Mesoblast and FDA Align on Key Items for Revascor庐 Biologic License Application in Ischemic Heart Failure
Mesoblast (NASDAQ:MESO) has announced a significant regulatory advancement for its Revascor庐 (rexlemestrocel-L) treatment. The company has achieved alignment with the FDA on key requirements for filing a Biologics License Application (BLA) for treating patients with ischemic heart failure with reduced ejection fraction (HFrEF) and inflammation.
Following a successful Type B meeting under the existing Regenerative Medicine Advanced Therapy (RMAT) designation, where the FDA indicated that presented studies could support accelerated approval, Mesoblast met with the FDA on June 3, 2025. The FDA's formal minutes confirmed alignment on critical aspects including chemistry, manufacturing & controls (CMC), potency assays for commercial product release, and the proposed design and primary endpoint for the post-approval confirmatory trial.
The company plans to file for accelerated approval by the end of 2025, specifically targeting patients with end-stage ischemic HFrEF who have been implanted with a left ventricular assist device (LVAD).
Mesoblast (NASDAQ:MESO) ha annunciato un importante progresso regolatorio per il suo trattamento Revascor庐 (rexlemestrocel-L). L'azienda ha raggiunto un accordo con la FDA sui requisiti chiave per la presentazione di una domanda di licenza biologica (BLA) per il trattamento di pazienti con insufficienza cardiaca ischemica a frazione di eiezione ridotta (HFrEF) e infiammazione.
Dopo un incontro di tipo B di successo nell'ambito della designazione esistente di Terapia Avanzata di Medicina Rigenerativa (RMAT), durante il quale la FDA ha indicato che gli studi presentati potrebbero supportare un'approvazione accelerata, Mesoblast ha incontrato la FDA il 3 giugno 2025. I verbali ufficiali della FDA hanno confermato l'allineamento su aspetti critici quali chimica, produzione e controlli (CMC), test di potenza per il rilascio commerciale del prodotto e il disegno proposto con l'endpoint primario per lo studio confermativo post-approvazione.
L'azienda intende presentare la domanda per l'approvazione accelerata entro la fine del 2025, mirando specificamente ai pazienti con HFrEF ischemica in stadio terminale che hanno ricevuto un dispositivo di assistenza ventricolare sinistra (LVAD).
Mesoblast (NASDAQ:MESO) ha anunciado un avance regulatorio significativo para su tratamiento Revascor庐 (rexlemestrocel-L). La compa帽铆a ha alcanzado un acuerdo con la FDA sobre los requisitos clave para presentar una Solicitud de Licencia Biol贸gica (BLA) para tratar a pacientes con insuficiencia card铆aca isqu茅mica con fracci贸n de eyecci贸n reducida (HFrEF) e inflamaci贸n.
Tras una exitosa reuni贸n tipo B bajo la designaci贸n existente de Terapia Avanzada de Medicina Regenerativa (RMAT), donde la FDA indic贸 que los estudios presentados podr铆an respaldar una aprobaci贸n acelerada, Mesoblast se reuni贸 con la FDA el 3 de junio de 2025. Las actas formales de la FDA confirmaron el acuerdo en aspectos cr铆ticos como qu铆mica, fabricaci贸n y controles (CMC), ensayos de potencia para la liberaci贸n comercial del producto y el dise帽o propuesto con el endpoint primario para el ensayo confirmatorio post-aprobaci贸n.
La compa帽铆a planea presentar la solicitud para la aprobaci贸n acelerada antes de finales de 2025, enfoc谩ndose espec铆ficamente en pacientes con HFrEF isqu茅mica en etapa terminal que han sido implantados con un dispositivo de asistencia ventricular izquierda (LVAD).
Mesoblast (NASDAQ:MESO)電� Revascor庐(rexlemestrocel-L) 旃橂鞝滌棎 雽�頃� 欷戩殧頃� 攴滌牅 歆勳爠鞚� 氚滍憸頄堨姷雼堧嫟. 须岇偓电� 項堩槇靹� 鞁秬鞝� 臧愳唽霅� 氚曥稖毳�(HFrEF) 氚� 鞐检 頇橃瀽 旃橂毳� 鞙勴暅 靸濍頃欖爜 霛检澊靹犾姢 鞁犾箔靹�(BLA) 鞝滌稖鞐� 雽�頃� FDA鞕� 欤检殧 鞖旉惮靷暛鞐� 頃╈潣毳� 鞚措（鞐堨姷雼堧嫟.
旮办〈 鞛儩 鞚橅暀 觳嫧 旃橂(RMAT) 歆�鞝� 頃橃棎 靹标车鞝侅澑 鞙犿槙 B 須岇潣 頉�, FDA電� 鞝滌稖霅� 鞐瓣惮臧� 臧�靻� 鞀轨澑 歆�鞗愳澊 臧�電ロ晿雼り碃 氚濏様鞙茧┌, Mesoblast電� 2025雲� 6鞗� 3鞚� FDA鞕� 須岇潣毳� 臧�臁岇姷雼堧嫟. FDA鞚� 瓿奠嫕 須岇潣搿濎潃 頇旐暀, 鞝滌“ 氚� 甏�毽�(CMC), 靸侅梾鞖� 鞝滍拡 於滍晿毳� 鞙勴暅 須姤 鞁滍棙, 鞀轨澑 頉� 頇曥澑 鞁滍棙鞚� 靹り硠 氚� 欤检殧 韽夑皜氤�靾橃棎 雽�頃� 頃╈潣臧� 鞚措（鞏挫鞚岇潉 頇曥澑頄堨姷雼堧嫟.
须岇偓电� 2025雲� 毵愱箤歆� 臧�靻� 鞀轨澑 鞁犾箔鞚� 瓿勴殟頃橁碃 鞛堨溂氅�, 韸鬼瀳 膦岇嫭鞁� 氤挫“ 鞛レ箻(LVAD)毳� 鞚挫嫕氚涭潃 毵愱赴 項堩槇靹� HFrEF 頇橃瀽毳� 雽�靸侅溂搿� 頃橁碃 鞛堨姷雼堧嫟.
Mesoblast (NASDAQ:MESO) a annonc茅 une avanc茅e r茅glementaire majeure pour son traitement Revascor庐 (rexlemestrocel-L). La soci茅t茅 a obtenu un alignement avec la FDA sur les exigences cl茅s pour le d茅p么t d'une demande d'autorisation de mise sur le march茅 biologique (BLA) visant 脿 traiter les patients souffrant d'insuffisance cardiaque isch茅mique avec fraction d'茅jection r茅duite (HFrEF) et inflammation.
Suite 脿 une r茅union de type B r茅ussie dans le cadre de la d茅signation existante de th茅rapie avanc茅e en m茅decine r茅g茅n茅rative (RMAT), o霉 la FDA a indiqu茅 que les 茅tudes pr茅sent茅es pourraient soutenir une approbation acc茅l茅r茅e, Mesoblast a rencontr茅 la FDA le 3 juin 2025. Le proc猫s-verbal officiel de la FDA a confirm茅 l'alignement sur des aspects critiques tels que la chimie, la fabrication et le contr么le (CMC), les tests de puissance pour la lib茅ration commerciale du produit, ainsi que la conception propos茅e et le crit猫re d'茅valuation principal de l'essai confirmatoire post-approbation.
La soci茅t茅 pr茅voyait de d茅poser une demande d'approbation acc茅l茅r茅e d'ici la fin 2025, ciblant sp茅cifiquement les patients atteints d'HFrEF isch茅mique en phase terminale ayant re莽u un dispositif d'assistance ventriculaire gauche (LVAD).
Mesoblast (NASDAQ:MESO) hat einen bedeutenden regulatorischen Fortschritt f眉r seine Behandlung Revascor庐 (rexlemestrocel-L) bekannt gegeben. Das Unternehmen hat eine 脺bereinstimmung mit der FDA zu den wichtigsten Anforderungen f眉r die Einreichung eines Biologics License Application (BLA) zur Behandlung von Patienten mit isch盲mischer Herzinsuffizienz mit reduzierter Ejektionsfraktion (HFrEF) und Entz眉ndung erzielt.
Nach einem erfolgreichen Type-B-Meeting im Rahmen der bestehenden Regenerative Medicine Advanced Therapy (RMAT)-Zulassung, bei dem die FDA angab, dass die vorgelegten Studien eine beschleunigte Zulassung unterst眉tzen k枚nnten, traf sich Mesoblast am 3. Juni 2025 mit der FDA. Die offiziellen Protokolle der FDA best盲tigten die 脺bereinstimmung in kritischen Punkten wie Chemie, Herstellung & Kontrolle (CMC), Wirksamkeitspr眉fungen f眉r die kommerzielle Produktfreigabe sowie das vorgeschlagene Design und den prim盲ren Endpunkt der nachgelagerten Best盲tigungsstudie.
Das Unternehmen plant, bis Ende 2025 einen Antrag auf beschleunigte Zulassung einzureichen, mit dem Schwerpunkt auf Patienten mit terminaler isch盲mischer HFrEF, die mit einem linken Ventrikelunterst眉tzungsger盲t (LVAD) versorgt wurden.
- FDA alignment achieved on key BLA filing requirements for Revascor庐
- Existing RMAT designation supports potential accelerated approval pathway
- FDA confirmed previous studies could support accelerated approval
- Clear regulatory pathway established with planned BLA filing by end of 2025
- None.
NEW YORK, June 30, 2025 (GLOBE NEWSWIRE) -- Mesoblast (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced alignment with the United States Food and Drug Administration (FDA) on items required for filing a Biologics License Application (BLA) for Revascor庐 (rexlemestrocel-L) in the treatment of patients with ischemic heart failure with reduced ejection fraction (HFrEF) and inflammation.
In follow-up to the successful Type B meeting in early 2024 under the existing Regenerative Medicine Advanced Therapy (RMAT) designation for REVASCOR in end-stage HFrEF patients with a left ventricular assist device (LVAD), where FDA stated that the results of the presented studies could support accelerated approval, Mesoblast met with FDA on June 3, 2025 to align on key items for BLA filing. FDA provided formal minutes to the company following the most recent Type B meeting. The minutes confirm alignment with FDA on items regarding chemistry, manufacturing & controls (CMC), potency assays for commercial product release, and proposed design and primary endpoint for the confirmatory trial post-approval.
Mesoblast intends to file by the end of the year for accelerated approval in patients with end-stage ischemic HFrEF implanted with an LVAD.
About Mesoblast
Mesoblast (the Company) is a world leader in developing allogeneic (off-the-shelf) cellular medicines for the treatment of severe and life-threatening inflammatory conditions. The therapies from the Company鈥檚 proprietary mesenchymal lineage cell therapy technology platform respond to severe inflammation by releasing anti-inflammatory factors that counter and modulate multiple effector arms of the immune system, resulting in significant reduction of the damaging inflammatory process.
Mesoblast鈥檚 RYONCIL庐 (remestemcel-L) for the treatment of steroid-refractory acute graft versus host disease (SR-aGvHD) in pediatric patients 2 months and older is the first FDA mesenchymal stromal cell (MSC) therapy. Please see the full Prescribing Information at .
Mesoblast is committed to developing additional cell therapies for distinct indications based on its remestemcel-L and rexlemestrocel-L allogeneic stromal cell technology platforms. RYONCIL is being developed for additional inflammatory diseases including SR-aGvHD in adults and biologic-resistant inflammatory bowel disease. Rexlemestrocel-L is being developed for heart failure and chronic low back pain. The Company has established commercial partnerships in Japan, Europe and China.
About Mesoblast intellectual property: Mesoblast has a strong and extensive global intellectual property portfolio, with over 1,000 granted patents or patent applications covering mesenchymal stromal cell compositions of matter, methods of manufacturing and indications. These granted patents and patent applications are expected to provide commercial protection extending through to at least 2041 in major markets.
About Mesoblast manufacturing: The Company鈥檚 proprietary manufacturing processes yield industrial-scale, cryopreserved, off-the-shelf, cellular medicines. These cell therapies, with defined pharmaceutical release criteria, are planned to be readily available to patients worldwide.
Mesoblast has locations in Australia, the United States and Singapore and is listed on the Australian Securities Exchange (MSB) and on the Nasdaq (MESO). For more information, please see , LinkedIn: Mesoblast Limited and X: @Mesoblast
Forward-Looking Statements
This press release includes forward-looking statements that relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Forward-looking statements should not be read as a guarantee of future performance or results, and actual results may differ from the results anticipated in these forward-looking statements, and the differences may be material and adverse. Forward-looking statements include, but are not limited to, statements about: the initiation, timing, progress and results of Mesoblast鈥檚 preclinical and clinical studies, and Mesoblast鈥檚 research and development programs; Mesoblast鈥檚 ability to advance product candidates into, enroll and successfully complete, clinical studies, including multi-national clinical trials; Mesoblast鈥檚 ability to advance its manufacturing capabilities; the timing or likelihood of regulatory filings and approvals, manufacturing activities and product marketing activities, if any; the commercialization of Mesoblast鈥檚 RYONCIL for pediatric SR-aGVHD and any other product candidates, if approved; regulatory or public perceptions and market acceptance surrounding the use of stem-cell based therapies; the potential for Mesoblast鈥檚 product candidates, if any are approved, to be withdrawn from the market due to patient adverse events or deaths; the potential benefits of strategic collaboration agreements and Mesoblast鈥檚 ability to enter into and maintain established strategic collaborations; Mesoblast鈥檚 ability to establish and maintain intellectual property on its product candidates and Mesoblast鈥檚 ability to successfully defend these in cases of alleged infringement; the scope of protection Mesoblast is able to establish and maintain for intellectual property rights covering its product candidates and technology; estimates of Mesoblast鈥檚 expenses, future revenues, capital requirements and its needs for additional financing; Mesoblast鈥檚 financial performance; developments relating to Mesoblast鈥檚 competitors and industry; and the pricing and reimbursement of Mesoblast鈥檚 product candidates, if approved. You should read this press release together with our risk factors, in our most recently filed reports with the SEC or on our website. Uncertainties and risks that may cause Mesoblast鈥檚 actual results, performance or achievements to be materially different from those which may be expressed or implied by such statements, and accordingly, you should not place undue reliance on these forward-looking statements. We do not undertake any obligations to publicly update or revise any forward-looking statements, whether as a result of new information, future developments or otherwise.
Release authorized by the Chief Executive.
For more information, please contact:
| Corporate Communications / Investors | 听 |
| Paul Hughes | 听 |
| T: +61 3 9639 6036 | 听 |
| 听 | 听 |
| Media 鈥� Global | 听 |
| Allison Worldwide | 听 |
| Emma Neal | 听 |
| T: +1 603 545 4843 | 听 |
| E: [email protected] | 听 |
| 听 | 听 |
| Media 鈥� Australia | 听 |
| BlueDot Media | 听 |
| Steve Dabkowski | 听 |
| T: +61 419 880 486 | 听 |
| E: [email protected] | 听 |
FAQ
What is the status of Mesoblast's (MESO) Revascor庐 FDA approval process?
What indication is Mesoblast (MESO) seeking approval for with Revascor庐?
What regulatory designations does Mesoblast's Revascor庐 currently have?
When does Mesoblast (MESO) plan to submit the BLA for Revascor庐?
What key agreements were reached between Mesoblast and the FDA for Revascor庐?
