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[8-K] Longeveron Inc. Reports Material Event

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(Neutral)
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(Neutral)
Form Type
8-K
Rhea-AI Filing Summary

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.

L'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 a iniziare 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 indicate date di inizio, obiettivi di arruolamento o termini finanziari. Questo evento rappresenta una tappa regolatoria fondamentale che porta l'asset principale di Longeveron a uno stadio di sviluppo intermedio e amplia il programma clinico nel campo 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 la FDA de EE. UU. de su solicitud de Nuevo Medicamento 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 avanza el principal activo de Longeveron hacia un desarrollo en etapa media y amplía su programa clínico en el ámbito pediátrico. Aparte del comunicado de prensa adjunto (Exhibición 99.1), el 8-K no contiene estados financieros adicionales, datos de ganancias ni divulgaciones transaccionales.

2025년 7월 8일, Longeveron Inc. (나스닥: LGVN)은 미국 FDA의 임상시험용 신약(IND) 신청 승인을 발표하는 Form 8-K를 제출했습니다. 이 승인으로 인해 젊고 건강한 공여자의 골수에서 유래한 동종 중간엽 줄기세포 치료제인 라로메스트로셀에 대해 소아 확장성 심근병증(DCM) 대상 2상 임상시험을 시작할 수 있게 되었습니다. 이 심각한 심장 질환은 치료 옵션이 제한적입니다. 제출 서류에는 시작일, 등록 목표 또는 재무 조건이 포함되지 않았습니다. 이번 승인은 Longeveron의 주력 자산을 중간 단계 개발로 진전시키고 소아 분야로 임상 프로그램을 확장하는 중요한 규제 이정표입니다. 첨부된 보도자료(전시물 99.1) 외에 8-K에는 추가 재무제표, 수익 데이터 또는 거래 공시가 포함되어 있지 않습니다.

Le 8 juillet 2025, Longeveron Inc. (Nasdaq : LGVN) a déposé un formulaire 8-K annonçant l’autorisation de la FDA américaine de sa demande de nouveau médicament expérimental (IND) pour le laromestrocel, une thérapie par cellules souches mésenchymateuses allogéniques dérivées de moelle osseuse de donneurs jeunes et en bonne santé. Cette autorisation permet à la société de lancer un essai clinique de phase 2 dans la cardiomyopathie dilatée pédiatrique (DCM), une maladie cardiaque grave avec peu d’options thérapeutiques. Aucun calendrier de démarrage, objectif d’inclusion ou termes financiers n’ont été précisés dans le dépôt. Cet événement constitue une étape réglementaire clé qui fait progresser le principal produit de Longeveron vers un développement de stade intermédiaire et élargit son programme clinique au domaine pédiatrique. Hormis le communiqué de presse joint (Exhibit 99.1), le formulaire 8-K ne contient aucun autre état financier, donnée de résultats ou divulgation transactionnelle.

Am 8. Juli 2025 reichte Longeveron Inc. (Nasdaq: LGVN) ein Formular 8-K ein, in dem die FDA-Freigabe ihres Antrags auf ein Prüfpräparat (IND) für Laromestrocel bekannt gegeben wurde, eine allogene mesenchymale Stammzelltherapie, die aus dem Knochenmark junger, gesunder Spender gewonnen wird. Die Freigabe erlaubt dem Unternehmen den Beginn einer Phase-2-Studie bei pädiatrischer dilatativer Kardiomyopathie (DCM), einer lebensbedrohlichen Herzerkrankung mit begrenzten Behandlungsmöglichkeiten. Im Antrag wurden kein Startdatum, keine Einschreibungsziele oder finanzielle Bedingungen genannt. Dieses Ereignis stellt einen wichtigen regulatorischen Meilenstein dar, der Longeverons Hauptwirkstoff in die mittlere Entwicklungsphase bringt und das klinische Programm auf den pädiatrischen Bereich erweitert. Abgesehen von der beigefügten Pressemitteilung (Anlage 99.1) enthält das 8-K keine zusätzlichen Finanzberichte, Gewinnzahlen oder Transaktionsangaben.

Positive
  • FDA clearance of IND enables initiation of Phase 2 trial for laromestrocel in pediatric DCM, marking a significant pipeline advancement.
Negative
  • 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.

L'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 a iniziare 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 indicate date di inizio, obiettivi di arruolamento o termini finanziari. Questo evento rappresenta una tappa regolatoria fondamentale che porta l'asset principale di Longeveron a uno stadio di sviluppo intermedio e amplia il programma clinico nel campo 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 la FDA de EE. UU. de su solicitud de Nuevo Medicamento 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 avanza el principal activo de Longeveron hacia un desarrollo en etapa media y amplía su programa clínico en el ámbito pediátrico. Aparte del comunicado de prensa adjunto (Exhibición 99.1), el 8-K no contiene estados financieros adicionales, datos de ganancias ni divulgaciones transaccionales.

2025년 7월 8일, Longeveron Inc. (나스닥: LGVN)은 미국 FDA의 임상시험용 신약(IND) 신청 승인을 발표하는 Form 8-K를 제출했습니다. 이 승인으로 인해 젊고 건강한 공여자의 골수에서 유래한 동종 중간엽 줄기세포 치료제인 라로메스트로셀에 대해 소아 확장성 심근병증(DCM) 대상 2상 임상시험을 시작할 수 있게 되었습니다. 이 심각한 심장 질환은 치료 옵션이 제한적입니다. 제출 서류에는 시작일, 등록 목표 또는 재무 조건이 포함되지 않았습니다. 이번 승인은 Longeveron의 주력 자산을 중간 단계 개발로 진전시키고 소아 분야로 임상 프로그램을 확장하는 중요한 규제 이정표입니다. 첨부된 보도자료(전시물 99.1) 외에 8-K에는 추가 재무제표, 수익 데이터 또는 거래 공시가 포함되어 있지 않습니다.

Le 8 juillet 2025, Longeveron Inc. (Nasdaq : LGVN) a déposé un formulaire 8-K annonçant l’autorisation de la FDA américaine de sa demande de nouveau médicament expérimental (IND) pour le laromestrocel, une thérapie par cellules souches mésenchymateuses allogéniques dérivées de moelle osseuse de donneurs jeunes et en bonne santé. Cette autorisation permet à la société de lancer un essai clinique de phase 2 dans la cardiomyopathie dilatée pédiatrique (DCM), une maladie cardiaque grave avec peu d’options thérapeutiques. Aucun calendrier de démarrage, objectif d’inclusion ou termes financiers n’ont été précisés dans le dépôt. Cet événement constitue une étape réglementaire clé qui fait progresser le principal produit de Longeveron vers un développement de stade intermédiaire et élargit son programme clinique au domaine pédiatrique. Hormis le communiqué de presse joint (Exhibit 99.1), le formulaire 8-K ne contient aucun autre état financier, donnée de résultats ou divulgation transactionnelle.

Am 8. Juli 2025 reichte Longeveron Inc. (Nasdaq: LGVN) ein Formular 8-K ein, in dem die FDA-Freigabe ihres Antrags auf ein Prüfpräparat (IND) für Laromestrocel bekannt gegeben wurde, eine allogene mesenchymale Stammzelltherapie, die aus dem Knochenmark junger, gesunder Spender gewonnen wird. Die Freigabe erlaubt dem Unternehmen den Beginn einer Phase-2-Studie bei pädiatrischer dilatativer Kardiomyopathie (DCM), einer lebensbedrohlichen Herzerkrankung mit begrenzten Behandlungsmöglichkeiten. Im Antrag wurden kein Startdatum, keine Einschreibungsziele oder finanzielle Bedingungen genannt. Dieses Ereignis stellt einen wichtigen regulatorischen Meilenstein dar, der Longeverons Hauptwirkstoff in die mittlere Entwicklungsphase bringt und das klinische Programm auf den pädiatrischen Bereich erweitert. Abgesehen von der beigefügten Pressemitteilung (Anlage 99.1) enthält das 8-K keine zusätzlichen Finanzberichte, Gewinnzahlen oder Transaktionsangaben.

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of

the Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): July 8, 2025

 

Longeveron Inc.

(Exact name of registrant as specified in its charter)

 

Delaware   001-40060   47-2174146
(State or Other Jurisdiction
of Incorporation)
  (Commission File Number)   (IRS Employer
Identification No.)

 

1951 NW 7th Avenue, Suite 520

Miami, Florida 33136

(Address of Principal Executive Offices)

 

Registrant’s Telephone Number, Including Area Code: (305) 909-0840

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class   Trading Symbol(s)   Name of each exchange on which
registered
Class A Common Stock, $0.001 par value per share   LGVN   The Nasdaq Capital Market

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter)

 

Emerging Growth Company

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

 

 

 

 

 

Item 8.01. Other Events

 

On July 8, 2025, Longeveron Inc. (the “Company”) issued a press release announcing that the U.S. Food and Drug Administration has cleared the Investigational New Drug application (“IND”) to initiate a Phase 2 clinical trial for the Company’s lead investigational product laromestrocel, an allogeneic mesenchymal stem cell formulation sourced from the bone marrow of young, healthy adult donors, as a potential treatment for pediatric dilated cardiomyopathy (DCM). A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and incorporated by reference herein.

 

Item 9.01. Financial Statements and Exhibits.

 

(d) Exhibits.

 

The exhibits listed in the following Exhibit Index are filed as part of this Current Report on Form 8-K.

 

Exhibit No.   Description
99.1   Press Release issued by the Company on July 8, 2025
104   Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

1

 

 

SIGNATURE

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

  LONGEVERON INC.
   
Date: July 9, 2025 /s/ Wa’el Hashad
  Name:  Wa’el Hashad
  Title:  Chief Executive Officer

 

2

FAQ

What did Longeveron (LGVN) announce in its July 8 2025 8-K?

The company disclosed FDA clearance of its IND to start a Phase 2 trial of laromestrocel in pediatric dilated cardiomyopathy.

What is laromestrocel?

Laromestrocel is an allogeneic mesenchymal stem cell product sourced from bone marrow of young, healthy adult donors.

Which indication will the new Phase 2 trial target?

The trial will evaluate laromestrocel as a potential treatment for pediatric dilated cardiomyopathy (DCM).

Were any financial results or guidance included in the filing?

No; the 8-K did not contain earnings figures, budgets, or cash-runway information.

Is this milestone likely to impact LGVN’s near-term revenue?

Not immediately; the clearance only permits trial initiation and does not generate revenue until later clinical stages.
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