Phase 2a results demonstrated laromestrocel (Lomecel-B™) improved cognitive function, quality of life, and brain volume in the treatment of mild Alzheimer's disease This encouraging clinical trial data adds to the body of evidence supporting the safety of single and multiple doses of laromestrocel (Lomecel-B™) treatment for mild Alzheimer's disease and provides indications of efficacy in combating decline of brain volume and potentially cognitive function Laromestrocel (Lomecel-B™) is, to Company's knowledge, the first cellular therapeutic candidate to receive U.S. FDA Regenerative Medicine Advanced Therapy (RMAT) designation for Alzheimer's disease MIAMI, March 11, 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 the publication in Nature Medicine of results from the CLEAR MIND Phase 2a clinical trial evaluating laromestrocel (Lomecel-B™) as a potential cellular therapy for mild Alzheimer's disease (AD). The article is also available online here.
MIAMI, March 05, 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 participate in the 37th Annual Roth Conference taking place March 17-18, 2025. Details for the Company's fireside chat: Date: Tuesday, March 18, 2025 Time: 9:00 – 9:25 a.m.
Longeveron Inc. (NASDAQ:LGVN ) Q4 2024 Earnings Conference Call February 28, 2025 4:30 PM ET Company Participants Derek Cole - IR, Advisory Solutions Wa'el Hashad - CEO Nataliya Agafonova - CMO Lisa Locklear - CFO Conference Call Participants Boobalan Pachaiyappan - ROTH Capital Partners Ram Selvaraju - H.C. Wainwright Michael Okunewitch - Maxim Group Operator Good day, and welcome to the Longeveron 2024 and Full Year Financial Results Conference Call.
Pivotal Phase 2b clinical trial (ELPIS II) evaluating Lomecel-B™ (laromestrocel) in Hypoplastic Left Heart Syndrome (HLHS), a rare pediatric disease and orphan-designated indication, has achieved more than 90% enrollment and is expected to complete enrollment in the second quarter of 2025 Lomecel-B™ Biological License Application (BLA) submission for full traditional approval anticipated in 2026, if ELPIS II is successful FDA meeting anticipated late in first quarter of 2025 to discuss possible development paths for Lomecel-B™ in mild Alzheimer's disease WHO International Nonproprietary Names (INN) Expert Committee approved “laromestrocel” for the non-proprietary name of Lomecel-B™ Total Revenue for 2024 increased 237% year-over-year to $2.4 million, primarily due to the successful initiation of contract manufacturing services and increased participant demand for the Bahamas Registry Trial Company to host conference call and webcast today at 4:30 p.m. ET MIAMI, Feb. 28, 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 reported financial results for the full-year ended December 31, 2024 and provided a business update.
Cellular therapy Lomecel-B™ has been granted an International Non-proprietary Name (INN) of “laromestrocel” on the INN List issued by the World Health Organization (WHO) Lomecel-B™ is a proprietary, scalable, allogeneic cellular therapy being evaluated in Alzheimer's disease and hypoplastic left heart syndrome (HLHS), a rare pediatric disease and orphan indication Lomecel-B™ first cellular therapeutic candidate to receive U.S. FDA Regenerative Medicine Advanced Therapy (RMAT) designation for Alzheimer's disease MIAMI, Feb. 18, 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 the International Nonproprietary Names (INN) Expert Committee of the World Health Organization approved “laromestrocel” for the non-proprietary name of the Company's cellular therapy Lomecel-B™. Commonly referred to as a generic name, each INN is a unique name used to identify pharmaceutical substances or active pharmaceutical ingredients.
MIAMI, Dec. 02, 2024 (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 participate in the Emerging Growth Virtual Conference taking place December 4-5, 2024. Details for the Company's presentation: Date: December 5, 2024 Time: 12:00 – 12:30 p.m.
Findings offer potential mechanistic and clinical insights in the development of cellular therapy Lomecel-B™ for mild Alzheimer's disease (AD) Lomecel-B™ capacity to inhibit MMP14 correlates with improved clinical and biomarker outcomes in mild AD Immunomodulatory and pro-vascular effects of Lomecel-B™ in mild AD potentially driven by ability to exert MMP14 inhibition which may protect TIE2 receptor integrity in human AD patients MIAMI, Oct. 29, 2024 (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 its submission entitled “Lomecel-B inhibition of MMP14 activity predicts Lomecel-B bioactivity in the treatment of mild Alzheimer's disease” was presented as a late breaking poster presentation at the 17th edition of the Clinical Trials on Alzheimer's Disease Conference (CTAD24) taking place October 29 -November 1, 2024 in Madrid, Spain. “As a medicinal signaling cell therapy that has multiple potential mechanisms of action to address inflammatory responses in the brain, Lomecel-B™ offers the potential to address the underlying pathology of Alzheimer's disease,” said Joshua Hare, M.D.
Oral presentation highlights findings that patients treated with Lomecel-B TM in ELPIS I, in an open-label follow-on study, experienced 5-year survival after stage 2 Glenn surgery of 100% with none requiring heart transplant; this compared to the largest data set from the Single Ventricle Reconstruction Trial which showed 83% survival, with a 5.2% heart transplantation rate ELPIS I met its primary endpoint of safety through 1-year post-treatment, with 100% survival rate, 100% transplant-free and patients maintained expected rate of growth one year after treatment Findings support cell based therapy as a potential adjunct to HLHS reconstruction surgery to improve clinical benefits and reduce the need for subsequent heart transplantation ELPIS II Phase 2b clinical trial is currently ongoing, further evaluating Lomecel-B TM as a potential adjunct therapy for HLHS versus standard of care alone MIAMI, Oct. 27, 2024 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN), a clinical stage biotechnology company developing regenerative medicines, today announced that its positive long-term transplant-free survival data from a multi-year follow-on study to the ELPIS I Phase 1 clinical trial were featured in an oral presentation at the Congenital Heart Surgeons' Society (CHSS) 51st Annual Meeting taking place October 27-28, 2024 in Chicago, Illinois. “HLHS is a devastating disease for patients and their families, so I am impressed and very encouraged to see the continued long-term survival of patients treated with Lomecel-BTM in the ELPIS I study,” said Sunjay Kaushal, M.D.
Longeveron Lomecel-B data in Alzheimer's disease selected for late breaking poster presentation at Clinical Trials on Alzheimer's Disease Conf (CTAD24).
Longeveron® Lomecel-B 5-Year Long-term Transplant-free Survival Data in HLHS Selected for Oral Presentation at the Congenital Heart Surgeons' Society Mtg.