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, July 18, 2021 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, presented 90-day survival outcomes from the 222-patient randomized controlled trial of remestemcel-L in ventilator-dependent COVID-19 patients with moderate/severe acute respiratory distress syndrome (ARDS) at an invited presentation on July 17 to the International Society for Cell & Gene Therapy (ISCT) Scientific Signatures Series on Cell and Gene Therapies in Lung Diseases and Critical Illnesses. The results showed that two doses of remestemcel-L at days 3-5 conferred durable survival benefit through at least 90 days in the pre-specified subgroup of patients under age 65.

Ninety Day Survival Outcomes in COVID-19 ARDS Trial of Remestemcel-L Presented at ISCT Meeting on Advances in Cell & Gene Therapies for Lung Diseases

NEW YORK, July 15, 2021 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today presented clinical outcomes from the randomized controlled trial of remestemcel-L in ventilator-dependent COVID-19 patients with moderate/severe acute respiratory distress syndrome (ARDS). Results of respiratory function were highlighted at the biennial Stem Cells, Cell Therapies, and Bioengineering in Lung Biology and Diseases conference hosted by the University of Vermont, Burlington, VT, on July 15. The invited presentation was given by Mesoblast Chief Executive Officer, Dr Silviu Itescu, and materials have been lodged with the ASX.

Mesoblast Presents Respiratory Function Results of COVID-19 ARDS Trial at Pulmonary Disease Conference

Mesoblast Limited (NASDAQ: MESO) provided an update on the strategy for bringing rexlemestrocel-L to patients in the U.S. with chronic low back pain (CLBP) due to degenerative disc disease refractory to available therapies. The company has filed a request and expects to hold a Type C meeting with the FDA during the current quarter to discuss the pathway to U.S. regulatory approval for rexlemestrocel-L following the recently completed Phase 3 trial.

Mesoblast Updates On Rexlemestrocel-L Program In Chronic Low Back Pain

NEW YORK, June 30, 2021 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided an update on the strategy for bringing rexlemestrocel-L to patients in the United States (US) with chronic low back pain (CLBP) due to degenerative disc disease (DDD) refractory to available therapies, including opioids. Excessive use of opioids in this patient population continues to be a major focus for US healthcare policymakers, regulatory authorities, patients and physicians, with more than 50% of US opioid prescriptions being for the treatment of CLBP.1,6,7

Mesoblast Provides Update on Program for Chronic Low Back Pain Due to Degenerative Disc Disease

NEW YORK, June 02, 2021 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today reported operational highlights and financial results for the period ended March 31, 2021.

Operational Highlights and Financial Results for the Period Ended March 31, 2021

NEW YORK, May 25, 2021 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that the peer-reviewed journal Respiratory Research has published results showing that Mesoblast's mesenchymal stromal cell (MSC) product candidate remestemcel-L significantly improved respiratory and functional clinical outcomes in patients with chronic obstructive pulmonary disease (COPD) and elevated levels of the inflammatory biomarker C-reactive protein (CRP). Patients with COPD and elevated CRP levels have increased rates of hospitalization and death.1 These results provide further rationale for potential use of remestemcel-L in inflammatory lung diseases, including COVID-19 acute respiratory distress syndrome (ARDS).

Improved Outcomes in Inflammatory Lung Disease With Remestemcel-L Published in Respiratory Research Journal

Mesoblast Limited (MESO) witnessed a jump in share price last session on above-average trading volume. The latest trend in earnings estimate revisions for the stock doesn't suggest further strength down the road.

Strength Seen in Mesoblast Limited (MESO): Can Its 6.1% Jump Turn into More Strength?

The company announced positive results from a clinical trial.

Why Mesoblast Limited Stock Is Jumping Today

The stock price of Mesoblast Limited (Nasdaq: MESO) increased from $7.22 to a day high of $8.99 during intraday trading this morning. This is why it happened.

MESO Stock: From $7.22 To $8.99 Explanation

Mesoblast Limited (NASDAQ: MESO) has announced 60-day results from the randomized controlled trial of remestemcel-L in COVID-19 patients with moderate/severe acute respiratory distress syndrome (ARDS), which had been halted after the third interim analysis, as previously announced. The trial enrolled 222 mechanically ventilated COVID-19 patients.

Mesoblast Shares Rise As Remestemcel-L Cuts Mortality In Patients Below 65 Years With COVID-19 Related Respiratory Distress

NEW YORK, March 30, 2021 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided an overview of the Company's recent operational highlights, as well as upcoming milestones.

Mesoblast Operational Highlights and Upcoming Milestones

NEW YORK, March 08, 2021 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, announced today the successful completion and settlement of its US$110 million private placement led by a strategic US investor group, that was announced on Tuesday, March 2, 2021.

Mesoblast Closes US$110/A$138 Million Financing Led by US Strategic Investor Group

NEW YORK, Feb. 17, 2021 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that Pediatrics (Journal of the American Academy of Pediatrics) has published a paper on the first two children treated with Mesoblast's mesenchymal stromal cell (MSC) product candidate remestemcel-L for life-threatening multisystem inflammatory syndrome (MIS-C) associated with COVID-19.

Positive Outcomes of First Children Treated With Remestemcel-L for Multisystem Inflammatory Syndrome (MIS-C) and Heart Failure Post-COVID-19 Published in Pediatrics

One of its pipeline candidates achieved great results in a late-stage clinical study.

Why Mesoblast Limited Is Rising Today

Positive results from Mesoblast Limited's (NASDAQ: MESO) chronic back pain treatment trial have boosted investor confidence sending the company's shares higher in the premarket after an announcement showing its stem cell treatment for chronic lower back pain is “safe, durable, and effective.” Phase 3 trial results have shown that a single injection of rexlemestrocel-L in 404 enrolled patients suffering from lower back pain due to degenerative disc disease results in at least two years of pain reduction.

Mesoblast Spikes On Positive Cell Therapy Data in Back Pain Study

NEW YORK, Feb. 10, 2021 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced results from the Phase 3 randomized controlled trial of its allogeneic mesenchymal precursor cell (MPC) therapy rexlemestrocel-L in 404 enrolled patients with chronic low back pain (CLBP) due to degenerative disc disease (DDD) refractory to conventional treatments. The results indicate that a single injection of rexlemestrocel-L may provide a safe, durable, and effective opioid-sparing therapy for patients with chronic inflammatory back pain due to degenerative disc disease, and that greatest benefits are seen when administered earlier in the disease process before irreversible fibrosis of the intervertebral disc has occurred.

Mesoblast Phase 3 Trial Shows That a Single Injection of Rexlemestrocel-L + Hyaluronic Acid Carrier Results in at Least Two Years of Pain Reduction With Opioid Sparing Activity in Patients With Chronic Low Back Pain Due to Degenerative Disc Disease

NEW YORK, Jan. 28, 2021 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided an update on its pipeline of late-stage product candidates, and an activity report for the second quarter ended December 31, 2020.

Mesoblast Operational and Financial Highlights for Quarter Ended December 31, 2020

Investors need to pay close attention to Mesoblast (MESO) stock based on the movements in the options market lately.

Is the Options Market Predicting a Spike in Mesoblast (MESO) Stock?

NEW YORK, Jan. 11, 2021 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, announced that its Chief Executive Officer, Dr Silviu Itescu, today presented additional data from the landmark DREAM-HF Phase 3 trial in patients with chronic heart failure. The presentation materials have been lodged with the ASX, and Mesoblast's presentation at the H.C. Wainwright Virtual BioConnect 2021 Conference can be accessed at https://journey.ct.events/view/f353f7fd-772e-43aa-aab0-e959da38254d . An archived webcast of the conference presentation will be available for 90 days on the Company's website at www.mesoblast.com .

Mesoblast Presents Heart Failure Phase 3 Trial Results at Investor Healthcare Conference

Why Mesoblast Stock Skyrocketed Today

NEW YORK, Jan. 11, 2021 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced additional results from the landmark DREAM-HF randomized controlled Phase 3 trial in 537 treated patients with chronic heart failure with reduced left ventricular ejection fraction (HFrEF) who received rexlemestrocel-L (REVASCOR®) or control sham. A single dose of rexlemestrocel-L resulted in substantial and durable reductions in heart attacks, strokes, and cardiac deaths. Since existing therapies have only minimal or no benefit on these endpoints, these notable outcomes may signal a breakthrough in addressing the principal unmet needs in patients with chronic heart failure. The results of this trial identify New York Heart Association (NYHA) class II HFrEF patients as the optimal target population for greatest rexlemestrocel-L treatment effect, and therefore a focus for registration and commercialization of rexlemestrocel-L in the largest market in heart failure.

Single Dose of Rexlemestrocel-L Provides Substantial and Durable Reduction in Heart Attacks, Strokes and Cardiac Death in Patients With Chronic Heart Failure

Investors are losing confidence because the company disappointed in a late-stage trial for the second time this week.

Why Mesoblast Stock Plummeted on Friday

NEW YORK, Dec. 17, 2020 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, will host a webcast today to provide an update on the randomized controlled trial of remestemcel-L in ventilator-dependent patients with moderate to severe acute respiratory distress syndrome (ARDS) due to COVID-19 infection.

Mesoblast Webcast – Update on COVID-19 ARDS Trial

NEW YORK, Dec. 17, 2020 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB) today provided an update on the randomized controlled trial of remestemcel-L in ventilator-dependent patients with moderate to severe acute respiratory distress syndrome (ARDS) due to COVID-19 infection after the Data Safety Monitoring Board (DSMB) performed a third interim analysis on the trial's first 180 patients. The trial was powered to achieve a primary endpoint of 43% reduction in mortality at 30 days for treatment with remestemcel-L on top of maximal care in a trial of 300 patients. This projected mortality reduction was based on pilot data observed during the initial stages of the pandemic when control mortality rates were exceedingly high and prior to new evolving treatment regimens that have reduced disease mortality in ventilated patients. The DSMB reported that there were no safety concerns and noted that the trial is not likely to meet the 30-day mortality reduction endpoint at the planned 300 patient enrolment. The DSMB recommended that the trial complete with the currently enrolled 223 patients, and that all be followed-up as planned.

Mesoblast Update on COVID-19 ARDS Trial

The company reported disappointing results from a late-stage clinical study.

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