Mesoblast

Mesoblast Ltd. is a biopharmaceutical company, which engages in the research, development, and market of mesenchymal lineage adult stem cell technology platform. Its medicines target the cardiovascular diseases, spine orthopedic disorders, oncology and hematology, immune-mediated, and inflammatory diseases. The company was founded by Itescu Silviu on June 8, 2004 and is headquartered in Melbourne, Australia.

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Mesoblast Ltd. is a biopharmaceutical company, which engages in the research, development, and market of mesenchymal lineage adult stem cell technology platform. Its medicines target cardiovascular diseases, spine orthopedic disorders, oncology and hematology, immune-mediated, and inflammatory diseases. The company was founded by Silviu Itescu on June 8, 2004 and is headquartered in Melbourne, Australia.

The FDA approves Mesoblast's Ryoncil (remestemcel-L) for treating pediatric patients with steroid-refractory acute graft versus host disease. Shares rise.

MESO Stock Up as FDA Approves Ryoncil for Graft Versus Host Disease

On Wednesday, the FDA approved Mesoblast Limited's MESO Ryoncil (remestemcel-L) as the first mesenchymal stromal cell (MSC) therapy in the U.S.

Mesoblast's Cell Therapy Treatment For Graft Versus Host Disease Gets FDA Approval, Stock Surges

NEW YORK, Dec. 18, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced the Food and Drug Administration (FDA) approved Ryoncil® (remestemcel-L) as the first mesenchymal stromal cell (MSC) therapy in the United States. RYONCIL is the only MSC therapy approved in the U.S. for any indication, and the only approved therapy for steroid-refractory acute graft versus host disease (SR-aGvHD) in children 2 months and older, including adolescents and teenagers.

Mesoblast's RYONCIL® is the First U.S. FDA-Approved Mesenchymal Stromal Cell (MSC) Therapy

Mesoblast snagged FDA approval late Wednesday for the first-ever treatment for children with a form of GVHD. The biotech stock rocketed.

Top-Notch Biotech Mesoblast Skyrockets 29% On Immune Condition Approval

The U.S. Food and Drug Administration on Wednesday approved Mesoblast's cell therapy for treating a type of complication that occurs after a stem cell or bone marrow transplant called graft-versus-host disease.

US FDA approves Mesoblast's cell therapy for graft-versus-host disease

NEW YORK, Dec. 18, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced its upcoming addition to the Nasdaq Biotechnology Index (Nasdaq: NBI) as part of the annual reconstitution of the 2024 Nasdaq index. Mesoblast's inclusion in the NBI will be effective after the U.S. market opens on Monday, December 23, 2024.

Mesoblast to be Added to Nasdaq Biotechnology Index

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Earlier this year FDA granted REVASCOR both Rare Pediatric Disease Designation (RPDD) and Orphan-Drug Designation (ODD) for congenital heart disease Earlier this year FDA granted REVASCOR both Rare Pediatric Disease Designation (RPDD) and Orphan-Drug Designation (ODD) for congenital heart disease

FDA Grants Revascor® (Rexlemestrocel-L) Regenerative Medicine Advanced Therapy (RMAT) Designation in Children with Congenital Heart Disease

Phase 3 trial results published in European Journal of Heart Failure identify key target population for Mesoblast allogeneic cell therapy Phase 3 trial results published in European Journal of Heart Failure identify key target population for Mesoblast allogeneic cell therapy

Revascor Improves Survival and Reduces Major Morbidity in High-Risk Ischemic Heart Failure Patients With Inflammation

NEW YORK, Oct. 30, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided highlights of its recent activities for the first quarter ended September 30, 2024.

Appendix 4C Quarterly Activity Report for Quarter Ended September 30, 2024

Mesoblast Limited is advancing innovative cellular therapies, with Remestemcel-L for pediatric SR-aGVHD nearing FDA approval and a PDUFA date set for January 2025. Positive Phase 3 results indicate that Remestemcel-L significantly improves response rates and survival in pediatric patients. Additionally, Mesoblast's pipeline includes late-stage therapies for chronic low back pain and heart failure, both of which are showing promising results and are nearing regulatory approval.

Mesoblast: Undervalued Due To Remestemcel-L's Substantial Growth Potential

NEW YORK, Sept. 29, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced it has entered into a convertible note subscription agreement with its largest shareholder Gregory George (“Investor”) for issue, at its sole discretion, up to US$50.0 million (A$72.7 million) convertible notes on approval by the United States Food and Drug Administration (FDA) of Mesoblast's lead product candidate Ryoncil® (remestemcel-L) in the treatment of children with steroid-refractory acute graft versus host disease (SR-aGvHD). The funding is available at Mesoblast's option and will enable the Company to seamlessly implement its go-to-market commercial strategy. Mesoblast anticipates a decision prior to or on the FDA's Prescription Drug User Fee Act (PDUFA) goal date of January 7, 2025.

Mesoblast Option to Issue Up to US$50 Million Convertible Notes for Product Launch

Mesoblast Limited (NASDAQ:MESO ) Q4 2024 Earnings Conference Call August 28, 2024 6:30 PM ET Company Participants Silviu Itescu - Chief Executive Officer and Managing Director Andrew Chaponnel - Interim Chief Financial Officer Conference Call Participants Edward Tenthoff - Piper Sandler Operator Hello and welcome to the Mesoblast Financial Results for the Full Year ended June 30, 2024. An announcement and presentation have been lodged with the ASX and are available on the home and investor pages at www.

Mesoblast Limited (MESO) Q4 2024 Earnings Call Transcript

NEW YORK, Aug. 28, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided an operational update and reported financial results for the period ended June 30, 2024. Mesoblast Chief Executive Silviu Itescu said: “During the past year we have built significant momentum in our interactions with the United States Food and Drug Administration (FDA) across each of our Phase 3 products.

Mesoblast Reports Financial Results and Operational Update for Fiscal Year Ended June 30, 2024

NEW YORK, Aug. 27, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, will host a webcast to discuss operational highlights and financial results for the full year ended June 30, 2024.

Mesoblast Financial Results and Corporate Update Webcast

Ryoncil BLA Submission Under FDA Review for Approval in Children with SR-aGVHD Ryoncil BLA Submission Under FDA Review for Approval in Children with SR-aGVHD

Appendix 4C Quarterly Activity Report for Quarter Ended June 30, 2024

If Approved, RYONCIL will be the First Allogeneic “Off-the-Shelf” Cellular Medicine in the US, and the First Cell Therapy for Children Up To 18 Years Old with SR-aGVHD If Approved, RYONCIL will be the First Allogeneic “Off-the-Shelf” Cellular Medicine in the US, and the First Cell Therapy for Children Up To 18 Years Old with SR-aGVHD

FDA Accepts Mesoblast's Biologics License Application (BLA) for Ryoncil® in Children With Steroid-Refractory Acute Graft-Versus-Host Disease (SR-aGVHD)

NEW YORK, July 21, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, announced today that the confirmatory Phase 3 trial of its allogeneic, immunoselected, and industrially manufactured stromal cell product rexlemestrocel-L in patients with chronic low back pain (CLBP) due to inflammatory degenerative disc disease of less than five years duration has commenced enrollment at multiple sites across the United States.

Patient Enrollment Commenced in Pivotal Phase 3 Trial of Rexlemestrocel-L for Chronic Low Back Pain

NEW YORK, July 08, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, announced today it has resubmitted its BLA for approval of Ryoncil® (remestemcel-L) in the treatment of children with SR-aGVHD.

Mesoblast Resubmits Biologics License Application (BLA) with United States Food & Drug Administration (FDA) for Approval of Ryoncil® in Children with Steroid-Refractory Acute Graft-Versus-Host Disease (SR-aGVHD)

Mesoblast (MESO) skyrockets 208.2% year to date on encouraging progress with its pipeline candidates.

Mesoblast (MESO) Soars 208% YTD on Positive Regulatory Updates

NEW YORK, July 01, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today confirmed that it will file its Biologics License Application (BLA) for approval of Ryoncil® (remestemcel-L) in the treatment of children with steroid-refractory acute graft versus host disease (SR-aGVHD) with the U.S. Food and Drug Administration (FDA) next week.

Mesoblast to File Biologics License Application for Ryoncil® FDA Approval Next Week

NEW YORK, June 02, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), Chief Executive Silviu Itescu provided a corporate update at the Bell Potter Emerging Leaders Conference.

Mesoblast Corporate Presentation at Investor Conference

FDA Provides Clarity on Path to Licensure for Remestemcel-L in SR-aGVHD and Rexlemestrocel-L in End-Stage Heart Failure FDA Provides Clarity on Path to Licensure for Remestemcel-L in SR-aGVHD and Rexlemestrocel-L in End-Stage Heart Failure

Appendix 4c Quarterly Activity Report for Quarter Ended March 31, 2024

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Mesoblast (MESO) gains as the FDA states that the available phase III data for lead candidate, remestemcel-L, is sufficient to support a regulatory filing for pediatric SR-aGVHD indication.

News for Mesoblast Stock (MESO)