Longeveron® Co-Founder and Chief Science Officer Dr. Joshua Hare Interviewed on NPR’s BioTech Nation Discussing Potential Breakthrough Stem Cell Therapy for Hypoplastic Left Heart Syndrome (HLHS), a Rare Pediatric Congenital Heart Defect
Rhea-AI Summary
Longeveron (NASDAQ: LGVN) announced that Co‑founder and Chief Science Officer Dr. Joshua Hare was interviewed on NPR’s BioTech Nation about hypoplastic left heart syndrome (HLHS) and Longeveron’s investigational stem cell therapy, laromestrocel. The company said its pivotal Phase 2b trial ELPIS II is fully enrolled and top‑line results are anticipated in Q3 2026. ELPIS II follows ELPIS I, where treated children experienced 100% transplant‑free survival to five years versus an approximate 20% mortality rate from historical controls. The trial is conducted with NHLBI via NIH grants. The FDA previously designated laromestrocel as Orphan Drug, Fast Track, and Rare Pediatric Disease, and in August 2024 confirmed ELPIS II as a pivotal trial that could support a BLA if efficacy is demonstrated.
Positive
- ELPIS II fully enrolled pivotal Phase 2b trial
- Top‑line results expected in Q3 2026
- ELPIS I showed 100% transplant‑free survival to five years in treated children
- FDA confirmed ELPIS II could support a BLA if efficacy is sufficient
- Collaboration with NHLBI via NIH grants
Negative
- No pivotal efficacy data yet—top‑line results pending Q3 2026
- FDA acceptance for BLA is conditional: ”if it demonstrates sufficient evidence of efficacy”
- Efficacy comparison referenced historical control data rather than a randomized control
News Market Reaction – LGVN
In the Oct 27 session, LGVN declined 0.33%, reflecting a mild negative market reaction.
Data tracked by StockTitan Argus on the day of publication.
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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
MIAMI, Oct. 27, 2025 (GLOBE NEWSWIRE) -- 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
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
