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, April 25, 2023 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced it has completed a global private placement primarily to Mesoblast's existing major US, UK, and Australian shareholders raising approximately US$40 million, net of transaction costs, at A$0.85 per share.

Mesoblast Completes Private Placement

Biologics License Application (BLA) Resubmission for Pediatric Acute Graft-Versus-Host Disease (SR-aGVHD) Currently Being Reviewed

FDA Schedules Pre-License Inspection of Remestemcel-L Manufacturing

Mesoblast (MESO) announces the FDA acceptance for review of the resubmitted biological license application for remestemcel-L for the treatment of children under 12 with steroid-refractory acute graft versus host disease. Stock gains on Wednesday, following the news.

Mesoblast's (MESO) GVHD Drug BLA Gets FDA Priority Tag, Stock Up

If Approved, Remestemcel-L will be the First Allogeneic “Off-the-Shelf” Cellular Medicine in the US, and the First Therapy for Children Under 12 Years Old with SR-aGVHD. If Approved, Remestemcel-L will be the First Allogeneic “Off-the-Shelf” Cellular Medicine in the US, and the First Therapy for Children Under 12 Years Old with SR-aGVHD.

FDA Accepts Mesoblast's Resubmission of the Biologic License Application for Remestemcel-L In Children with Steroid-Refractory Acute Graft Versus Host Disease as a Complete Response and Sets Goal Date of August 2, 2023

Mesoblast Limited. (NASDAQ:MESO ) Q2 2023 Earnings Conference Call February 27, 2023 4:30 PM ET Company Participants Silviu Itescu – Chief Executive Officer Andrew Chaponnel – Chief Financial Officer Conference Call Participants Edward Tenthoff – Piper Sandler Swayampakula Ramakanth – HCW Silviu Itescu [Call Starts Abruptly] Thank you very much, operator.

Mesoblast Limited. (MESO) Q2 2023 Earnings Call Transcript

NEW YORK, Feb. 27, 2023 (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 December 31, 2022.

Mesoblast Reports Operational and Financial Highlights for Quarter Ended December 31, 2022

Single Intra-Myocardial Intervention with Rexlemestrocel-L Reduced Cardiovascular Death, Myocardial Infarction or Stroke Over Mean Follow-Up of 30 Months in High-Risk Patients with Chronic Heart Failure Single Intra-Myocardial Intervention with Rexlemestrocel-L Reduced Cardiovascular Death, Myocardial Infarction or Stroke Over Mean Follow-Up of 30 Months in High-Risk Patients with Chronic Heart Failure

DREAM-HF Phase 3 Trial Results for Mesoblast Cell Therapy in Heart Failure Published in Journal of the American College of Cardiology (JACC)

NEW YORK, Feb. 16, 2023 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that two studies on the remestemcel-L development program for the treatment of children with steroid-refractory acute graft versus host disease (SR-aGVHD) were selected by peer review to be presented at the 2023 Tandem Meetings of the American Society for Transplantation and Cellular Therapy (ASTCT) and the Center for Blood and Marrow Transplant Research (CIBMTR), taking place February 15-19 in Orlando, Florida.

Remestemcel-L Clinical and Potency Studies Presented at Premier Meeting of Transplantation Research and Therapy

NEW YORK, Feb. 08, 2023 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that the United States Food and Drug Administration's (FDA) Office of Tissues and Advanced Therapies (OTAT) has granted Regenerative Medicine Advanced Therapy (RMAT) designation for rexlemestrocel-L in the treatment of chronic low back pain (CLBP) associated with disc degeneration, in combination with hyaluronic acid (HA) as delivery agent for injection into the lumbar disc.

FDA Grants Regenerative Medicine Advanced Therapy (Rmat) Designation for Rexlemestrocel-L in Chronic Low Back Pain

Validation of Remestemcel-L Potency Assay used in the Phase 3 Trial which Measures In-Vivo Activity based on Mechanism of Action

Mesoblast Resubmits Biologic License Application (BLA) to FDA for Remestemcel-L in Children With Steroid-Refractory Acute Graft Versus Host Disease (Sr-aGVHD)

NEW YORK, Dec. 22, 2022 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that funds managed by Oaktree Capital Management, L.P. (“Oaktree”) have extended to Mesoblast the availability of up to an additional US$30.0 million of its US$90 million five year facility subject to achieving certain milestones on or before September 30, 2023.

Mesoblast and Oaktree Extend Availability Period of Undrawn Tranches of Financing Facility

Mesoblast Limited (MESO) has been upgraded to a Zacks Rank #2 (Buy), reflecting growing optimism about the company's earnings prospects. This might drive the stock higher in the near term.

Mesoblast Limited (MESO) Upgraded to Buy: Here's What You Should Know

Mesoblast Limited (NASDAQ:MESO ) Q1 2023 Results Conference Call November 22, 2022 4:30 PM ET Company Participants Dr. Silviu Itescu - CEO and MD Andrew Chaponnel - Interim CFO Dr. Eric Rose - Chief Medical Officer Conference Call Participants Carvey Leung - Cantor Fitzgerald Edward Tenthoff - Piper Sandler Dr. Silviu Itescu Good morning, good afternoon to the operational highlights and financial results for the quarter ended September 30, 2022, as well as our upcoming Annual General Meeting. Apologies for the slight delay due to technical difficulties; beyond our control.

Mesoblast Limited (MESO) Q1 2023 Earnings Call Transcript

Children Treated With Remestemcel-L Show Long-Term Survival Through Four Years in Steroid-Refractory Acute Graft Versus Host Disease (SR-aGVHD)

Durable long-term survival outcomes through 4 years for children with steroid-refractory graft versus host disease (SR-aGVHD) treated with remestemcel-L

Mesoblast Reports Financial Results and Operational Highlights for the Period Ended September 30, 2022

Quarterly Activity Report Quarterly Activity Report

Mesoblast Operational and Financial Highlights for Quarter Ended September 30, 2022

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.

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