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. 02, 2022 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, announced today that it has submitted to the U.S. Food and Drug Administration (FDA) substantial new information on clinical and potency assay items identified in the Complete Response Letter (CRL) received from FDA in September 2020 to the Biologics License Application (BLA) for remestemcel-L in the treatment of children with steroid-refractory acute graft versus host disease (SR-aGVHD).

Mesoblast Submits New Information to FDA IND File in Response to Items in the CRL to the Remestemcel-L BLA for SR-aGVHD

Mesoblast Limited (NASDAQ:MESO ) Q4 2022 Earnings Conference Call August 30, 2022 6:30 PM ET Company Participants Silviu Itescu - CEO and MD Andrew Chaponnel - Interim CFO Eric Rose - Chief Medical Officer Conference Call Participants Michael Okunewitch - Maxim Group Edward Tenthoff - Piper Sandler Operator Thank you for standing by. And welcome to the Mesoblast Limited 2022 Full Year Financial Results Conference Call.

Mesoblast Limited (MESO) Q4 2022 Earnings Call Transcript

NEW YORK, Aug. 30, 2022 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today reported financial results and operational highlights for the period ended June 30, 2022 and provided an update on upcoming milestones.

Mesoblast Reports Financial Results and Operational Highlights for Fiscal Year Ended June 30, 2022

NEW YORK, Aug. 29, 2022 (GLOBE NEWSWIRE) -- Mesoblast Limited (ASX:MSB; Nasdaq:MESO), global leader in allogeneic cellular medicines for inflammatory diseases, will host a webcast to discuss operational highlights and financial results for the fourth quarter and full-year ended June 30, 2022.

Mesoblast Corporate Update and Financial Results Webcast

NEW YORK, Aug. 18, 2022 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that it has appointed Jane Bell to its Board of Directors. Ms Bell is a banking and finance lawyer with 22 years of corporate finance expertise focussing on international investment transactions in the United States, Canada, Australia and the United Kingdom, including funds management, mergers, acquisitions, and divestments. She has served as a non-executive Director in a diverse range of highly regulated sectors including delivery of healthcare, life sciences, medical research, and funds management.

Jane Bell Joins Mesoblast Board

NEW YORK, July 11, 2022 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that rexlemestrocel-L, its allogeneic “off-the-shelf” product candidate for the treatment of chronic heart failure (CHF) with reduced ejection fraction (HFrEF), will be highlighted in a panel discussion titled “Late-Stage Advancements in Heart Failure Therapeutics and Management”, presented by Maxim Group LLC and hosted by M-Vest, on Thursday, July 14th, 2022 at 10:00 a.m. ET. The link to the webcast is available here.

Rexlemestrocel-L to be Highlighted at Maxim's Panel on Late-Stage Advancements in Heart Failure Therapeutics and Management

Chronic Low Back Pain due to Degenerative Disc Disease Chronic Low Back Pain due to Degenerative Disc Disease

Mesoblast Key Opinion Leader Event Series for Investors & Analysts

Substantial Reduction in Operational Spend while Maintaining Focus on BLA Resubmission Substantial Reduction in Operational Spend while Maintaining Focus on BLA Resubmission

Operational Highlights and Financial Results for the Period Ended March 31, 2022

NEW YORK, March 23, 2022 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that Philip R. Krause, M.D. has joined its Board of Directors. Dr. Krause was for the past decade Deputy Director, Office of Vaccines Research and Review (OVRR) at the US Food and Drug Administration (FDA)'s Center for Biologics Evaluation and Research (CBER). Dr. Krause is currently Chair of the World Health Organization COVID Vaccines Research Expert Group, and most recently he shared responsibility for regulatory authorizations of COVID-19 vaccines in the US.

Philip R. Krause, M.D., Former FDA Deputy Chief for Vaccines, Joins Mesoblast Board

Mesoblast Prepares for Resubmission of Biologics License Application Mesoblast Prepares for Resubmission of Biologics License Application

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

Results of First Patient Cohort from Randomized Controlled Study Presented at Congress of European Crohn's and Colitis Organisation (ECCO) Results of First Patient Cohort from Randomized Controlled Study Presented at Congress of European Crohn's and Colitis Organisation (ECCO)

Rapid Improvement and Remission in Patients With Refractory Ulcerative Colitis and Crohn's Colitis After Direct Injection of Remestemcel-L by Colonoscopy

NEW YORK, Feb. 01, 2022 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, is pleased to announce the appointment of Dr. Eric Rose as the Company's Chief Medical Officer (CMO). Dr. Rose has been a non-executive director of Mesoblast since 2013. In his new role as a key executive, Dr. Rose brings to Mesoblast an extensive record of excellence in clinical development and successful interactions at the highest levels with key regulatory, industry and government stakeholders including the United States Food and Drug Administration (FDA), the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA).

Mesoblast Appoints Dr. Eric Rose as Chief Medical Officer

NEW YORK, Jan. 24, 2022 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, announced today it is participating in Edison Group's Open House Event, scheduled to take place virtually this week. The three-day event, in association with London Stock Exchange, global law firm Taylor Wessing and OpenExchange, will take place between January 25-27th, focusing on 33 companies. Mesoblast will feature on Day one - Businesses within Pharmaceuticals & Drug Discovery.

Mesoblast to Participate in Edison Group's Global Healthcare “Open House” Virtual Conference From January 25-27th, 2022

Mesoblast Limited (NASDAQ: MESO) announced 36-month follow-up results from the 400-subject Phase 3 trial of its allogeneic cell therapy rexlemestrocel-L in patients with chronic low back pain (CLBP) associated with degenerative disc disease (DDD).  The data showed a durable reduction in back pain lasting at least three years from a single intra-discal injection of rexlemestrocel-L+hyaluronic acid (HA) carrier.

Single Dose Of Mesoblast's Cell Therapy Shows Durable Reduction In Back Pain

36-Month Results of Phase 3 Trial in Chronic Low Back Pain Presented at 2022 Biotech Showcase 36-Month Results of Phase 3 Trial in Chronic Low Back Pain Presented at 2022 Biotech Showcase

Single Dose of Mesoblast's Allogeneic Cell Therapy Provides Durable Pain Reduction for at Least Three Years in Patients With Degenerative Disc Disease

Mesoblast Provides Update Following Meeting With FDA's OTAT on Remestemcel-L for Children With Acute Graft Versus Host Disease

Mesoblast Limited (NASDAQ: MESO) received feedback from the FDA's Office of Tissues and Advanced Therapies (OTAT) on the Phase 3 program of rexlemestrocel-L in patients. The trial is assessing rexlemestrocel-L in patients with chronic low back pain (CLBP) due to degenerative disc disease refractory to available therapies, including opioids.

FDA's Office Agrees On 12-Month Reduction In Pain As Primary Endpoint For Mesoblast's Back Pain Study

NEW YORK, Dec. 15, 2021 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that it has received feedback from the US Food & Drug Administration's (FDA) Office of Tissues and Advanced Therapies (OTAT) on the Phase 3 program of rexlemestrocel-L in patients with chronic low back pain (CLBP) due to degenerative disc disease (DDD) refractory to available therapies, including opioids.

FDA's OTAT in Agreement With 12-Month Reduction in Pain as Primary Endpoint for Chronic Low Back Pain Program

The heavy selling pressure might have exhausted for Mesoblast Limited (MESO) as it is technically in oversold territory now. In addition to this technical measure, strong agreement among Wall Street analysts in revising earnings estimates higher indicates that the stock is ripe for a trend reversal.

Down 35.1% in 4 Weeks, Here's Why You Should You Buy the Dip in Mesoblast Limited (MESO)

Mesoblast Limited (NASDAQ: MESO) shares are trading lower after the company was notified by Novartis that it has chosen to terminate the agreement with Mesoblast prior to closing. Mesoblast said the company remains highly focused on executing on their short term objective to bring remestemcel-L to market for patients with acute respiratory distress syndrome (ARDS) due to COVID-19.

Why Mesoblast Shares Are Falling

NEW YORK, Dec. 13, 2021 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, was notified today by Novartis that it has chosen to terminate the agreement with Mesoblast prior to closing. Mesoblast remains highly focused on executing on our short term objective to bring remestemcel-L to market for patients with acute respiratory distress syndrome (ARDS) due to COVID-19.

Update on Novartis Agreement

Mesoblast Limited (NASDAQ: MESO) announced new analyses from the landmark DREAM-HF Phase 3 trial of rexlemestrocel-L in HFrEF patients with diabetes and/or ischemia who are at high risk of cardiovascular mortality, heart attacks, or strokes. In recent guidance to Mesoblast, FDA confirmed that reduction in the incidence of cardiovascular mortality or irreversible morbidity is a clinically meaningful acceptable endpoint and encouraged Mesoblast to identify the highest-risk group with the greatest likelihood of beneficial response.

Mesoblast's Heart Failure Candidate Shows Treatment Benefit In High-Risk Patients

Endpoint in Line with FDA Guidance on Key Outcomes in High-Risk Patients and with Pharma Industry Drugs Approved for Cardiovascular Risk Reduction in Diabetes Endpoint in Line with FDA Guidance on Key Outcomes in High-Risk Patients and with Pharma Industry Drugs Approved for Cardiovascular Risk Reduction in Diabetes

Rexlemestrocel-L Shows Greatest Treatment Benefit on Major Adverse Cardiovascular Events in High-Risk Heart Failure Patients With Diabetes and/or Myocardial Ischemia

After losing some value lately, a hammer chart pattern has been formed for Mesoblast Limited (MESO), indicating that the stock has found support. This, combined with an upward trend in earnings estimate revisions, could lead to a trend reversal for the stock in the near term.

Mesoblast Limited (MESO) Forms 'Hammer Chart Pattern': Time for Bottom Fishing?

The average of price targets set by Wall Street analysts indicates a potential upside of 156.9% in Mesoblast Limited (MESO). While the effectiveness of this highly sought-after metric is questionable, the positive trend in earnings estimate revisions might translate into an upside in the stock.

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