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.

Earnings data Q2 2020

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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.

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.

Mesoblast Solving Unmet Medical Needs Including Severe ARDS Caused By COVID-19

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The Australian biopharma earned an important clearance to treat COVID-19 patients in the United States, which could be a sign of things to come.

Here's Why Mesoblast Stock Rose Over 18% Today

NEW YORK, July  06, 2020  (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB) today announced that an expanded access protocol (EAP) has been initiated in the United States for compassionate use of its allogeneic mesenchymal stem cell (MSC) product candidate remestemcel-L in the treatment of COVID-19 infected children with cardiovascular and other complications of multisystem inflammatory syndrome (MIS-C). Patients aged between two months and 17 years may receive one or two doses of remestemcel-L within five days of referral under the EAP.

Expanded Access Protocol Initiated for Compassionate Use of Remestemcel-L in Children With Multisystem Inflammatory Syndrome Associated With COVID-19

The cell therapy developer expects to have clinical data for its COVID-19 treatment soon. Will it deliver a historic success or continue the poor track record of stem cell candidates?

Is Wall Street Wrong About Mesoblast?

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Phase 2 Trial Results Presented At 2020 International Society for Cell & Gene Therapy Annual Meeting Phase 2 Trial Results Presented At 2020 International Society for Cell & Gene Therapy Annual Meeting

Remestemcel-L Improves Respiratory and Functional Outcomes in Patients With Inflammatory Lung Disease

Mesoblast Ltd. (MESO) CEO Silviu Itescu on Q3 2020 Results - Earnings Call Transcript

NEW YORK, May  27, 2020  (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today reported financial, corporate and operational highlights for the nine months ended March 31, 2020. Cash on hand at March 31, 2020 was US$60.1 million (A$97.3 million) and in May 2020, pro forma cash on hand was approximately US$150 million (A$235 million) after adjusting for a US$90 million (A$138 million) capital raise.

Mesoblast Reports Strong Financial Position and Substantial Operational Progress For the Period Ended March 31, 2020

Clinical Outcomes Using RYONCIL™ (remestemcel-L) in Children and Adults With Severe Inflammatory Graft Versus Host Disease Published in Three Articles in Biology of Blood and Marrow Transplantation

News for Mesoblast Stock (MESO)