[424B7] Plug Power Inc. Prospectus Filed Pursuant to Rule 424(b)(7)
On July 8, 2025, Longeveron Inc. (Nasdaq: LGVN) filed a Form 8-K announcing a U.S. FDA clearance of its Investigational New Drug (IND) application for laromestrocel, an allogeneic mesenchymal stem cell therapy derived from young, healthy donor bone marrow. The clearance authorizes the Company to initiate a Phase 2 clinical trial in pediatric dilated cardiomyopathy (DCM), a life-threatening heart condition with limited treatment options. No start-date, enrollment targets, or financial terms were included in the filing. The event represents a key regulatory milestone that advances Longeveron’s lead asset into mid-stage development and broadens its clinical program into the pediatric arena. Aside from the attached press release (Exhibit 99.1), the 8-K contains no additional financial statements, earnings data, or transactional disclosures.
Il 8 luglio 2025, Longeveron Inc. (Nasdaq: LGVN) ha presentato un modulo 8-K annunciando l'approvazione da parte della FDA statunitense della sua domanda di Nuovo Farmaco Sperimentale (IND) per laromestrocel, una terapia con cellule staminali mesenchimali allogeniche derivata dal midollo osseo di donatori giovani e sani. L'approvazione autorizza la Società ad avviare una fase 2 di sperimentazione clinica sulla cardiomiopatia dilatativa pediatrica (DCM), una condizione cardiaca potenzialmente letale con opzioni terapeutiche limitate. Nel documento non sono state specificate date di inizio, obiettivi di reclutamento o termini finanziari. Questo evento rappresenta un importante traguardo regolatorio che porta l'asset principale di Longeveron a uno sviluppo intermedio e amplia il programma clinico nel settore pediatrico. Oltre al comunicato stampa allegato (Esibizione 99.1), il modulo 8-K non contiene ulteriori bilanci finanziari, dati sugli utili o informazioni su transazioni.
El 8 de julio de 2025, Longeveron Inc. (Nasdaq: LGVN) presentó un Formulario 8-K anunciando la aprobación por parte de la FDA de EE. UU. de su solicitud de Nuevo Fármaco en Investigación (IND) para laromestrocel, una terapia con células madre mesenquimales alogénicas derivadas de médula ósea de donantes jóvenes y saludables. La aprobación autoriza a la Compañía a iniciar un ensayo clínico de fase 2 en miocardiopatía dilatada pediátrica (DCM), una condición cardíaca potencialmente mortal con opciones de tratamiento limitadas. No se incluyeron fechas de inicio, objetivos de reclutamiento ni términos financieros en la presentación. Este evento representa un hito regulatorio clave que impulsa el principal activo de Longeveron hacia un desarrollo en etapa media y amplía su programa clínico al ámbito pediátrico. Además del comunicado de prensa adjunto (Exhibición 99.1), el 8-K no contiene estados financieros adicionales, datos de ganancias ni divulgaciones de transacciones.
2025� 7� 8�, Longeveron Inc. (나스�: LGVN)은 미국 FDA� 임상시험� 신약(IND) 신청 승인� 발표하는 8-K 서류� 제출했습니다. � IND� 젊고 건강� 기증자의 골수에서 유래� 동종 중간� 줄기세포 치료제인 라로메스트로셀� 관� 것입니다. 이번 승인은 회사가 소아 확장� 심근병증(DCM) 대� 2� 임상시험� 시작� � 있도� 허가합니�. DCM은 치료 옵션� 제한� 생명� 위협하는 심장 질환입니�. 제출 서류에는 시작�, 등록 목표, 재무 조건� 포함되지 않았습니�. 이번 사건은 Longeveron� 주력 자산� 중간 단계 개발� 진전시키� 소아 임상 프로그램� 확장하는 중요� 규제 이정표입니다. 첨부� 보도자료(증거� 99.1) 외에 8-K에는 추가 재무제표, 수익 데이� 또는 거래 공시가 포함되어 있지 않습니다.
Le 8 juillet 2025, Longeveron Inc. (Nasdaq : LGVN) a déposé un formulaire 8-K annonçant la validation par la FDA américaine de sa demande de médicament expérimental (IND) pour le laromestrocel, une thérapie par cellules souches mésenchymateuses allogéniques dérivée de la moelle osseuse de donneurs jeunes et en bonne santé. Cette validation autorise la société à lancer un essai clinique de phase 2 dans la cardiomyopathie dilatée pédiatrique (DCM), une maladie cardiaque potentiellement mortelle avec peu d’options thérapeutiques. Aucun calendrier de démarrage, objectif de recrutement ou conditions financières n’ont été précisés dans le dossier. Cet événement constitue une étape réglementaire clé qui fait progresser l’actif principal de Longeveron vers un développement de stade intermédiaire et élargit son programme clinique au domaine pédiatrique. En dehors du communiqué de presse joint (Exhibit 99.1), le 8-K ne contient aucune information financière supplémentaire, donnée sur les bénéfices ou divulgation transactionnelle.
Am 8. Juli 2025 reichte Longeveron Inc. (Nasdaq: LGVN) ein Formular 8-K ein, in dem die FDA-Zulassung seines Antrags auf ein Investigational New Drug (IND) für Laromestrocel, eine allogene mesenchymale Stammzelltherapie, die aus dem Knochenmark junger, gesunder Spender stammt, bekannt gegeben wurde. Die Zulassung erlaubt es dem Unternehmen, eine Phase-2-Studie bei pädiatrischer dilatativer Kardiomyopathie (DCM) zu starten, eine lebensbedrohliche Herzerkrankung mit begrenzten Behandlungsmöglichkeiten. Im Antrag wurden kein Startdatum, keine Einschreibungsziele oder finanzielle Bedingungen genannt. Dieses Ereignis stellt einen wichtigen regulatorischen Meilenstein dar, der das führende Produkt von Longeveron in die mittlere Entwicklungsphase bringt und das klinische Programm auf den pädiatrischen Bereich ausweitet. Abgesehen von der beigefügten Pressemitteilung (Anlage 99.1) enthält das 8-K keine zusätzlichen Finanzberichte, Gewinnzahlen oder Transaktionsangaben.
- FDA clearance of IND enables initiation of Phase 2 trial for laromestrocel in pediatric DCM, marking a significant pipeline advancement.
- No financial guidance or trial parameters were provided, limiting investors� ability to assess cost, timeline, and near-term dilution risk.
Insights
TL;DR: FDA IND clearance lets LGVN advance laromestrocel into Phase 2 for pediatric DCM—a positive pipeline catalyst, but still early-stage.
The FDA’s go-ahead removes a major regulatory gate, validating pre-clinical data and manufacturing readiness for laromestrocel. Moving into Phase 2 increases asset value because pediatric DCM is an orphan indication with high unmet need, potentially enabling expedited paths such as Rare Pediatric Disease designation. However, the filing lacks trial design details or cash runway information, so investors cannot gauge budget impact or timeline. Overall, this milestone should be viewed as incrementally positive for sentiment and option value of LGVN’s stem-cell platform.
TL;DR: Regulatory milestone raises LGVN’s strategic optionality; financial materiality limited until efficacy data emerge.
From a portfolio perspective, the IND clearance is noteworthy because it de-risks regulatory risk for laromestrocel and positions LGVN for potential partnership discussions. Yet, without disclosed cost estimates or funding plans, the news does not immediately change cash-flow projections. Risk-adjusted valuation moves modestly higher, but the investment case still hinges on forthcoming Phase 2 data quality and capital strategy. I categorize the development as impactful but not transformative at this stage.
Il 8 luglio 2025, Longeveron Inc. (Nasdaq: LGVN) ha presentato un modulo 8-K annunciando l'approvazione da parte della FDA statunitense della sua domanda di Nuovo Farmaco Sperimentale (IND) per laromestrocel, una terapia con cellule staminali mesenchimali allogeniche derivata dal midollo osseo di donatori giovani e sani. L'approvazione autorizza la Società ad avviare una fase 2 di sperimentazione clinica sulla cardiomiopatia dilatativa pediatrica (DCM), una condizione cardiaca potenzialmente letale con opzioni terapeutiche limitate. Nel documento non sono state specificate date di inizio, obiettivi di reclutamento o termini finanziari. Questo evento rappresenta un importante traguardo regolatorio che porta l'asset principale di Longeveron a uno sviluppo intermedio e amplia il programma clinico nel settore pediatrico. Oltre al comunicato stampa allegato (Esibizione 99.1), il modulo 8-K non contiene ulteriori bilanci finanziari, dati sugli utili o informazioni su transazioni.
El 8 de julio de 2025, Longeveron Inc. (Nasdaq: LGVN) presentó un Formulario 8-K anunciando la aprobación por parte de la FDA de EE. UU. de su solicitud de Nuevo Fármaco en Investigación (IND) para laromestrocel, una terapia con células madre mesenquimales alogénicas derivadas de médula ósea de donantes jóvenes y saludables. La aprobación autoriza a la Compañía a iniciar un ensayo clínico de fase 2 en miocardiopatía dilatada pediátrica (DCM), una condición cardíaca potencialmente mortal con opciones de tratamiento limitadas. No se incluyeron fechas de inicio, objetivos de reclutamiento ni términos financieros en la presentación. Este evento representa un hito regulatorio clave que impulsa el principal activo de Longeveron hacia un desarrollo en etapa media y amplía su programa clínico al ámbito pediátrico. Además del comunicado de prensa adjunto (Exhibición 99.1), el 8-K no contiene estados financieros adicionales, datos de ganancias ni divulgaciones de transacciones.
2025� 7� 8�, Longeveron Inc. (나스�: LGVN)은 미국 FDA� 임상시험� 신약(IND) 신청 승인� 발표하는 8-K 서류� 제출했습니다. � IND� 젊고 건강� 기증자의 골수에서 유래� 동종 중간� 줄기세포 치료제인 라로메스트로셀� 관� 것입니다. 이번 승인은 회사가 소아 확장� 심근병증(DCM) 대� 2� 임상시험� 시작� � 있도� 허가합니�. DCM은 치료 옵션� 제한� 생명� 위협하는 심장 질환입니�. 제출 서류에는 시작�, 등록 목표, 재무 조건� 포함되지 않았습니�. 이번 사건은 Longeveron� 주력 자산� 중간 단계 개발� 진전시키� 소아 임상 프로그램� 확장하는 중요� 규제 이정표입니다. 첨부� 보도자료(증거� 99.1) 외에 8-K에는 추가 재무제표, 수익 데이� 또는 거래 공시가 포함되어 있지 않습니다.
Le 8 juillet 2025, Longeveron Inc. (Nasdaq : LGVN) a déposé un formulaire 8-K annonçant la validation par la FDA américaine de sa demande de médicament expérimental (IND) pour le laromestrocel, une thérapie par cellules souches mésenchymateuses allogéniques dérivée de la moelle osseuse de donneurs jeunes et en bonne santé. Cette validation autorise la société à lancer un essai clinique de phase 2 dans la cardiomyopathie dilatée pédiatrique (DCM), une maladie cardiaque potentiellement mortelle avec peu d’options thérapeutiques. Aucun calendrier de démarrage, objectif de recrutement ou conditions financières n’ont été précisés dans le dossier. Cet événement constitue une étape réglementaire clé qui fait progresser l’actif principal de Longeveron vers un développement de stade intermédiaire et élargit son programme clinique au domaine pédiatrique. En dehors du communiqué de presse joint (Exhibit 99.1), le 8-K ne contient aucune information financière supplémentaire, donnée sur les bénéfices ou divulgation transactionnelle.
Am 8. Juli 2025 reichte Longeveron Inc. (Nasdaq: LGVN) ein Formular 8-K ein, in dem die FDA-Zulassung seines Antrags auf ein Investigational New Drug (IND) für Laromestrocel, eine allogene mesenchymale Stammzelltherapie, die aus dem Knochenmark junger, gesunder Spender stammt, bekannt gegeben wurde. Die Zulassung erlaubt es dem Unternehmen, eine Phase-2-Studie bei pädiatrischer dilatativer Kardiomyopathie (DCM) zu starten, eine lebensbedrohliche Herzerkrankung mit begrenzten Behandlungsmöglichkeiten. Im Antrag wurden kein Startdatum, keine Einschreibungsziele oder finanzielle Bedingungen genannt. Dieses Ereignis stellt einen wichtigen regulatorischen Meilenstein dar, der das führende Produkt von Longeveron in die mittlere Entwicklungsphase bringt und das klinische Programm auf den pädiatrischen Bereich ausweitet. Abgesehen von der beigefügten Pressemitteilung (Anlage 99.1) enthält das 8-K keine zusätzlichen Finanzberichte, Gewinnzahlen oder Transaktionsangaben.
(To Prospectus dated May 27, 2025)
![[MISSING IMAGE: lg_plugtm-4c.jpg]](https://www.sec.gov/Archives/edgar/data/0001093691/000110465925066680/lg_plugtm-4c.jpg)
Offered by Selling Stockholder
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YA II PN, Ltd.
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125 Vista Boulevard
Slingerlands, New York, 12159
Attention: General Counsel
Telephone: (518) 782-7700
![[MISSING IMAGE: lg_plugtm-4c.jpg]](https://www.sec.gov/Archives/edgar/data/0001093691/000110465925066680/lg_plugtm-4c.jpg)
Preferred Stock
Warrants
Debt Securities
Units
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ABOUT THIS PROSPECTUS
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OUR COMPANY
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RISK FACTORS
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CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS
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USE OF PROCEEDS
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DESCRIPTION OF COMMON STOCK AND PREFERRED STOCK
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DESCRIPTION OF WARRANTS
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DESCRIPTION OF DEBT SECURITIES
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DESCRIPTION OF UNITS
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SELLING SECURITYHOLDERS
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PLAN OF DISTRIBUTION
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LEGAL MATTERS
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EXPERTS
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WHERE YOU CAN FIND ADDITIONAL INFORMATION
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INCORPORATION OF CERTAIN INFORMATION BY REFERENCE
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125 Vista Boulevard
Slingerlands, New York, 12159
Attention: General Counsel
Telephone: (518) 782-7700
![[MISSING IMAGE: lg_plugtm-4c.jpg]](https://www.sec.gov/Archives/edgar/data/0001093691/000110465925066680/lg_plugtm-4c.jpg)
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