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
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.
Longeveron (NASDAQ: LGVN) ha annunciato che il cofondatore e Chief Science Officer Dr. Joshua Hare è stato intervistato da NPR's BioTech Nation riguardo la sindrome dell'ipoplasticità del cuore sinistro (HLHS) e la terapia sperimentale con cellule staminali di Longeveron, laromestrocel. L'azienda ha comunicato che il suo trial chiave di fase 2b ELPIS II è completamente reclutato e i risultati primari sono attesi nel Q3 2026. ELPIS II segue ELPIS I, in cui i bambini trattati hanno registrato 100% di sopravvivenza senza trapianto entro cinque anni rispetto a circa un 20% tasso di mortalità dai controlli storici. Il trial è condotto con NHLBI tramite sovvenzioni NIH. L'FDA ha precedentemente designato laromestrocel come Orphan Drug, Fast Track, e Rare Pediatric Disease, e nell'agosto 2024 ha confermato ELPIS II come trial cruciale che potrebbe supportare una BLA se l'efficacia è dimostrata.
Longeveron (NASDAQ: LGVN) anunció que el cofundador y Director Científico Dr. Joshua Hare fue entrevistado en NPR’s BioTech Nation sobre la hipoplástica del síndrome del ventrículo izquierdo (HLHS) y la terapia con células madre en investigación de Longeveron, laromestrocel. La empresa dijo que su ensayo pivotal de fase 2b ELPIS II está completamente inscrito y se esperan resultados principales en Q3 2026. ELPIS II sigue a ELPIS I, donde los niños tratados experimentaron una supervivencia libre de trasplante del 100% a cinco años frente a una tasa de mortalidad aproximada del 20% en controles históricos. El ensayo se realiza con NHLBI a través de subvenciones de NIH. La FDA designó previamente a laromestrocel como Orphan Drug, Fast Track, y Rare Pediatric Disease, y en agosto de 2024 confirmó ELPIS II como ensayo pivotal que podría respaldar una BLA si se demuestra eficacia.
Longeveron (NASDAQ: LGVN) 는 공동 창립자이자 최고 과학 책임자 Dr. Joshua Hare가 NPR의 BioTech Nation에 HLHS(좌심실 발달 부전 증후군) 및 Longeveron의 연구용 줄기세포 치료제 laromestrocel에 대해 인터뷰했다고 발표했습니다. 회사는 핵심 2b상 시험 ELPIS II가 완전히 등록됐다고 말했으며 상위 결과는 2026년 3분기에 기대된다고 했습니다. ELPIS II는 ELPIS I을 따라 치료를 받은 아이들이 5년 간 이식 없이 생존한 비율이 100%였고, 역사 대조군의 약 20% 사망률에 비해 높았습니다. 이 시험은 NIH 보조금을 통해 NHLBI와 함께 진행됩니다. FDA는 이전에 laromestrocel을 고아약, 패스트 트랙, 그리고 희귀 소아 질환으로 지정했으며, 2024년 8월에는 ELPIS II를 주요 시험으로 확인하여 효능이 입증되면 BLA를 지원할 수 있다고 밝혔습니다.
Longeveron (NASDAQ: LGVN) a annoncé que le cofondateur et Directeur Scientifique Dr. Joshua Hare a été interviewé sur BioTech Nation de NPR au sujet du syndrome du cœur gauche hypoplasique (HLHS) et de la thérapie par cellules souches expérimentale de Longeveron, laromestrocel. L'entreprise a déclaré que son essai pivot de phase 2b ELPIS II est entièrement enrôlé et les résultats préliminaires sont attendus au T3 2026. ELPIS II suit ELPIS I, où les enfants traités ont connu 100% de survie sans transplantation jusqu'à cinq ans contre environ 20% de mortalité selon les témoins historiques. L'essai est mené avec le NHLBI via des subventions NIH. La FDA avait auparavant désigné laromestrocel comme Orphan Drug, Fast Track, et Rare Pediatric Disease, et en août 2024 a confirmé ELPIS II comme essai pivot qui pourrait soutenir une BLA si l'efficacité est démontrée.
Longeveron (NASDAQ: LGVN) kündigte an, dass Mitgründer und Chief Science Officer Dr. Joshua Hare im NPR-BioTech Nation zu Hypoplastischer Linksherzsyndrom (HLHS) und Longeverons experimenteller Stammzellen-Therapie laromestrocel interviewt wurde. Das Unternehmen sagte, dass seine entscheidende Phase-2b-Studie ELPIS II vollständig eingeschrieben ist und die Endergebnisse im Q3 2026 erwartet werden. ELPIS II folgt ELPIS I, bei dem behandelte Kinder 100% transplantationsfreie Überlebensrate bis zu fünf Jahren erfuhren, gegenüber einer historischen Kontrolldor etwa 20% Mortalitätsrate. Die Studie wird mit dem NHLBI über NIH-Zuschüsse durchgeführt. Die FDA hat laromestrocel zuvor als Orphan Drug, Fast Track, und Rare Pediatric Disease bezeichnet, und im August 2024 bestätigte sie ELPIS II als pivotalen Trial, das eine BLA unterstützen könnte, wenn die Wirksamkeit nachgewiesen wird.
Longeveron (NASDAQ: LGVN) أعلن أن المؤسس المشارك ورئيس العلوم الدكتور جoshua Hare تم مقابلته في NPR's BioTech Nation حول متلازمة خلل القلب الأيسر تحت التطور (HLHS) وعلاج الخلايا الجذعية التجريبي لشركة Longeveron، laromestrocel. وقالت الشركة إن تجربة المرحلة 2b المحورية ELPIS II مكتملة التسجيل وتتوقع النتائج الأولية في الربع الثالث من 2026. يتبع ELPIS II ELPIS I، حيث شهد الأطفال المعالجون بقاء بدون زرع بنسبة 100% حتى خمس سنوات مقابل معدل وفيات تقريبي 20% من الضوابط التاريخية. التجربة تجرى مع NHLBI من خلال منح NIH. وسبق أن منحت FDA laromestrocel لقب دواء يتيم، المسار السريع، و مرض نادر في الأطفال، وفي أغسطس 2024 أكدت أن ELPIS II تجربة حاسمة يمكن أن تدعم BLA إذا تم إثبات الفاعلية.
Longeveron (NASDAQ: LGVN) 公布联合创始人兼首席科学官 Dr. Joshua Hare 接受 NPR 的 BioTech Nation 的采访，讨论 HLHS（左心室发育不全综合征）以及 Longeveron 的研究性干细胞治疗药物 laromestrocel。公司表示其关键的 2b 期试验 ELPIS II 已完成招募，预计顶线结果将在 2026 年第三季度 公布。ELPIS II 继 ELPIS I 之后，接受治疗的儿童在五年内实现 100% 无需移植的存活率，而历史对照组的约 20% 死亡率。该试验由 NHLBI 通过 NIH 资助进行。FDA 之前将 laromestrocel 指定为 孤儿药、快速通道，以及 罕见儿科疾病，并在 2024 年 8 月确认 ELPIS II 为关键试验，如果显示疗效则可能支持 BLA。
- 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
- 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
Insights
Fully enrolled pivotal Phase 2b trial with prior positive signal; top-line results due
Longeveron reports full enrollment in the pivotal ELPIS II trial testing laromestrocel for hypoplastic left heart syndrome, a rare univentricular pediatric disease that typically requires three surgeries. The program builds on ELPIS I where treated children showed
The trial’s pivotal designation by the FDA and NIH collaboration increase regulatory and operational relevance, and the company cites Orphan, Fast Track, and Rare Pediatric Drug designations. Key dependencies include the integrity of the ELPIS II dataset, comparator context versus historical controls, and whether top-line results meet the FDA’s stated evidentiary bar for a BLA.
Watch for the top-line readout in
- 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
FAQ
What did Longeveron announce about ELPIS II (LGVN) on October 27, 2025?
What were the ELPIS I results referenced by Longeveron (LGVN)?
How could ELPIS II affect Longeveron’s regulatory path for laromestrocel (LGVN)?
When are Longeveron’s ELPIS II top‑line results expected and what is the ticker?
Who is collaborating with Longeveron on ELPIS II and how is it funded?
