assess the safety and efficacy of Lomecel-B in this patient population, with full enrollment expected by the end of 2024.

    Collaboration And Future Prospects

    Lomecel-B, the company’s primary experimental treatment, is an adult human bone marrow-derived medicinal signaling cell therapy that is scalable, proprietary, and allogeneic. With funding from the National Institutes of Health (NIH), the ELPIS II experiment is being carried out in partnership with the National Heart, Lung, and Blood Institute (NHLBI) with the goal of enrolling 38 pediatric patients by the end of 2024. Building on the encouraging outcomes of ELPIS I, this trial highlights Lomecel-B’s potential as a regenerative medical treatment for newborns with HLHS.

  • Longeveron Inc. (LGVN) Takes on Seemingly Spontaneous Afterhours Price Jump

    Longeveron Inc. (NASDAQ: LGVN) embarked on an impressive journey during Friday’s trading session, showcasing an impressive uptick of 8.4%, propelling its value from $2.03 to $2.20. However, the real spectacle unfolded post-market closure, as LGVN underwent a staggering surge of 48% in after-hours trading, sending shockwaves through the investment community.

    This remarkable ascent was accompanied by a significant spike in trading volume, with a whopping 2.5 million shares changing hands, a stark contrast to the average daily volume of 40,000 shares, highlighting the fervent interest surrounding the stock.

    Analyzing the Surge: Absence of News and Investor Sentiment

    The surge in LGVN’s price is particularly intriguing given the absence of any discernible catalysts. While some investors celebrate the bullish momentum, there are whispers of caution regarding potential profit-taking dips in the days to come.

    Nonetheless, amidst the uncertainty, the bullish sentiment prevails, driving many to capitalize on the current momentum.

    Company Overview and Strategic Maneuvers

    Longeveron stands at the forefront of biotechnological innovation, with a focus on developing regenerative medicines to address pressing medical needs. Its flagship product, Lomecel-B™, derived from the bone marrow of healthy adult donors, exhibits promising potential across various medical domains, including Hypoplastic Left Heart Syndrome, Alzheimer’s disease, and Aging-related Frailty.

    Despite recent developments, Longeveron garnered attention following a pivotal announcement regarding a reverse stock split.

    Reverse Stock Split: Implications and Objectives

    In a strategic move aimed at bolstering per-share trading prices and ensuring compliance with Nasdaq listing requirements, Longeveron’s Board of Directors sanctioned a 1-for-10 reverse split of its common stock.

    Effective March 26, 2024, this tactical maneuver seeks to instill confidence among investors while reaffirming the company’s commitment to sustainable growth.

    Reflections and Prospects

    Despite enduring a gradual decline over the past year, with its stock plummeting from $44 to $2, Longeveron remains steadfast in its pursuit of excellence.

    Moreover, the substantial ownership stake held by insiders, amounting to 64% of the company, underscores a shared dedication to shareholder interests.

  • Longeveron Inc. (LGVN)’s Alzhimer’s Study-Related Rally Culminate in Corrections

    Aging brings multiple woes to the human body, including those ailments and disorders which impact the quality of life immensely. Some are even life-threatening. A company working on therapies for such conditions is Longeveron Inc. (LGVN).

    The clinical-stage biotech company garnered tremendous interest from investors on March 31, 2022. Thus, the stock was trending at a wild 4,431% of its average volume of shares on Thursday. The stock took off and flew sky high during intraday trading to report a surge of over 105.36%. This uptick in the stock comes from the company’s publication of Alzheimer’s study data in the Alzheimer’s & Dementia® journal.

    Inevitably such a huge rise in the stock was followed by a downtrend in the after-hours session. LGVN stock fell prey to corrections in the after-hours as it shed 9.28% in the later session.

    Source: AcademiaMag

    LGVN’s Movement Analysis

    While the stock’s latest upsurge culminated in corrections, LGVN has a picture full of green. The drug makers ha been largely bullish with the stock making some nice gains throughout 2021. The bullish momentum has so far continued into the current year as well with year-to-date gains of 14.33%. The prior year’s gains stand at a monumental 112.63%.

    Given the success of its Alzheimer’s treatment candidate thus far, the company is on track for a bright future holding possible commercialization of the drug in the coming years.

    Alzheimer’s Study & Latest Publication

    The company’s Alzheimer’s disease (AD) study has been famous among the investors who have placed their bets on the company each time any related announcement was made. As per the latest news, the trial has been a success so far with the primary endpoint being achieved in the Phase 1 testing. Depicting good tolerability, the under-study drug candidate, Lomecel-B has shown promising results in mild AD patients. Hence, the data warrants further exploration of the drug’s therapeutic potential in AD.

    The promising data from the trial were published in Alzheimer’s & Dementia®: The Journal of Alzheimer’s Association.

    LGVN’s Financial Overview

    As per the latest financials, the company’s performance was not so impressive in the ending quarter of 2021. LGVN reported a decline in revenue and an increase in net loss for the fourth quarter. Therefore, the reported revenue for the quarter was $0.2 million against the comparable $1.2 million in Q4 2020. A major contributor to this decline in revenue was a row down in clinical trial and grant revenue.

    Moreover, the net loss stood at $4.1 million for the quarter with a per-share loss increasing to 2 cents.

  • Longeveron Inc. (LGVN) stock Surges Premarket a Day Before Earnings Report

    On March 10, Longeveron Inc. (LGVN) stock surged by 26.73% in the premarket, at the last check. The company is set to declare its Q4 and fiscal 2021 financial results on March 11, 2022, before the opening of the market. The company will be hosting the earnings conference call tomorrow at 8:20 am, EST during which corporate updates would also be provided.

    Source: Plus500

    In the previous trading session, the stock remained bullish with a gain of 39.72%. The volume of the shares traded during the session was above the average at 2.33 million shares. LGVN closed the session at a price of $7.07 on Wednesday. At the time of writing, the stock was trading at a price of $8.96 per share in the premarket, on Thursday.

    The clinical-stage biotechnology company, Longeveron Inc. was founded in 2014. Currently, the company has a market capitalization of $99.59 million with its 3.98 million shares outstanding.

    What is Happening with LGVN?

    LGVN stock had been in a downtrend since March 02 while there has been no recent news other than investor conference participation and upcoming earnings. The stock continued its downtrend till March 08 as it reached a low of $5.05. The stock reached such a low price after over a hundred days. Thus, the low price attracted investors towards the stock the following day on March 09. It seems investors are taking advantage of the recent low to stock up the shares of LGVN before the upcoming earnings. While it is uncertain what the cards hold for the stock after the company releases 2021 year-end earnings tomorrow, presently it is enjoying good fortune.

    With a year-to-date loss of 41.43%, the start of 2022 has not been fruitful for the stock so far. Last year, LGVN suffered a downtrend of over 16.3%.

    Recent Participations

    Recently, the company participated in the Q1 virtual Investor Summit, the exclusive smallcap and microcap companies event for connecting with investors. The company’s Chief Executive Officer, Geoff Green presented at the summit on March 8, 2022.

    Before this, the company’s management also participated and presented at the Phacilitate’s Advanced Therapies Week from January 25-28, 2022.

    LGVN’s Recent Board Addition

    On February 17, LGVN announced appointing Todd Girolamo to its Board of Directors. Mr. Girolamo is currently serving as the Chief Legal Officer, Vice President of Corporate Development, and Corporate Secretary for Caladrius Biosciences, Inc.

  • Longeveron Inc. (LGVN) stock went up in the current trading session; here’s what recently happened

    Longeveron Inc. (LGVN) stock was rising 10.84% to trade at $7.87 in the current market at the time of writing.  LGVN’s stock closed at $6.92 in the previous session. The LGVN stock volume traded at a total of 14.95 million shares.

    Longeveron’s overall background and lead product development

    Longeveron is a clinical biotechnology company that specifically focuses on innovating and uniquely approaching the design, production, and testing of its therapies. The company differentiates its therapies by working on specific age-related and life threatening conditions.

    LGVN stock’s lead product is LOMECEL-BTM which is still in the developmental and trial phase. LOMECEL-BTMtherapy works as a cell-based product. It is a product derived through the culture-expanded medical signaling cells. These MSCs are then sourced from healthy and fit adult donors’ bone marrows. The concept behind the therapy for Longeveron’s product is that the cells that are associated with the function of tissue and organ repair, immune system function and maintenance, then it is possible to use them to procreate the same effects in therapies. The cell-based therapy would be used for the application of diseases and disorders that come with the aging process and other medical disorder.

    The recent news on LGVN stock

    On 13th April 2021, the LGVN stock announced that it has achieved primary safety endpoints of phase I clinical study of Lomecel-B cell for Alzheimer’s disease. The study has shown positive results which validate the secondary efficacy evaluation support potential benefit for Lomecel-B.

    The details in the press release of the Clinical Phase I trial indicated the “use of a randomized, placebo-controlled double-blind design which tested the single i.v of Lomecel-B 20 million cells and Lomecel-N 100 million cells or placebo”. The test studied the subjects for 52 weeks post the administration and fusion of the therapy. The trial was funded partly by an Alzheimer’s Association Part the Cloud Challenge on Neuroinflammationgrant.

    • Highlights of the key findings and preliminary data show that:
    • Lomecel-B’s trial test showed that it did not develop any treatment-related serious side-effects through the 1-year follow-up.
    • The average MME score that measures cognitive functioning, declined more slowly in low dosage of Lomecel-B and quicker in the placebo effect.
    • 26 weeks post the infusion time, patients in the low-dose Lomecel-B group showed significantly higher average score on the QOL-AD along with better ADCS-ADL measures as compared to the placebo group.

    Longeveron’s current and future prospects

    The investigative products of Longeveron are currently in phase 1 and 2 trials clinically and are being developed for the indication of: Aging Frailty, Alzheimer’s disease, Metabolic Syndrome, ARDS, and HLHS.

    The company reported its financial outlook; the first quarter of 2021 saw an increased cash asset by $29.1 million through IPO funds. The cash position was $24.5 million as of 30th March 2021. The prediction by the company is that based on current operating plans the capital will be enough to drive them through the fourth quarter of 2022.

    The main current aim of LGVN stock is to advance all of its cell-based candidates including LOMECEL-BTM into the defining phase 3 trials along with completing the approval staging processes as well as commercialization phase. These successful developments in its operation boost the LGVN stock’s value.