Longeveron to explore partnerships for Alzheimer's stem cell therapy program.
PorAinvest
lunes, 22 de septiembre de 2025, 9:17 am ET1 min de lectura
LGVN--
Laromestrocel is an allogeneic mesenchymal stem cell (MSC) therapy product isolated from the bone marrow of young, healthy adult donors. The company's Phase 2a clinical trial (CLEAR MIND) demonstrated positive results, showing an overall slowing of disease progression compared to placebo. The FDA has granted laromestrocel both Regenerative Medicine Advanced Therapy (RMAT) designation and Fast Track designation for mild Alzheimer's treatment. Following a positive Type B meeting with the FDA in March 2025, alignment was reached on a single, pivotal Phase 2/3 clinical trial design that could support BLA submission.
At the conference, members of the Longeveron management team will host meetings with global pharmaceutical company executives to explore potential partnership and strategic opportunities for the Company’s stem cell therapy program in Alzheimer’s disease (AD). To schedule a meeting with the Longeveron team during the conference, please use the conference partnering system, or email info@longeveron.com.
Longeveron is currently pursuing four pipeline indications: hypoplastic left heart syndrome (HLHS), Alzheimer’s disease, Pediatric Dilated Cardiomyopathy (DCM), and Aging-related Frailty. Laromestrocel development programs have received five distinct and important FDA designations: for the HLHS program - Orphan Drug designation, Fast Track designation, and Rare Pediatric Disease designation; and, for the AD program - Regenerative Medicine Advanced Therapy (RMAT) designation and Fast Track designation.
For more information, visit www.longeveron.com or follow Longeveron on LinkedIn, X, and Instagram.
[1] https://www.stocktitan.net/news/LGVN/longeveron-to-attend-alliance-for-regenerative-medicine-s-cell-gene-5xicyiixf6gq.html
Longeveron Inc. is set to participate in the Alliance for Regenerative Medicine's Cell & Gene Meeting on the Mesa. The company's stem cell therapy program for Alzheimer's disease has shown positive results in Phase 1 and Phase 2a clinical trials. The FDA has granted Laromestrocel RMAT and Fast Track designations, providing a clear regulatory pathway. Longeveron will meet with pharmaceutical executives to explore potential partnerships and strategic opportunities.
Longeveron Inc. (NASDAQ: LGVN), a clinical stage biotechnology company focused on developing cellular therapies for life-threatening, rare pediatric, and chronic aging-related conditions, has announced its participation in the Alliance for Regenerative Medicine's Cell & Gene Meeting on the Mesa. The event will take place October 6-8, 2025, in Phoenix, Arizona. The company will be exploring potential partnerships and strategic opportunities for its Alzheimer's disease stem cell therapy program, laromestrocel, at the conference.Laromestrocel is an allogeneic mesenchymal stem cell (MSC) therapy product isolated from the bone marrow of young, healthy adult donors. The company's Phase 2a clinical trial (CLEAR MIND) demonstrated positive results, showing an overall slowing of disease progression compared to placebo. The FDA has granted laromestrocel both Regenerative Medicine Advanced Therapy (RMAT) designation and Fast Track designation for mild Alzheimer's treatment. Following a positive Type B meeting with the FDA in March 2025, alignment was reached on a single, pivotal Phase 2/3 clinical trial design that could support BLA submission.
At the conference, members of the Longeveron management team will host meetings with global pharmaceutical company executives to explore potential partnership and strategic opportunities for the Company’s stem cell therapy program in Alzheimer’s disease (AD). To schedule a meeting with the Longeveron team during the conference, please use the conference partnering system, or email info@longeveron.com.
Longeveron is currently pursuing four pipeline indications: hypoplastic left heart syndrome (HLHS), Alzheimer’s disease, Pediatric Dilated Cardiomyopathy (DCM), and Aging-related Frailty. Laromestrocel development programs have received five distinct and important FDA designations: for the HLHS program - Orphan Drug designation, Fast Track designation, and Rare Pediatric Disease designation; and, for the AD program - Regenerative Medicine Advanced Therapy (RMAT) designation and Fast Track designation.
For more information, visit www.longeveron.com or follow Longeveron on LinkedIn, X, and Instagram.
[1] https://www.stocktitan.net/news/LGVN/longeveron-to-attend-alliance-for-regenerative-medicine-s-cell-gene-5xicyiixf6gq.html
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