Nataliya Agafonova Nataliya Agafonova, M.D., Chief Medical Officer, Longeveron Accepted IND application allows for development program to move directly to a Phase 2 pivotal registration clinical trialPhase 2 clinical trial initiation anticipated in first half of 2026Pediatric cardiomyopathies affect at least 100,000 children worldwideEffective treatment options are limited, with nearly 40% of children with DCM requiring a heart transplant or dying within two years of diagnosis MIAMI, July 08, 2025 (GLOB ...

Mr. Powell to oversee Longeveron’s partnering and international strategy efforts MIAMI, June 26, 2025 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN), a clinical stage regenerative medicine biotechnology company developing cellular therapies for life-threatening and chronic aging-related conditions, today announced that it has appointed Than Powell as Chief Business Officer, effective July 7, 2025. In this role, he will lead the Company’s overall business strategy, Alzheimer’s disease program partnering ...

Nataliya Agafonova Nataliya Agafonova, M.D., Chief Medical Officer, Longeveron Top-line trial results are anticipated in the third quarter of 2026, after the final follow-up at 12-monthsLaromestrocel Biological License Application (BLA) submission for full traditional approval for HLHS anticipated in 2026, if ELPIS II results are positiveU.S. FDA has awarded laromestrocel HLHS program Rare Pediatric Disease designation, Orphan drug designation, and Fast track designationLaromestrocel HLHS program addres ...

MIAMI, June 09, 2025 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN), a clinical stage regenerative medicine biotechnology company developing cellular therapies for life-threatening and chronic aging-related conditions, today announced that Wa’el Hashad, CEO, will present at the H.C. Wainwright 6th Annual Neuro Perspectives Hybrid Conference, taking place June 16-17, 2025. Details for the Company’s corporate presentation: Pre-recorded presentation available on-demand Monday, June 16, at 7:00 a.m. ETLonge ...

Core Viewpoint - Longeveron Inc. is actively pursuing partnerships for its Alzheimer's disease program, which has shown promising results in clinical trials, particularly with its lead candidate, laromestrocel [2][5]. Company Overview - Longeveron Inc. is a clinical stage biotechnology company focused on developing regenerative medicines to address unmet medical needs, with laromestrocel as its lead investigational product [7]. - Laromestrocel is an allogeneic mesenchymal stem cell therapy derived from the bone marrow of young, healthy adult donors, with potential applications across various disease areas [7]. Clinical Trial Results - The Phase 2a clinical trial (CLEAR MIND) demonstrated that laromestrocel treated patients experienced an overall slowing or prevention of disease worsening compared to placebo, achieving primary safety and secondary efficacy endpoints [3][4]. - Statistically significant improvements were observed in pre-specified clinical and biomarker endpoints for specific laromestrocel groups compared to placebo [3]. Regulatory Designations - The FDA has granted laromestrocel both Regenerative Medicine Advanced Therapy (RMAT) designation and Fast Track designation for the treatment of mild Alzheimer's disease, facilitating greater access to FDA interactions during its development [5]. - Laromestrocel is noted as the first cellular therapeutic candidate to receive FDA RMAT designation for Alzheimer's disease [5]. Upcoming Events - Longeveron will participate in the BIO International Convention from June 16-19, 2025, to explore potential partnerships and strategic opportunities for its Alzheimer's disease program [1][2].

Longeveron (LGVN) Q1 2025 Earnings Call May 08, 2025 04:30 PM ET Company Participants Derek Cole - PresidentJoshua Hare - Co-Founder, Chief Science Officer & ChairmanWa'el Hashad - CEO & DirectorNataliya Agafonova - Chief Medical OfficerDevin Blass - SVP & CTOLisa Locklear - CFO & TreasurerRaghuram Selvaraju - Managing Director, Healthcare Equity Research Conference Call Participants Boobalan Pachaiyappan - Managing Director, Senior Research AnalystMichael Okunewitch - Senior Biotechnology Analyst Operator ...

Longeveron (LGVN) Q1 2025 Earnings Call May 08, 2025 04:30 PM ET Speaker0 a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Derek Cole of Investor Relations Advisory Solutions. Thank you. You may begin. Speaker1 Thank you, operator. Good afternoon, everyone, and thank you for joining us today to review Longgevron's twenty twenty five first quarter financial results and business update. After The U. S. Markets closed today, we issued a press release with financial r ...

Investor Presentation Nasdaq (LGVN) │ May 2025 Forward Looking Statements Certain statements in this press release that are not historical facts are forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, which reflect management's current expectations, assumptions, and estimates of future operations, performance and economic conditions, and involve known and unknown risks, uncertainties, and other important factors that could cause act ...

Wa'el Hashad Wa'el Hashad, CEO, Longeveron Pivotal Phase 2b clinical trial (ELPIS II) evaluating laromestrocel in HLHS, a rare pediatric disease and orphan-designated indication, has reached approximately 95% enrollment and is expected to complete enrollment in the second quarter of 2025Laromestrocel Biological License Application (BLA) submission for full traditional approval for HLHS anticipated in 2026, if ELPIS II is successfulResults from the Phase 2a clinical trial (CLEAR MIND) evaluating laromest ...

MIAMI, May 02, 2025 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN), a clinical stage regenerative medicine biotechnology company developing cellular therapies for life-threatening and chronic aging-related conditions, today announced that it will report first quarter 2025 financial results and provide a business update on Thursday, May 8, 2025 after the U.S. financial markets close. The Company will host a conference call and webcast the same day at 4:30 p.m. ET. Conference Call and Webcast Details: ...