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.

NEW YORK, Oct. 01, 2020 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, announced today that the US Food and Drug Administration (FDA) has issued a Complete Response Letter to its Biologics License Application (BLA) for remestemcel-L for the treatment of pediatric steroid-refractory acute graft versus host disease (SR-aGVHD). While the Oncologic Drugs Advisory Committee (ODAC)1 of the FDA voted 9:1 that the available data support the efficacy of remestemcel-L in pediatric patients with SR-aGVHD, the FDA recommended that Mesoblast conduct at least one additional randomized, controlled study in adults and/or children to provide further evidence of the effectiveness of remestemcel-L for SR-aGVHD. As there are currently no approved treatments for this life-threatening condition in children under 12, Mesoblast will urgently request a Type A meeting with the FDA, expected within 30 days, to discuss a potential accelerated approval with a post-approval condition for an additional study.

Mesoblast Receives Complete Response Letter From the FDA for Biologics License Application for Steroid-Refractory Acute Graft Versus Host Disease in Children

Trading in shares of Australian biopharma Mesoblast limited (NASDAQ: MESO) was halted on the Nasdaq exchange Wednesday pending the release of material news. The Mesoblast Trading Halt: Earlier, the Australian stock exchange made an announcement regarding the halt, stating that trading in Mesoblast stock was halted at the request of the company.

Mesoblast Shares Halted: A Look At Biotech's Upcoming Catalysts

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NEW YORK, Sept.  15, 2020  (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that its lead product candidate remestemcel-L has been selected as the winner of the Fierce Innovation Awards - Life Sciences Edition 2020 for Biotech Innovation. The Fierce Innovation Awards is a peer-reviewed program from the publisher of FierceBiotech and FiercePharma. 

Mesoblast Wins 2020 Fierce Biotech Innovation of the Year Award for remestemcel-L

NEW YORK, Sept.  04, 2020  (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq: MESO; ASX: MSB) today announced that the independent Data Safety Monitoring Board (DSMB) recommended continuation of the Phase 3 trial of remestemcel-L in patients with moderate to severe acute respiratory distress syndrome (ARDS) due to COVID-19 infection, following completion of trial’s first interim analysis. The analysis was performed on the first 30% of the total target of randomized patients, with the DSMB reviewing the trial’s primary endpoint, all-cause mortality within 30 days of randomization and all safety data.

Data Safety Monitoring Board Recommends Continuation of Remestemcel-L Phase 3 Trial in COVID-19 Patients With Acute Respiratory Distress Syndrome

NEW YORK, Sept.  02, 2020  (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that it has received ethics approval to include Australian hospitals in the Phase 3 randomized controlled trial of remestemcel-L in ventilator-dependent COVID-19 patients with acute respiratory distress syndrome (ARDS).

Mesoblast Receives Ethics Approval to Treat COVID-19 Patients in Australia

Mesoblast Before The PDUFA

Mesoblast Limited (MESO) CEO Silviu Itescu on Q4 2020 Results - Earnings Call Transcript

NEW YORK--(BUSINESS WIRE)--Rosen Law Firm, a global investor rights law firm, continues its investigation of potential securities claims on behalf of shareholders of Mesoblast Limited (NASDAQ: MESO) resulting from allegations that Mesoblast may have issued materially misleading business information to the investing public. On August 11, 2020, the U.S.

ROSEN, A LEADING NATIONAL LAW FIRM, Continues Investigation of Securities Claims Against Mesoblast Limited; Encourages Investors with Losses in Excess of $100K to Contact the Firm – MESO

Mesoblast Well Prepared Ahead of First Potential US Product Launch Mesoblast Well Prepared Ahead of First Potential US Product Launch

Mesoblast Reports Substantial Operational Progress and Financial Results for the Year Ended June 30, 2020

NEW YORK, Aug.  25, 2020  (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in cellular medicines for inflammatory diseases, will host a webcast to discuss its financial and operational highlights for the fourth quarter and full-year ended June 30, 2020 (FY2020).

Mesoblast 2020 Full Year Financial Results Webcast

LOS ANGELES--(BUSINESS WIRE)---- $MESO #MESO--INVESTIGATION REMINDER: The Schall Law Firm Announces it is Investigating Claims Against Mesoblast Limited

INVESTIGATION REMINDER: The Schall Law Firm Announces it is Investigating Claims Against Mesoblast Limited and Encourages Investors with Losses of $100,000 to Contact the Firm

LOS ANGELES--(BUSINESS WIRE)---- $MESO #MESO--INVESTIGATION ALERT: The Schall Law Firm Announces it is Investigating Claims Against Mesoblast Limited

INVESTIGATION ALERT: The Schall Law Firm Announces it is Investigating Claims Against Mesoblast Limited and Encourages Investors with Losses of $100,000 to Contact the Firm

NEW YORK--(BUSINESS WIRE)--Rosen Law Firm, a global investor rights law firm, announces an investigation of potential securities claims on behalf of shareholders of Mesoblast Limited (NASDAQ: MESO) resulting from allegations that Mesoblast may have issued materially misleading business information to the investing public. On August 11, 2020, the U.S.

MESO EQUITY ALERT: Rosen Law Firm Announces Investigation of Securities Claims Against Mesoblast Limited – MESO

Mesoblast (MESO) gets ODAC's vote in the ratio of 9:1 for GVHD drug.

Mesoblast Gets Favorable Votes From FDA Committee for Ryoncil

The small biotech received good news from an FDA advisory committee.

Why Mesoblast Stock Is Skyrocketing Today

Mesoblast (NASDAQ: MESO) shares are trading higher after the company announced the Oncologic Drugs Advisory Committee of the FDA voted in favor of its RYONCIL for efficacy in children with steroid-refractory acute graft versus host disease.

Why Mesoblast's Stock is Trading Higher Today

NEW YORK, Aug.  14, 2020  (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in cellular medicines for inflammatory diseases, today announced that the Oncologic Drugs Advisory Committee (ODAC) of the United States Food and Drug Administration (FDA) voted overwhelmingly in favor that the available data support the efficacy of remestemcel-L (RYONCIL™) in pediatric patients with steroid-refractory acute graft versus host disease (SR-aGVHD).

U.S. FDA Advisory Committee Votes Nine to One in Favor of Remestemcel-L (Ryoncil™) for Efficacy in Children With Steroid-Refractory Acute Graft Versus Host Disease

The Australian stem-cell company will face some pointed questions from regulators about how it manufactures stem cells.

Mesoblast Plunges as FDA Questions Cell-Therapy Manufacturing

NEW YORK, Aug.  11, 2020  (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB) today provided an update on the scheduled meeting of the Oncologic Drugs Advisory Committee (ODAC) of the United States Food and Drug Administration (FDA) which will review data supporting the Company’s Biologics License Application (BLA) for approval of RYONCIL™ (remestemcel-L) in the treatment of steroid-refractory acute graft versus host disease (SR-aGVHD) in children. There are currently no FDA-approved treatments in the United States for children under 12 with SR-aGVHD, a potentially life-threatening complication of an allogeneic bone marrow transplant for blood cancer.

Update on Scheduled FDA Advisory Committee Meeting

NEW YORK, July  30, 2020  (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided an update on upcoming milestones for its lead product candidate remestemcel-L, and an activity report for the fourth quarter ended June 30, 2020.

Mesoblast Provides Remestemcel-L Update and Quarterly Activity Report

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NEW YORK, July  24, 2020  (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq: MESO; ASX: MSB), global leader in cellular medicines for inflammatory diseases, today announced the appointment of Dagmar Rosa-Bjorkeson to the role of Chief Operating Officer (COO), based in New York. Ms Rosa-Bjorkeson’s responsibilities will include managing commercial operations, leading the business units, building out key strategic alliances, and overseeing product launches. She will be part of an expanded executive leadership structure that will deliver deep operational, commercial, and strategic pharmaceutical experience in line with the Company’s transition to becoming a fully integrated commercial organization.  

Executive Leadership Expanded Ahead of First Potential U.S. Product Launch

NEW YORK, July  21, 2020  (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB) today announced that the Oncologic Drugs Advisory Committee (ODAC) of the United States Food and Drug Administration (FDA) has scheduled a meeting on August 13, 2020 to review data supporting the Company’s Biologics License Application (BLA) for approval of RYONCIL™ (remestemcel-L) for the treatment of steroid-refractory acute graft versus host disease (SR-aGVHD) in children.

FDA Advisory Committee Sets Review Date for Mesoblast’s remestemcel-L in Pediatric Steroid-Refractory Acute Graft Versus Host Disease

MESO has been approved to sell remestemcel-l (labeled TEMCELL by partner JCR Pharmaceuticals) for acute Graft vs Host disease (aGVHD) in Japan for several years.

News for Mesoblast Stock (MESO)