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.

The business raised new capital to ready for the next phase of expansion.

Here's Why Mesoblast Is Soaring Today

NEW YORK, May  13, 2020  (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq: MESO; ASX:MSB), a leader in cellular medicines for inflammatory diseases, announced today that it has successfully completed a capital raising of US$90 million¹ (A$138 million) via a private placement of 43 million shares to existing and new institutional investors at a price of A$3.20 per share. This represents a 7% discount to both the price at the close of trading May 8, 2020 and the five-day volume weighted average price (VWAP).

Mesoblast Successfully Completes Financing to Scale-Up Manufacturing of Remestemcel-L for COVID-19 ARDS

NEW YORK, May  06, 2020  (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in cellular medicines for inflammatory diseases, today announced that the first patients have been dosed in the 300-patient randomized placebo-controlled Phase 2/3 trial in the United States of Mesoblast’s allogeneic cellular medicine remestemcel-L in COVID-19 infected patients with moderate to severe acute respiratory distress syndrome (ARDS) on ventilator support.

First Patients Dosed in Phase 2/3 Randomized Controlled Trial  of Mesoblast’s Remestemcel-l for COVID-19 Acute Respiratory Distress Syndrome

NEW YORK, April  30, 2020  (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in cellular medicines for inflammatory diseases, today announced a Phase 2/3 randomized, placebo-controlled trial to rigorously confirm whether its allogeneic mesenchymal stem cell therapy remestemcel-L provides a survival benefit in moderate/severe acute respiratory distress syndrome (ARDS) due to COVID-19 has commenced enrollment.

Phase 2/3 Randomized Controlled Trial of Remestemcel-L in 300 Patients With COVID-19 Acute Respiratory Distress Syndrome Begins Enrollment

Athersys

Pluristem Therapeutics

Promising results from a very small study caused shares of stem cell stocks to soar, but investors shouldn't get too carried away just yet.

Are Stem Cells the COVID-19 Treatment We've All Been Waiting For?

The Australian stem-cell therapy developer presented promising data for COVID-19 patients days ago, but investors took some gains off the table today.

Shares of Mesoblast Tumbled Over 20% Today After Doubling Last Week

Inovio Pharmaceuticals

Moderna

The COVID-19 pandemic has been a major catalyst for these three biotech stocks.

Inovio Pharmaceuticals, Mesoblast, and Moderna: Are These Red-Hot Biotech Stocks Still a Buy?

The small-scale study, including just 12 patients, could signal big potential for the stem cell company's drug candidate.

Mesoblast Soars 219% on Promising COVID-19 Clinical Trial Data

Mesoblast Ltd. (NASDAQ: MESO) shares more than doubled on Friday after the company provided an update on its COVID-19 treatment.

Is This Mesoblast Move Overrated?

83% Survival in COVID-19 Patients with Moderate/Severe Acute Respiratory Distress Syndrome Treated in New York with Mesoblast’s Cell Therapy Remestemcel-L

NEW YORK, April  17, 2020  (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq: MESO; ASX:MSB) today announced that results using its allogeneic mesenchymal stem cell product candidate remestemcel-L in patients with inflammatory lung disease have been selected for oral presentation at the 2020 International Society of Cell and Gene Therapy (ISCT) annual meeting being held May 28-29, 2020. The virtual presentation is entitled ‘Mesenchymal Stem Cell Therapy Improves Pulmonary Function and Exercise Tolerance in Patients with Chronic Obstructive Pulmonary Disease (COPD) and High Baseline Inflammation’.

Mesoblast to Present Positive Clinical Outcomes Using Remestemcel-L in Patients With Inflammatory Lung Disease at 2020 International Society of Cell and Gene Therapy Annual Meeting

Gilead Sciences

Johnson & Johnson

Pfizer

Regeneron Pharmaceuticals

With the coronavirus outbreak gaining steam worldwide, pharma/biotech companies are evaluating every possible therapy to combat the spread.

Will Stem Cell Therapies Aid in Fight Against Coronavirus?

NEW YORK, April  08, 2020  (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB) today announced that its allogeneic mesenchymal stem cell (MSC) product candidate remestemcel-L will be formally evaluated in a randomized, placebo-controlled trial in 240 patients with acute respiratory distress syndrome (ARDS) caused by coronavirus infection (COVID-19). This multi-center Phase 2/3 trial will be conducted as a public-private partnership in a collaboration with the Cardiothoracic Surgical Trials Network (CTSN), which was established by the United States National Institutes of Health’s National Heart, Lung and Blood Institute (NHLBI) as a flexible platform for conducting collaborative trials. Mesoblast holds an Investigational New Drug (IND) Application from the United States Food and Drug Administration (FDA) for use of remestemcel-L in the treatment of patients with COVID-19 ARDS, and will provide investigational product for the trial.

MESOBLAST PARTNERS WITH THE CARDIOTHORACIC SURGICAL TRIALS NETWORK ESTABLISHED BY THE U.S. NATIONAL INSTITUTES OF HEALTH’S NATIONAL HEART, LUNG AND BLOOD INSTITUTE

NEW YORK, April  06, 2020  (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq: MESO; ASX:MSB), global leader in cellular medicines for inflammatory diseases, today announced that it has received clearance from the United States Food and Drug Administration (FDA) for an Investigational New Drug (IND) application to treat patients with acute respiratory distress syndrome (ARDS) caused by coronavirus infection (COVID-19) with intravenous infusions of its allogeneic mesenchymal stem cell (MSC) product candidate remestemcel-L. 

FDA CLEARS INVESTIGATIONAL NEW DRUG APPLICATION FOR MESOBLAST TO USE REMESTEMCEL-L IN PATIENTS WITH ACUTE RESPIRATORY DISTRESS SYNDROME CAUSED BY COVID-19

The FDA accepts Mesoblast's (MESO) BLA for Ryoncil (remestemcel-L) under a priority review to treat children with steroid-refractory acute graft versus host disease. A decision is pending on Sep 30.

Mesoblast's (MESO) BLA for Ryoncil Gets FDA Priority Review

Mesoblast Limited (NASDAQ: MESO) shares are trading higher on Wednesday. The company announced that the FDA accepted its biologics license application for RYONCIL and has agreed to a priority review.

Why Mesoblast's Stock Is  Trading Higher Today

NEW YORK, April  01, 2020  (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq: MESO; ASX:MSB), global leader in cellular medicines for inflammatory diseases, today announced that the United States Food and Drug Administration (FDA) has accepted for priority review the Company’s Biologics License Application (BLA) filing for RYONCILTM (remestemcel-L), its allogeneic cell therapy for the treatment of children with steroid-refractory acute graft versus host disease (SR-aGVHD). The FDA has set a Prescription Drug User Fee Act (PDUFA) action date of September 30, 2020, and if approved, Mesoblast will make RYONCIL immediately available in the United States.

FDA ACCEPTS MESOBLAST’S BIOLOGICS LICENCE APPLICATION FOR RYONCIL™ AND AGREES TO PRIORITY REVIEW

NEW YORK, March  30, 2020  (GLOBE NEWSWIRE) -- Results from a sub-study of 70 patients with end-stage ischemic heart failure and a Left Ventricular Assist Device (LVAD), of 159 randomized patients who received either Mesoblast’s allogeneic mesenchymal precursor cell (MPC) product candidate Revascor® or saline, were presented on March 28 at the American College of Cardiology (ACC) Virtual Scientific Sessions. The full results from these 70 patients will be published in a peer-reviewed journal.

CLINICAL OUTCOMES OF MESOBLAST’S CELL THERAPY IN END-STAGE ISCHEMIC HEART FAILURE PRESENTED AT AMERICAN COLLEGE OF CARDIOLOGY VIRTUAL SCIENTIFIC SESSIONS

Last week, Mesoblast Limited (NASDAQ: MESO) was plugging away at therapies for heart failure, chronic back pain and rheumatoid arthritis.

This Company Made Back Pain Therapies. Now It's Out For A COVID-19 Drug.

NEW YORK, March  10, 2020  (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq: MESO; ASX:MSB) today announced that it plans to evaluate its allogeneic mesenchymal stem cell (MSC) product candidate remestemcel-L in patients with acute respiratory distress syndrome (ARDS) caused by coronavirus (COVID-19) in the United States, Australia, China and Europe. The Company is in active discussions with various government and regulatory authorities, medical institutions and pharmaceutical companies to implement these activities.

Mesoblast To Evaluate Anti-Inflammatory Cell Therapy Remestemcel-L For Treatment Of COVID-19 Lung Disease

Mesoblast Limited (MESO) CEO Silviu Itescu on Q2 2020 Results - Earnings Call Transcript

NEW YORK, Feb.  24, 2020  (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB) today announced that aggregated results from 309 children treated with Ryoncil™ (remestemcel-L) were presented at the American Society for Transplantation Cellular Therapy and the Center for International Blood & Bone Marrow Transplant Research (TCT) meeting in Orlando, Florida on February 22. The data showed that treatment with RYONCIL across three separate trials resulted in consistent treatment responses and survival outcomes in children with steroid-refractory acute graft versus host disease (SR-aGVHD).

Consistent Outcomes Using Ryoncil™ as First-Line Treatment or Salvage Therapy in 309 Children With Steroid-Refractory Acute GVHD

NEW YORK, Feb.  20, 2020  (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in cellular medicines for inflammatory diseases, today announced that the investigator-initiated expanded access protocol using its cryopreserved allogeneic cell therapy product candidate remestemcel-L for steroid-refractory chronic graft versus host disease (chronic GVHD) has resulted in clinically meaningful outcomes in all three treated patients, two children and one adult, within 28 days after two infusions. On the basis of these outcomes, the investigator-initiated collaboration will be expanded to evaluate remestemcel-L in a pivotal trial for chronic GVHD. 

Clinically Meaningful Outcomes Using Remestemcel-L  In Patients With Chronic Graft Versus Host Disease

Mesoblast Submits BLA, And Other News: The Good, Bad And Ugly Of Biopharma

NEW YORK, Feb.  03, 2020  (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq: MESO; ASX:MSB), global leader in cellular medicines for inflammatory diseases, today announced that it has submitted its completed Biologics License Application (BLA) to the United States Food and Drug Administration (US FDA) for Ryoncil™ (remestemcel-L), its lead allogeneic cell therapy for the treatment of children with steroid-refractory acute graft versus host disease (SR-aGVHD).

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