Longeveron® to Attend Alliance for Regenerative Medicine’s Cell & Gene Meeting on the Mesa
Longeveron (NASDAQ: LGVN) announced its participation in the Alliance for Regenerative Medicine's Cell & Gene Meeting on the Mesa, taking place October 6-8, 2025 in Phoenix, Arizona. The company will explore potential partnerships for its Alzheimer's disease stem cell therapy program, laromestrocel.
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.
Longeveron (NASDAQ: LGVN) ha annunciato la propria partecipazione al Cell & Gene Meeting on the Mesa, organizzato dall'Alliance for Regenerative Medicine, che si svolgerà 6-8 ottobre 2025 a Phoenix, in Arizona. L'azienda valuterà potenziali partnership per il suo programma di terapia con cellule staminali per l'Alzheimer, laromestrocel.
Il trial di fase 2a (CLEAR MIND) ha mostrato risultati positivi, evidenziando un rallentamento complessivo della progressione della malattia rispetto al placebo. La FDA ha concesso a laromestrocel sia la designazione RMAT (Regenerative Medicine Advanced Therapy) sia la designazione Fast Track per il trattamento dell'Alzheimer lieve. A seguito di un incontro di tipo B con la FDA nel marzo 2025, è stato raggiunto un allineamento su un unico disegno di studio pivotale di fase 2/3 che potrebbe supportare la presentazione di una richiesta di BLA.
Longeveron (NASDAQ: LGVN) anunció su participación en el Cell & Gene Meeting on the Mesa de la Alliance for Regenerative Medicine, que se celebrará del 6 al 8 de octubre de 2025 en Phoenix, Arizona. La compañía explorará posibles alianzas para su programa de terapia con células madre para la enfermedad de Alzheimer, laromestrocel.
El ensayo de fase 2a (CLEAR MIND) mostró resultados positivos, con un enlentecimiento general de la progresión de la enfermedad respecto al placebo. La FDA ha concedido a laromestrocel la designación RMAT (Regenerative Medicine Advanced Therapy) y la designación Fast Track para el tratamiento del Alzheimer leve. Tras una reunión positiva de tipo B con la FDA en marzo de 2025, se acordó un diseño único de ensayo pivotal de fase 2/3 que podría respaldar la presentación de una BLA.
Longeveron (NASDAQ: LGVN)은 Alliance for Regenerative Medicine의 Cell & Gene Meeting on the Mesa에 참가한다고 발표했습니다. 행사는 2025년 10월 6-8일 애리조나주 피닉스에서 열립니다. 회사는 알츠하이머 병 줄기세포 치료제 프로그램인 laromestrocel의 잠재적 파트너십을 모색할 예정입니다.
2상 2a상(CLEAR MIND) 임상은 위약 대비 질병 진행의 전반적 감소를 보이며 긍정적인 결과를 보여주었습니다. FDA는 경미한 알츠하이머 치료를 위한 laromestrocel에 RMAT(재생의료 고급 치료) 및 Fast Track 지정을 부여했습니다. 2025년 3월 FDA와의 Type B 회의 후, 2/3상 단일 핵심 설계에 합의했으며 이는 BLA 제출을 뒷받침할 수 있습니다.
Longeveron (NASDAQ: LGVN) a annoncé sa participation à la Cell & Gene Meeting on the Mesa de l’Alliance for Regenerative Medicine, qui se tiendra du 6 au 8 octobre 2025 à Phoenix (Arizona). L’entreprise étudiera des partenariats potentiels pour son programme de thérapie par cellules souches contre la maladie d’Alzheimer, laromestrocel.
L’essai clinique de phase 2a (CLEAR MIND) a montré des résultats positifs, avec un ralentissement global de la progression de la maladie par rapport au placebo. La FDA a accordé à laromestrocel à la fois la désignation RMAT (Regenerative Medicine Advanced Therapy) et la désignation Fast Track pour le traitement de l’Alzheimer léger. Suite à une réunion de type B positive avec la FDA en mars 2025, un plan unique de trial pivotale de phase 2/3 a été validé, susceptible de soutenir une soumission BLA.
Longeveron (NASDAQ: LGVN) kündigte seine Teilnahme an der Cell & Gene Meeting on the Mesa der Alliance for Regenerative Medicine an, die vom 6. bis 8. Oktober 2025 in Phoenix, Arizona, stattfinden wird. Das Unternehmen wird potenzielle Partnerschaften für sein Alzheimer-Krankheit-Stammzelltherapie-Programm laromestrocel prüfen.
Der Phase-2a-Test (CLEAR MIND) zeigte positive Ergebnisse und verzeichnete eine insgesamt verlangsamte Krankheitsprogression gegenüber Placebo. Die FDA hat laromestrocel sowohl die RMAT-Deklaration (Regenerative Medicine Advanced Therapy) als auch die Fast-Track-Deklaration für die Behandlung von mildem Alzheimer erteilt. Nach einem positiven Type-B-Gespräch mit der FDA im März 2025 wurde ein einzelnes, pivotales Phase-2/3-Studiendesign vereinbart, das eine BLA-Einreichung unterstützen könnte.
Longeveron (NASDAQ: LGVN) أعلنت مشاركتها في اجتماع الخلية والجين التابع لتحالف الطب التجديدي، Cell & Gene Meeting on the Mesa، الذي سيعقد من 6 إلى 8 أكتوبر 2025 في فينيكس، أريزونا. ستستكشف الشركة شراكات محتملة لبرنامجها العلاجي بالخلايا الجذعية لمرض الزهايمر، laromestrocel.
أظهر تجربة المرحلة 2a (CLEAR MIND) نتائج إيجابية، مع تباطؤ عام في تقدم المرض مقارنة بالدواء الوهمي. منحت FDA لlaromestrocel كل من التعيين RMAT (العلاج الطبي المتقدم للطب التجديدي) وتعيين Fast Track لعلاج الزهايمر الخفيف. عقب اجتماع من النوع B إيجابي مع FDA في مارس 2025، تم التوصل إلى توافق حول تصميم تجريبي محوري من المرحلة 2/3 يمكن أن يدعم تقديم طلب BLA.
Longeveron (NASDAQ: LGVN) 宣布将参加再生医学联盟的细胞与基因会议（Cell & Gene Meeting on the Mesa），会议将于 2025 年 10 月 6-8 日 在亚利桑那州菲尼克斯举行。公司将探索其阿尔茨海默病干细胞治疗计划 laromestrocel 的潜在合作伙伴。
其二期 2a 期临床（CLEAR MIND）显示积极结果，整体上相较于安慰剂实现了疾病进展的放缓。FDA 已给予 laromestrocel RMAT（再生医学高级治疗）与 Fast Track 的指定，用于轻度阿尔茨海默病治疗。经过 2025 年 3 月与 FDA 的 Type B 会议后，双方对一个单一、关键的二/三期临床试验设计达成一致，可能支持提交生物制剂许可申请（BLA）。
- Phase 2a CLEAR MIND trial achieved primary safety and secondary efficacy endpoints
- FDA granted both RMAT and Fast Track designations for laromestrocel
- Positive Type B FDA meeting with clear pathway to BLA submission
- Study results published in prestigious Nature Medicine journal
- None.
- Exploring potential partnerships and strategic opportunities for the Company’s stem cell therapy program in Alzheimer’s disease
- Alzheimer’s disease development program with positive data in successful Phase 1 and Phase 2a clinical trials
- Clear regulatory pathway following positive Type B meeting with U.S. FDA
- FDA has granted laromestrocel both Regenerative Medicine Advanced Therapy (RMAT) designation and Fast Track designation for the treatment of mild Alzheimer’s disease
MIAMI, Sept. 22, 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 it will participate in the Alliance for Regenerative Medicine’s Cell & Gene Meeting on the Mesa taking place October 6-8, 2025 in Phoenix, Arizona.
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):
- Positive data from successful Phase 1 and Phase 2a AD clinical trials.
- Results from the Phase 2a clinical trial (CLEAR MIND), which support the therapeutic potential of laromestrocel in the treatment of mild Alzheimer’s disease and provided evidence-based support for further clinical development, were published in the peer reviewed journal Nature Medicine in March 2025.
- Positive Type B meeting with FDA regarding pathway to BLA submission for laromestrocel in Alzheimer’s disease held in March 2025 with alignment reached on proposed trial study design, population and endpoints for a single, pivotal Phase 2/3 clinical trial that if positive, could be acceptable for BLA submission for Alzheimer’s disease.
- The FDA has granted laromestrocel both Regenerative Medicine Advanced Therapy (RMAT) designation and Fast Track designation for the treatment of mild Alzheimer’s disease.
To schedule a meeting with the Longeveron team during the conference, please use the conference partnering system, or email info@longeveron.com.
Laromestrocel Alzheimer’s Disease Program
Longeveron’s lead investigational therapeutic candidate is laromestrocel, a proprietary, scalable, allogeneic cellular therapy. In a completed Phase 2a clinical trial (CLEAR MIND) in mild Alzheimer’s disease, laromestrocel treated patients showed an overall slowing/prevention of disease worsening compared to placebo. The trial achieved the primary safety and secondary efficacy endpoints and showed statistically significant improvements in pre-specified clinical and biomarker endpoints in specific laromestrocel groups compared to placebo. These results support the therapeutic potential of laromestrocel in the treatment of mild Alzheimer’s disease and provided evidence-based support for further clinical development.
Full results from the CLEAR MIND study were presented in a featured research oral presentation at the 2024 Alzheimer's Association International Conference (AAIC). Longeveron previously announced top-line results for CLEAR MIND on October 5, 2023, and reported additional clinical data and imaging biomarker results from CLEAR MIND on December 20, 2023.
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.
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
FAQ
What are the key results from Longeveron's CLEAR MIND Phase 2a trial for Alzheimer's disease?
What regulatory designations has Longeveron (LGVN) received for laromestrocel?
When and where will Longeveron present at the Cell & Gene Meeting on the Mesa?
What is the next development step for Longeveron's laromestrocel in Alzheimer's disease?
Where were Longeveron's CLEAR MIND trial results published?
