Longeveron® Named XPRIZE Healthspan Semifinalist and Top 40 Milestone 1 Award Recipient
Longeveron (NASDAQ: LGVN) has been selected as a Semi-Finalist and received a $250,000 Milestone 1 Award in the XPRIZE Healthspan competition, a $101 million global initiative aimed at revolutionizing human aging treatment. The company's stem cell therapy laromestorcel has shown positive initial results across 5 clinical trials in 3 indications: Alzheimer's Disease, Aging-related Frailty, and Hypoplastic Left Heart Syndrome (HLHS).
The therapy has received five FDA designations, including Orphan Drug, Fast Track, and Rare Pediatric Disease designations for HLHS, plus RMAT and Fast Track designations for Alzheimer's Disease. As a semifinalist, Longeveron is now eligible to compete for a $1 million milestone prize and a grand prize ranging from $61-81 million.
Longeveron (NASDAQ: LGVN) è stata selezionata come semifinalista e ha ricevuto un premio Milestone 1 di 250.000 dollari nella competizione XPRIZE Healthspan, un'iniziativa globale da 101 milioni di dollari volta a rivoluzionare il trattamento dell'invecchiamento umano. La terapia con cellule staminali dell'azienda, laromestorcel, ha mostrato risultati iniziali positivi in 5 studi clinici su 3 indicazioni: Morbo di Alzheimer, Fragilità correlata all'invecchiamento e Sindrome del Cuore Sinistro Ipoplastico (HLHS).
La terapia ha ottenuto cinque designazioni dalla FDA, tra cui Orphan Drug, Fast Track e Rare Pediatric Disease per HLHS, oltre a RMAT e Fast Track per il Morbo di Alzheimer. In qualità di semifinalista, Longeveron è ora idonea a competere per un premio milestone da 1 milione di dollari e per un premio finale che varia da 61 a 81 milioni di dollari.
Longeveron (NASDAQ: LGVN) ha sido seleccionada como semifinalista y recibió un premio de hito 1 de 250,000 dólares en la competencia XPRIZE Healthspan, una iniciativa global de 101 millones de dólares destinada a revolucionar el tratamiento del envejecimiento humano. La terapia con células madre de la compañía, laromestorcel, ha mostrado resultados iniciales positivos en 5 ensayos clínicos en 3 indicaciones: enfermedad de Alzheimer, fragilidad relacionada con la edad y síndrome del corazón izquierdo hipoplásico (HLHS).
La terapia ha recibido cinco designaciones de la FDA, incluyendo Orphan Drug, Fast Track y Rare Pediatric Disease para HLHS, además de RMAT y Fast Track para la enfermedad de Alzheimer. Como semifinalista, Longeveron ahora es elegible para competir por un premio de hito de 1 millón de dólares y un gran premio que oscila entre 61 y 81 millones de dólares.
Longeveron (NASDAQ: LGVN)은(는) XPRIZE Healthspan 대회에서 준결승 진출자로 선정되어 25만 달러의 마일스톤 1 상을 받았습니다. 이 대회는 인간 노화 치료 혁신을 목표로 하는 1억 1천만 달러 규모의 글로벌 이니셔티브입니다. 회사의 줄기세포 치료제 라로메스토셀은 알츠하이머병, 노화 관련 허약, 그리고 저형성 좌심증후군(HLHS) 등 3가지 적응증에 대해 5건의 임상시험에서 긍정적인 초기 결과를 보였습니다.
이 치료제는 FDA로부터 희귀의약품, 신속심사(Fast Track), 희귀 소아질환 등 HLHS 관련 3가지 지정과 알츠하이머병 관련 RMAT 및 신속심사 지정 등 총 5가지 지정받았습니다. 준결승 진출자로서 Longeveron은 이제 100만 달러의 마일스톤 상과 6100만에서 8100만 달러의 대상을 놓고 경쟁할 자격이 주어졌습니다.
Longeveron (NASDAQ : LGVN) a été sélectionnée comme demi-finaliste et a reçu une récompense Milestone 1 de 250 000 dollars dans le cadre du concours XPRIZE Healthspan, une initiative mondiale de 101 millions de dollars visant à révolutionner le traitement du vieillissement humain. La thérapie par cellules souches de la société, laromestorcel, a montré des résultats initiaux positifs dans 5 essais cliniques portant sur 3 indications : la maladie d'Alzheimer, la fragilité liée à l'âge et le syndrome du cœur gauche hypoplasique (HLHS).
Cette thérapie a obtenu cinq désignations de la FDA, dont Orphan Drug, Fast Track et Rare Pediatric Disease pour le HLHS, ainsi que RMAT et Fast Track pour la maladie d'Alzheimer. En tant que demi-finaliste, Longeveron est désormais éligible pour concourir pour un prix de jalon d'un million de dollars et un grand prix allant de 61 à 81 millions de dollars.
Longeveron (NASDAQ: LGVN) wurde als Halbfinalist ausgewählt und erhielt eine Milestone-1-Auszeichnung in Höhe von 250.000 US-Dollar im Rahmen des XPRIZE Healthspan Wettbewerbs, einer globalen Initiative mit einem Volumen von 101 Millionen US-Dollar, die darauf abzielt, die Behandlung des menschlichen Alterns zu revolutionieren. Die Stammzelltherapie des Unternehmens, laromestorcel, zeigte in 5 klinischen Studien bei 3 Indikationen positive erste Ergebnisse: Alzheimer-Krankheit, altersbedingte Gebrechlichkeit und hypoplastisches Linksherzsyndrom (HLHS).
Die Therapie erhielt fünf FDA-Designationen, darunter Orphan Drug, Fast Track und Rare Pediatric Disease für HLHS sowie RMAT- und Fast Track-Designationen für Alzheimer. Als Halbfinalist ist Longeveron nun berechtigt, um einen Meilensteinpreis von 1 Million US-Dollar und einen Hauptpreis im Bereich von 61 bis 81 Millionen US-Dollar zu konkurrieren.
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Insights
Longeveron receives $250K XPRIZE award and semifinalist status, boosting credibility for its stem cell therapy programs in Alzheimer's and rare diseases.
Longeveron's selection as an XPRIZE Healthspan semifinalist represents a significant external validation for their regenerative medicine platform. The company has secured a
The XPRIZE recognition is particularly meaningful as it follows a rigorous evaluation process that assessed scientific merit among over 600 applicants from 58 countries. This selection indicates that independent experts believe Longeveron's approach to stem cell therapy shows feasible potential to address age-related degradation.
From a development perspective, their lead candidate laromestorcel has accumulated impressive regulatory support with five distinct FDA designations across multiple indications. The dual Fast Track designations for both Alzheimer's and HLHS programs signal the FDA's recognition of unmet medical needs in these areas and potentially expedited review pathways.
The RMAT designation for Alzheimer's is especially noteworthy as it requires preliminary clinical evidence indicating potential to address unmet medical needs for serious conditions. This suggests their clinical data to date has demonstrated meaningful signals of efficacy.
For investors, this external validation comes with both immediate financial impact (
- Longeveron selected as a Top 40 Semifinalist based on the feasibility of its stem cell therapy
- Stem cell therapy laromestorcel being evaluated as potential treatment for Alzheimer’s disease and HLHS, a rare pediatric disease and orphan-designated indication
MIAMI, May 12, 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 has been selected as a Semi-Finalist Team and one of the Top 40 Teams receiving a
“We’re proud to be a Semifinalist team of XPRIZE Healthspan, a 7-year,
Mr. Hashad commented further, “Our stem cell therapy laromestorcel has delivered several positive initial results across 5 clinical trials in 3 indications - Alzheimer’s Disease, Aging-related Frailty, and Hypoplastic Left Heart Syndrome (HLHS), a rare pediatric and orphan-designated disease. Based on positive initial data, laromestorcel development programs have received five U.S. FDA designations: for the HLHS program - Orphan Drug designation, Fast Track designation, and Rare Pediatric Disease designation; and, for the Alzheimer’s Disease program - Regenerative Medicine Advanced Therapy (RMAT) designation and Fast Track designation.”
XPRIZE team applications were rigorously evaluated for scientific merit to identify the best, most feasible, and safe approaches to increase human healthspan. The top 100 Teams of more than 600 applicants across 58 countries are all considered Semifinalists, and presented a single or combination therapeutic approach that demonstrates feasibility and potential to restore or preserve muscular, cognitive, and immune function lost to age-related degradation by at least 10 years, with an ambitious goal of 20 years, and deliver their therapy in 1-year or less in adults aged 50-80 years who are free of major or life-threatening disease and disability. The Top 40 Milestone 1 Award-winning teams are each receiving
XPRIZE Healthspan
Increasing human life expectancy is one of the greatest breakthroughs in modern history. We have more than doubled the global average in the last 100 years, but the length of our healthy lives has not increased at the same rate.
XPRIZE Healthspan is a 7-year,
About XPRIZE
XPRIZE is the recognized global leader in designing and executing large-scale competitions to solve humanity’s greatest challenges. For 30 years, our unique model has democratized crowd-sourced innovation and scientifically scalable solutions that accelerate a more equitable and abundant future. Donate, learn more, and co-architect a world of abundance with us at XPRIZE.org.
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 (Lomecel-B™) 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 three pipeline indications: hypoplastic left heart syndrome (HLHS), Alzheimer’s disease, 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.
Forward-Looking Statements
Certain statements in this press release that are not historical facts are forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, which reflect management’s current expectations, assumptions, and estimates of future operations, performance and economic conditions, and involve known and unknown risks, uncertainties, and other important factors that could cause actual results, performance, or achievements to differ materially from those anticipated, expressed, or implied by the statements made herein. Forward-looking statements are generally identifiable by the use of forward-looking terminology such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expects,” “intend,” “looks to,” “may,” “on condition,” “plan,” “potential,” “predict,” “preliminary,” “project,” “see,” “should,” “target,” “will,” “would,” or the negative thereof or comparable terminology, or by discussion of strategy or goals or other future events, circumstances, or effects and include, but are not limited to, statements about the various below-listed factors. Factors that could cause actual results to differ materially from those expressed or implied in any forward-looking statements in this release include, but are not limited to, our cash position and need to raise additional capital, the difficulties we may face in obtaining access to capital, and the dilutive impact it may have on our investors; our financial performance, and ability to continue as a going concern; the period over which we estimate our existing cash and cash equivalents will be sufficient to fund our future operating expenses and capital expenditure requirements; the ability of our clinical trials to demonstrate safety and efficacy of our product candidates, and other positive results; the timing and focus of our ongoing and future preclinical studies and clinical trials, and the reporting of data from those studies and trials; the size of the market opportunity for certain of our product candidates, including our estimates of the number of patients who suffer from the diseases we are targeting; our ability to scale production and commercialize the product candidate for certain indications; the success of competing therapies that are or may become available; the beneficial characteristics, safety, efficacy and therapeutic effects of our product candidates; our ability to obtain and maintain regulatory approval of our product candidates in the U.S. and other jurisdictions; our plans relating to the further development of our product candidates, including additional disease states or indications we may pursue; our plans and ability to obtain or protect intellectual property rights, including extensions of existing patent terms where available and our ability to avoid infringing the intellectual property rights of others; the need to hire additional personnel and our ability to attract and retain such personnel; and our estimates regarding expenses, future revenue, capital requirements and needs for additional financing.
Further information relating to factors that may impact the Company’s results and forward-looking statements are disclosed in the Company’s filings with the Securities and Exchange Commission, including Longeveron’s Annual Report on Form 10-K for the year ended December 31, 2024, filed with the Securities and Exchange Commission on February 28, 2025, its Quarterly Reports on Form 10-Q, and its Current Reports on Form 8-K. The Company operates in highly competitive and rapidly changing environment; therefore, new factors may arise, and it is not possible for the Company’s management to predict all such factors that may arise nor assess the impact of such factors or the extent to which any individual factor or combination thereof, may cause results to differ materially from those contained in any forward-looking statements. The forward-looking statements contained in this press release are made as of the date of this press release based on information available as of the date of this press release, are inherently uncertain, and the Company disclaims any intention or obligation, other than imposed by law, to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.
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/cfb4911d-2b0b-4c52-b2fa-b6982947155d
FAQ
What FDA designations has Longeveron (LGVN) received for laromestorcel?
How much did Longeveron (LGVN) receive as XPRIZE Healthspan Milestone 1 Award?
What conditions is Longeveron's laromestorcel being tested for?
What is the potential prize money Longeveron (LGVN) could win in the XPRIZE Healthspan competition?
