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- Laromestrocel is a proprietary, scalable, allogeneic cellular therapy being evaluated to improve the clinical outcomes of children with HLHS
- Full enrollment achieved for pivotal Phase 2b clinical trial (ELPIS II) evaluating laromestrocel as a potential adjunct treatment for HLHS, a rare pediatric disease and orphan-designated indication
- ELPIS II top-line trial results are anticipated in the third quarter of 2026
Longeveron Inc. (NASDAQ: LGVN), a clinical stage biotechnology company developing cellular therapies for life-threatening, rare pediatric and chronic aging-related conditions, today announced that Joshua M. Hare, MD, FACC, FAHA, Longeveron's Co-founder, Chief Science Officer and Executive Chairman was interviewed on National Public Radio's (NPR) BioTech Nation with Dr. Moira Gunn. They discussed the pediatric congenital heart defect hypoplastic left heart syndrome (HLHS), one of the most severe congenital heart defects, Longeveron's stem cell therapy, laromestrocel, and the on-going, fully enrolled pivotal Phase 2b clinical trial evaluating laromestrocel in HLHS. ELPIS II top-line trial results are anticipated in the third quarter of 2026.
HLHS is a rare univentricular disease that requires 3 open heart surgical procedures for treatment. Even with surgery, patients have a high rate of mortality or need for transplant by age 15. Laromestrocel is being evaluated for the potential to improve the clinical outcome of children with HLHS.
The interview is available here: BioTech Nation ... with Dr. Moira Gunn | Treating babies with congenital heart defects... Dr. Joshua Hare, Co-Founder and Chief Scientific Officer, Longeveron .
ELPIS II builds on the positive clinical results of ELPIS I, in which children in the trial experienced 100% transplant-free survival up to five years of age after receiving laromestrocel compared to approximate 20% mortality rate observed from historical control data. ELPIS II is being conducted in collaboration with the National Heart, Lung, and Blood Institute (NHLBI) through grants from the National Institutes of Health (NIH) . In August 2024, the U.S. Food and Drug Administration (FDA) confirmed that ELPIS II is a pivotal trial and, if it demonstrates sufficient evidence of efficacy, it would be acceptable for a Biologics License Application (BLA) submission for full traditional approval for HLHS. The FDA has granted laromestrocel Orphan Drug designation, Fast Track designation, and Rare Pediatric Disease designation for the treatment of HLHS.
About Longeveron Inc.
Longeveron is a clinical stage biotechnology company developing regenerative medicines to address unmet medical needs. The Company's lead investigational product is laromestrocel (Lomecel-B™), an allogeneic mesenchymal stem cell (MSC) therapy product isolated from the bone marrow of young, healthy adult donors. Laromestrocel has multiple potential mechanisms of action encompassing pro-vascular, pro-regenerative, anti-inflammatory, and tissue repair and healing effects with broad potential applications across a spectrum of disease areas. 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 .
Investor and Media Contact:
Derek Cole
Investor Relations Advisory Solutions
derek.cole@iradvisory.com
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/f106bde7-972a-4687-a91e-03e924f409fc
