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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 la 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'autorizzazione consente all'azienda di avviare una fase 2 di sperimentazione clinica nella cardiomiopatia dilatativa pediatrica (DCM), una patologia cardiaca grave con poche opzioni terapeutiche. Nel documento non sono state indicate date di inizio, obiettivi di reclutamento o termini finanziari. Questo evento rappresenta una tappa regolatoria fondamentale che porta l'asset principale di Longeveron allo sviluppo di medio stadio e amplia il programma clinico al 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 enfermedad 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 el 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 transaccionales.

2025년 7월 8일, Longeveron Inc. (나스닥: LGVN)은 미국 FDA로부터 자사의 신약 임상시험계획(IND) 승인을 알리는 Form 8-K를 제출했습니다. 이 승인으로 젊고 건강한 기증자의 골수에서 유래한 동종 중간엽 줄기세포 치료제인 라로메스트로셀에 대해 소아 확장성 심근병증(DCM) 대상 2상 임상시험을 시작할 수 있게 되었습니다. 제출서류에는 시작일, 모집 목표, 재무 조건이 포함되지 않았습니다. 이 사건은 Longeveron의 주력 자산을 중간 단계 개발로 진전시키고 임상 프로그램을 소아 영역으로 확장하는 중요한 규제 이정표입니다. 첨부된 보도자료(증거물 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 la validation par la FDA américaine de sa demande de nouveau médicament expérimental (IND) pour laromestrocel, une thérapie par cellules souches mésenchymateuses allogéniques dérivée de 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 grave avec peu d'options thérapeutiques. Aucune date de début, objectif d'inclusion ou conditions financières n'ont été précisées dans le dépôt. Cet événement marque une étape réglementaire clé qui fait progresser le principal produit de Longeveron vers un développement de stade intermédiaire et étend son programme clinique au domaine pédiatrique. Hormis le communiqué de presse joint (Exhibit 99.1), le 8-K ne contient aucune information financière supplémentaire, donnée sur les résultats ou divulgation transactionnelle.

Am 8. Juli 2025 reichte Longeveron Inc. (Nasdaq: LGVN) ein Formular 8-K ein, in dem die FDA-Freigabe seines Antrags auf Zulassung eines Prüfpräparats (IND) für Laromestrocel bekannt gegeben wurde, eine allogene mesenchymale Stammzelltherapie, die aus dem Knochenmark junger, gesunder Spender gewonnen wird. Die Freigabe erlaubt dem Unternehmen, eine Phase-2-Studie bei pädiatrischer dilatativer Kardiomyopathie (DCM) zu starten, einer lebensbedrohlichen Herzerkrankung mit begrenzten Behandlungsmöglichkeiten. Im Antrag wurden kein Startdatum, Einschreibungsziele oder finanzielle Bedingungen genannt. Dieses Ereignis stellt einen wichtigen regulatorischen Meilenstein dar, der Longeverons führendes Produkt in die mittlere Entwicklungsphase bringt und das klinische Programm auf den pädiatrischen Bereich ausweitet. Neben 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.

Il 8 luglio 2025, Longeveron Inc. (Nasdaq: LGVN) ha presentato un modulo 8-K annunciando la 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'autorizzazione consente all'azienda di avviare una fase 2 di sperimentazione clinica nella cardiomiopatia dilatativa pediatrica (DCM), una patologia cardiaca grave con poche opzioni terapeutiche. Nel documento non sono state indicate date di inizio, obiettivi di reclutamento o termini finanziari. Questo evento rappresenta una tappa regolatoria fondamentale che porta l'asset principale di Longeveron allo sviluppo di medio stadio e amplia il programma clinico al 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 enfermedad 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 el 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 transaccionales.

2025년 7월 8일, Longeveron Inc. (나스닥: LGVN)은 미국 FDA로부터 자사의 신약 임상시험계획(IND) 승인을 알리는 Form 8-K를 제출했습니다. 이 승인으로 젊고 건강한 기증자의 골수에서 유래한 동종 중간엽 줄기세포 치료제인 라로메스트로셀에 대해 소아 확장성 심근병증(DCM) 대상 2상 임상시험을 시작할 수 있게 되었습니다. 제출서류에는 시작일, 모집 목표, 재무 조건이 포함되지 않았습니다. 이 사건은 Longeveron의 주력 자산을 중간 단계 개발로 진전시키고 임상 프로그램을 소아 영역으로 확장하는 중요한 규제 이정표입니다. 첨부된 보도자료(증거물 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 la validation par la FDA américaine de sa demande de nouveau médicament expérimental (IND) pour laromestrocel, une thérapie par cellules souches mésenchymateuses allogéniques dérivée de 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 grave avec peu d'options thérapeutiques. Aucune date de début, objectif d'inclusion ou conditions financières n'ont été précisées dans le dépôt. Cet événement marque une étape réglementaire clé qui fait progresser le principal produit de Longeveron vers un développement de stade intermédiaire et étend son programme clinique au domaine pédiatrique. Hormis le communiqué de presse joint (Exhibit 99.1), le 8-K ne contient aucune information financière supplémentaire, donnée sur les résultats ou divulgation transactionnelle.

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

SEC Form 4
FORM 4 UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

STATEMENT OF CHANGES IN BENEFICIAL OWNERSHIP

Filed pursuant to Section 16(a) of the Securities Exchange Act of 1934
or Section 30(h) of the Investment Company Act of 1940
OMB APPROVAL
OMB Number: 3235-0287
Estimated average burden
hours per response: 0.5
Check this box if no longer subject to Section 16. Form 4 or Form 5 obligations may continue. See Instruction 1(b).
Check this box to indicate that a transaction was made pursuant to a contract, instruction or written plan for the purchase or sale of equity securities of the issuer that is intended to satisfy the affirmative defense conditions of Rule 10b5-1(c). See Instruction 10.
1. Name and Address of Reporting Person*
McGrane Michael Patrick

(Last) (First) (Middle)
C/O CF INDUSTRIES HOLDINGS, INC.
2375 WATERVIEW DRIVE

(Street)
NORTHBROOK IL 60062

(City) (State) (Zip)
2. Issuer Name and Ticker or Trading Symbol
CF Industries Holdings, Inc. [ CF ]
5. Relationship of Reporting Person(s) to Issuer
(Check all applicable)
Director 10% Owner
X Officer (give title below) Other (specify below)
VP, Gen. Counsel & Secretary
3. Date of Earliest Transaction (Month/Day/Year)
07/07/2025
4. If Amendment, Date of Original Filed (Month/Day/Year)
6. Individual or Joint/Group Filing (Check Applicable Line)
X Form filed by One Reporting Person
Form filed by More than One Reporting Person
Table I - Non-Derivative Securities Acquired, Disposed of, or Beneficially Owned
1. Title of Security (Instr. 3) 2. Transaction Date (Month/Day/Year) 2A. Deemed Execution Date, if any (Month/Day/Year) 3. Transaction Code (Instr. 8) 4. Securities Acquired (A) or Disposed Of (D) (Instr. 3, 4 and 5) 5. Amount of Securities Beneficially Owned Following Reported Transaction(s) (Instr. 3 and 4) 6. Ownership Form: Direct (D) or Indirect (I) (Instr. 4) 7. Nature of Indirect Beneficial Ownership (Instr. 4)
Code V Amount (A) or (D) Price
Common stock, par value $0.01 per share 07/07/2025 F 1,553 D $95.19 20,038 D
Table II - Derivative Securities Acquired, Disposed of, or Beneficially Owned
(e.g., puts, calls, warrants, options, convertible securities)
1. Title of Derivative Security (Instr. 3) 2. Conversion or Exercise Price of Derivative Security 3. Transaction Date (Month/Day/Year) 3A. Deemed Execution Date, if any (Month/Day/Year) 4. Transaction Code (Instr. 8) 5. Number of Derivative Securities Acquired (A) or Disposed of (D) (Instr. 3, 4 and 5) 6. Date Exercisable and Expiration Date (Month/Day/Year) 7. Title and Amount of Securities Underlying Derivative Security (Instr. 3 and 4) 8. Price of Derivative Security (Instr. 5) 9. Number of derivative Securities Beneficially Owned Following Reported Transaction(s) (Instr. 4) 10. Ownership Form: Direct (D) or Indirect (I) (Instr. 4) 11. Nature of Indirect Beneficial Ownership (Instr. 4)
Code V (A) (D) Date Exercisable Expiration Date Title Amount or Number of Shares
Explanation of Responses:
/s/ Michael P. McGrane 07/09/2025
** Signature of Reporting Person Date
Reminder: Report on a separate line for each class of securities beneficially owned directly or indirectly.
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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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