Longeveron® to Attend BIO International Convention 2025
Longeveron (NASDAQ: LGVN) announced its participation in the BIO International Convention 2025 in Boston, where management will explore partnership opportunities for its Alzheimer's disease program. The company's lead candidate laromestrocel, a proprietary allogenic cellular therapy, has shown promising results in Phase 1 and 2 trials. The Phase 2a CLEAR MIND trial demonstrated significant improvements in clinical and biomarker endpoints compared to placebo, with results published in Nature Medicine in March 2025.
Following a Type B meeting with the FDA, Longeveron received alignment on a planned single, pivotal Phase 2/3 clinical trial, which could support a Biological License Application (BLA) if positive. The trial is expected to initiate in 2H 2026, subject to non-dilutive funding or partnership support. Notably, laromestrocel is reportedly the first cellular therapeutic to receive both FDA Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations for mild Alzheimer's disease.
Longeveron (NASDAQ: LGVN) ha annunciato la sua partecipazione alla BIO International Convention 2025 a Boston, dove la direzione esplorerà opportunità di partnership per il suo programma sulla malattia di Alzheimer. Il candidato principale dell'azienda, laromestrocel, una terapia cellulare allogenica proprietaria, ha mostrato risultati promettenti nelle fasi 1 e 2 degli studi clinici. Il trial CLEAR MIND di fase 2a ha evidenziato miglioramenti significativi negli endpoint clinici e nei biomarcatori rispetto al placebo, con i risultati pubblicati su Nature Medicine nel marzo 2025.
Dopo un incontro di tipo B con la FDA, Longeveron ha ottenuto un allineamento su uno studio clinico unico, fondamentale, di fase 2/3, che potrebbe supportare una domanda di licenza biologica (BLA) in caso di esito positivo. Lo studio è previsto per la seconda metà del 2026, subordinato a finanziamenti non diluitivi o supporto da partner. È importante sottolineare che laromestrocel sarebbe la prima terapia cellulare a ricevere le designazioni FDA Regenerative Medicine Advanced Therapy (RMAT) e Fast Track per la malattia di Alzheimer lieve.
Longeveron (NASDAQ: LGVN) anunció su participación en la Convención Internacional BIO 2025 en Boston, donde la dirección explorará oportunidades de asociación para su programa de enfermedad de Alzheimer. El candidato principal de la compañía, laromestrocel, una terapia celular alogénica patentada, ha mostrado resultados prometedores en los ensayos de Fase 1 y 2. El ensayo CLEAR MIND de fase 2a demostró mejoras significativas en los puntos finales clínicos y biomarcadores en comparación con el placebo, con resultados publicados en Nature Medicine en marzo de 2025.
Tras una reunión de Tipo B con la FDA, Longeveron recibió aprobación para un ensayo clínico único, fundamental, de fase 2/3, que podría respaldar una Solicitud de Licencia Biológica (BLA) si los resultados son positivos. El ensayo se espera que inicie en la segunda mitad de 2026, sujeto a financiamiento no dilutivo o apoyo de socios. Cabe destacar que laromestrocel sería la primera terapia celular en recibir las designaciones FDA Regenerative Medicine Advanced Therapy (RMAT) y Fast Track para la enfermedad de Alzheimer leve.
Longeveron (NASDAQ: LGVN)은 2025년 보스턴에서 열리는 BIO 국제 컨벤션에 참여한다고 발표했으며, 경영진은 알츠하이머병 프로그램을 위한 파트너십 기회를 모색할 예정입니다. 회사의 주요 후보물질인 laromestrocel은 독자적인 동종 세포 치료제로, 1상 및 2상 임상시험에서 유망한 결과를 보였습니다. 2a상 CLEAR MIND 시험은 위약 대비 임상 및 바이오마커 지표에서 유의미한 개선을 나타냈으며, 결과는 2025년 3월 Nature Medicine에 게재되었습니다.
FDA와의 Type B 미팅 후, Longeveron은 단일 중추적 2/3상 임상시험 계획에 대해 합의를 받았으며, 긍정적인 결과 시 생물학적 허가 신청서(BLA)를 지원할 수 있습니다. 이 시험은 비희석성 자금 지원 또는 파트너십 지원이 있을 경우 2026년 하반기에 시작될 예정입니다. 특히 laromestrocel은 경증 알츠하이머병에 대해 FDA 재생의학 첨단 치료(RMAT) 및 신속 심사(Fast Track) 지정을 모두 받은 최초의 세포 치료제로 알려져 있습니다.
Longeveron (NASDAQ : LGVN) a annoncé sa participation à la Convention Internationale BIO 2025 à Boston, où la direction explorera des opportunités de partenariat pour son programme sur la maladie d'Alzheimer. Le principal candidat de la société, laromestrocel, une thérapie cellulaire allogénique propriétaire, a montré des résultats prometteurs lors des essais de phases 1 et 2. L'essai CLEAR MIND de phase 2a a démontré des améliorations significatives sur les critères cliniques et les biomarqueurs par rapport au placebo, avec des résultats publiés dans Nature Medicine en mars 2025.
Suite à une réunion de type B avec la FDA, Longeveron a obtenu un accord sur un essai clinique unique pivotal de phase 2/3, qui pourrait soutenir une demande d'autorisation biologique (BLA) en cas de résultat positif. L'essai devrait débuter au second semestre 2026, sous réserve d'un financement non dilutif ou d'un soutien partenarial. Il est à noter que laromestrocel serait la première thérapie cellulaire à recevoir à la fois les désignations FDA Regenerative Medicine Advanced Therapy (RMAT) et Fast Track pour la maladie d'Alzheimer légère.
Longeveron (NASDAQ: LGVN) gab seine Teilnahme an der BIO International Convention 2025 in Boston bekannt, bei der das Management Partnerschaftsmöglichkeiten für sein Alzheimer-Programm erkunden wird. Der führende Kandidat des Unternehmens, laromestrocel, eine proprietäre allogene Zelltherapie, zeigte vielversprechende Ergebnisse in Phase-1- und Phase-2-Studien. Die Phase-2a CLEAR MIND-Studie zeigte signifikante Verbesserungen bei klinischen und Biomarker-Endpunkten im Vergleich zu Placebo, mit Ergebnissen, die im März 2025 in Nature Medicine veröffentlicht wurden.
Nach einem Type-B-Meeting mit der FDA erhielt Longeveron eine Einigung über eine geplante einzelne, wegweisende Phase-2/3-Studie, die bei positivem Ausgang eine Biologische Lizenzanwendung (BLA) unterstützen könnte. Die Studie soll in der zweiten Hälfte 2026 starten, vorbehaltlich nicht verwässernder Finanzierung oder Partnerschaftsunterstützung. Bemerkenswert ist, dass laromestrocel Berichten zufolge die erste zelluläre Therapie ist, die sowohl die FDA-Regenerative Medicine Advanced Therapy (RMAT)- als auch die Fast Track-Designation für leichte Alzheimer-Krankheit erhalten hat.
- Successful Phase 2a trial results showing disease progression slowdown
- FDA RMAT and Fast Track designations obtained for laromestrocel
- FDA alignment on pivotal Phase 2/3 trial that could lead to BLA submission
- Publication of trial results in prestigious Nature Medicine journal
- Phase 2/3 trial initiation dependent on securing non-dilutive funding or partnership
- Extended timeline with trial initiation not expected until 2H 2026
- Focus on potential partnership and strategic opportunities for the Company’s stem cell therapy program for Alzheimer’s disease
- Recent Type B meeting with FDA provided alignment on a planned single, pivotal Phase 2/3 clinical trial, which if positive, would be acceptable for Biological License Application (BLA) submission for Alzheimer’s disease
- Initiation of planned single, pivotal Phase 2/3 clinical trial in mild Alzheimer’s disease anticipated in 2H 2026, contingent upon obtaining non-dilutive funding and/or partnering support
- Results from the Phase 2a clinical trial (CLEAR MIND) evaluating laromestrocel as a potential treatment for Alzheimer’s disease were published in the peer reviewed journal Nature Medicine
- Laromestrocel is, to Company’s knowledge, the first cellular therapeutic candidate to receive FDA Regenerative Medicine Advanced Therapy (RMAT) designation for Alzheimer’s disease
MIAMI, May 20, 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 the Company will participate in the BIO International Convention taking place June 16-19, 2025 at the Boston Convention & Exhibition Center.
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 Alzheimer’s disease program, which has generated positive data in successful Phase 1 and Phase 2 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, were published in the peer reviewed journal Nature Medicine in March 2025.
Longeveron’s lead investigational therapeutic candidate is laromestrocel, a proprietary, scalable, allogenic cellular therapy. In the completed Phase 2a clinical trial (CLEAR MIND), 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.
Longeveron previously announced top-line results for the CLEAR MIND Phase 2a clinical trial on October 5, 2023, and reported additional clinical data and imaging biomarker results from CLEAR MIND on December 20, 2023. Full results from the CLEAR MIND study were presented in a featured research oral presentation at the 2024 Alzheimer's Association International Conference (AAIC).
The FDA has granted laromestrocel both Regenerative Medicine Advanced Therapy (RMAT) designation and Fast Track designation for the treatment of mild Alzheimer’s disease, which allow greater access to FDA interaction during laromestrocel’s development for Alzheimer’s disease. Laromestrocel is, to Company’s knowledge, the first cellular therapeutic candidate to receive FDA RMAT designation for Alzheimer’s disease.
To connect with Longeveron during the conference, please request a meeting via the BIO International Conference meeting portal or contact info@longeveron.com.
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 laromestorcel, 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 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
FAQ
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