Mesoblast Limited, a biopharmaceutical company, develops and commercializes allogeneic cellular medicines. The company offers products in the areas of cardiovascular, spine orthopedic disorder, oncology, hematology, and immune-mediated and inflammatory diseases. Its proprietary regenerative medicine technology platform is based on specialized cells known as mesenchymal lineage adult stem cells. The company's products under the Phase III clinical trials include MSC-100-IV for steroid refractory acute graft versus host disease; MPC-150-IM for advanced heart failure; and MPC-06-ID for chronic low back pain due to degenerative disc disease. It is also developing MPC-300-IV that is in Phase II clinical trials for the treatment of biologic refractory rheumatoid arthritis, diabetic kidney diseases, and type 2 diabetic nephropathy. It operates in the United States, Australia, Singapore, the United Kingdom, and Switzerland. Mesoblast Limited has strategic partnerships with Tasly Pharmaceutical Group to offer MPC-150-IM for heart failure and MPC-25-IC for heart attacks in China; JCR Pharmaceuticals Co. Ltd. for the treatment of wound healing in patients with epidermolysis bullosa; and Grünenthal to develop and commercialize cell therapy for the treatment of chronic low back pain. The company was founded in 2004 and is headquartered in Melbourne, Australia.
IPO Year: 2015
Exchange: NASDAQ
Website: mesoblast.com
| Date | Price Target | Rating | Analyst |
|---|---|---|---|
| 12/23/2024 | Buy → Hold | Jefferies | |
| 9/24/2024 | $12.00 | Hold → Buy | Maxim Group |
| 8/29/2024 | Hold → Buy | Jefferies | |
| 7/23/2024 | $4.00 → $11.00 | Neutral → Overweight | Piper Sandler |
| 8/31/2023 | Hold → Buy | Jefferies | |
| 8/7/2023 | Buy → Hold | Maxim Group | |
| 8/4/2023 | $7.00 → $2.00 | Overweight → Neutral | Piper Sandler |
| 8/4/2023 | Outperform → Mkt Perform | William Blair | |
| 3/9/2023 | $8.00 | Outperform | William Blair |
| 12/6/2022 | Buy → Hold | Jefferies |
NEW YORK, May 14, 2025 (GLOBE NEWSWIRE) -- Mesoblast (NASDAQ:MESO, ASX:MSB)), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that it has received seven years of orphan-drug exclusive approval from U.S. Food and Drug Administration (FDA) for Ryoncil® (remestemcel-L) for treatment of steroid-refractory acute graft versus host disease (SR-aGvHD) in pediatric patients 2 months of age and older. This period of statutory exclusivity means that the FDA will not approve another mesenchymal stromal or stem cell (MSC) products for this indication during the 7-year period from the approval of Ryoncil®. Separately, Mesoblast has biologic exclusivity prev
NEW YORK, April 29, 2025 (GLOBE NEWSWIRE) -- Mesoblast Limited (NASDAQ:MESO, ASX:MSB)), global leader in allogeneic cellular medicines for inflammatory diseases, today provided highlights of its recent activities for the third quarter ended March 31, 2025. "We were very pleased to have made Ryoncil® (remestemcel-L) commercially available to treat children with acute GVHD within one quarter of receiving FDA approval as the first mesenchymal stromal cell (MSC) therapy approved in the US for any indication," said Dr. Silviu Itescu, CEO of Mesoblast. "With our strong cash position we are well placed to expand Ryoncil® indications to other serious and life-threatening pediatric inflammatory di
NEW YORK, April 28, 2025 (GLOBE NEWSWIRE) -- Mesoblast (NASDAQ:MESO, ASX:MSB)), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that it has appointed Lyn Cobley to its Board of Directors. Ms. Cobley has been a global leader in the financial services industry with over 30 years' experience in senior positions at international and domestic banks. Ms. Cobley has served as CEO of Westpac Institutional Bank, Group Treasurer of Commonwealth Bank of Australia, and held senior roles at Barclays Capital and Citibank Limited. Ms. Cobley is currently a director of Commonwealth Bank of Australia, is a member of Chief Executive Women, a member of the Macquarie
NEW YORK, April 16, 2025 (GLOBE NEWSWIRE) -- Mesoblast (NASDAQ:MESO, ASX:MSB)), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that it has continued to expand coverage for Ryoncil® (remestemcel-L), the first mesenchymal stromal cell (MSC) therapy approved by U.S. Food and Drug Administration (FDA) for any indication, to 104 million US lives insured by government and commercial payers. To date, 37 of the 51 states provide fee-for-service Medicaid coverage for Ryoncil® through Orphan Drug Lists or medical exception / prior authorization (PA) process, representing 20 million covered lives, or 80% of the total Medicaid fee-for-service lives covered.
NEW YORK, April 03, 2025 (GLOBE NEWSWIRE) -- Mesoblast (NASDAQ:MESO, ASX:MSB)), global leader in allogeneic cellular medicines for inflammatory diseases, today provided an update on the status of its products in relation to the U.S. Government's announcement on tariffs for imported products. Mesoblast believes that its allogeneic cellular products, including Ryoncil® and Revascor®, will not be subject to the tariffs. Mesoblast develops allogeneic products based on its proprietary remestemcel-L and rexlemestrocel-L mesenchymal lineage stromal and precursor cell platform technologies. Its allogeneic cellular products derived from these platforms are manufactured from U.S. donors in the U.S.
NEW YORK, April 02, 2025 (GLOBE NEWSWIRE) -- Mesoblast (NASDAQ:MESO, ASX:MSB)), global leader in allogeneic cellular medicines for inflammatory diseases, today provided an update on its plans to meet with the United States Food and Drug Administration (FDA) to discuss the accelerated approval pathway for Revascor® (rexlemestrocel-L) in the treatment of patients with ischemic chronic heart failure with reduced ejection fraction (HFrEF) and inflammation. Mesoblast filed a request for a Type B meeting during the last quarter, in line with previous guidance, and expects to have the meeting during this quarter. The meeting will be held under Mesoblast's Regenerative Medicines Advanced Therap
NEW YORK, March 30, 2025 (GLOBE NEWSWIRE) -- Mesoblast (NASDAQ:MESO, ASX:MSB)), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that it has entered into the Medicaid National Drug Rebate Agreement (NDRA) with the U.S. Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services, for Ryoncil® (remestemcel-L), the first mesenchymal stromal cell (MSC) therapy approved by U.S. Food and Drug Administration (FDA) for any indication. The NDRA agreement with Mesoblast means that the U.S. Government now provides inpatient and outpatient access for a treatment course of Ryoncil® to the approximately 40% of U.S. children covered by
NEW YORK, March 26, 2025 (GLOBE NEWSWIRE) -- Mesoblast Limited (NASDAQ:MESO, ASX:MSB)), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that Ryoncil® (remestemcel-L) the first mesenchymal stromal cell (MSC) therapy approved by U.S. Food and Drug Administration (FDA) for any indication, is now available for purchase in the United States. Ryoncil® is approved for treatment of pediatric patients 2 months and older, including adolescents and teenagers, with steroid-refractory acute graft versus host disease (SR-aGvHD), a condition with high mortality rates. The recommended dosage of Ryoncil® for treatment of pediatric SR-aGvHD is 2×106 MSC/kg body w
NEW YORK, March 13, 2025 (GLOBE NEWSWIRE) -- Mesoblast Limited (NASDAQ:MESO, ASX:MSB)), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that pricing information for Ryoncil® is now available in all four major drug pricing compendia in the United States. These pricing compendia provide the official source for all information required to order product, including product manufacturing details, National Drug Codes (NDC) for kit purchase, and kit pricing. The pricing compendia listing followed approval and publication by the U.S. Food and Drug Administration (FDA) of the revised Ryoncil® label, which includes revisions to Section 16 (How Supplied / Sto
NEW YORK, March 12, 2025 (GLOBE NEWSWIRE) -- Mesoblast Limited (NASDAQ:MESO, ASX:MSB)), global leader in allogeneic cellular medicines for inflammatory diseases, announced today that Chief Executive Silviu Itescu will deliver the Featured Presentation at the International Cell & Gene Therapy (ISCT) North America Regional Virtual Town Hall at 4.00pm EDT, Wednesday, March 12th; 7.00am AEDT, Thursday, March 13th, 2025. The presentation, titled "Ryoncil® - The First FDA Approved Mesenchymal Stromal Cell Therapy," can be accessed via: https://www.isctglobal.org/town-hall/north-america-march-2025 About Mesoblast Mesoblast (the Company) is a world leader in developing allogeneic (off-the-shelf)
Jefferies downgraded Mesoblast from Buy to Hold
Maxim Group upgraded Mesoblast from Hold to Buy and set a new price target of $12.00
Jefferies upgraded Mesoblast from Hold to Buy
Piper Sandler upgraded Mesoblast from Neutral to Overweight and set a new price target of $11.00 from $4.00 previously
Jefferies upgraded Mesoblast from Hold to Buy
Maxim Group downgraded Mesoblast from Buy to Hold
Piper Sandler downgraded Mesoblast from Overweight to Neutral and set a new price target of $2.00 from $7.00 previously
William Blair downgraded Mesoblast from Outperform to Mkt Perform
William Blair initiated coverage of Mesoblast with a rating of Outperform and set a new price target of $8.00
Jefferies downgraded Mesoblast from Buy to Hold
NEW YORK, April 29, 2025 (GLOBE NEWSWIRE) -- Mesoblast Limited (NASDAQ:MESO, ASX:MSB)), global leader in allogeneic cellular medicines for inflammatory diseases, today provided highlights of its recent activities for the third quarter ended March 31, 2025. "We were very pleased to have made Ryoncil® (remestemcel-L) commercially available to treat children with acute GVHD within one quarter of receiving FDA approval as the first mesenchymal stromal cell (MSC) therapy approved in the US for any indication," said Dr. Silviu Itescu, CEO of Mesoblast. "With our strong cash position we are well placed to expand Ryoncil® indications to other serious and life-threatening pediatric inflammatory di
NEW YORK, April 28, 2025 (GLOBE NEWSWIRE) -- Mesoblast (NASDAQ:MESO, ASX:MSB)), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that it has appointed Lyn Cobley to its Board of Directors. Ms. Cobley has been a global leader in the financial services industry with over 30 years' experience in senior positions at international and domestic banks. Ms. Cobley has served as CEO of Westpac Institutional Bank, Group Treasurer of Commonwealth Bank of Australia, and held senior roles at Barclays Capital and Citibank Limited. Ms. Cobley is currently a director of Commonwealth Bank of Australia, is a member of Chief Executive Women, a member of the Macquarie
NEW YORK, Feb. 23, 2025 (GLOBE NEWSWIRE) -- Mesoblast Limited (NASDAQ:MESO, ASX:MSB)), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that it has appointed Dr. Gregory George MD PhD, Mesoblast's largest shareholder, to its Board of Directors. Dr. George founded and managed the largest privately owned ambulatory surgical center company in the United States, SurgCenter Development. Dr. George brings to the Board his background as a medical scientist with unique operational experience having built a start-up company in the medical field and turning it into a highly-efficient multi-billion-dollar commercial organization. Mesoblast Founder and Chief
KaliVir Immunotherapeutics, Inc., a biotech company developing cutting-edge, multi-mechanistic oncolytic viral immunotherapy programs, today announces the appointment of Schond Greenway as Chief Financial Officer (CFO). With more than 25 years of experience in corporate finance and investment analysis, Mr. Greenway has extensive biotechnology expertise, notably in navigating capital markets and spearheading successful fundraising initiatives. "We are thrilled to welcome Schond as our inaugural CFO. As we advance into clinical development with our lead program VET3-TGI, his proven track record in biotech finance and strategic leadership will be pivotal in steering KaliVir through our next
Dr. Grossman brings over 20 years of drug development expertise having held senior executive leadership positions in large and small pharmaceutical companies leading the development and FDA approval of numerous multi-billion dollar blockbuster drugs addressing significant unmet medical needs particularly across CNS disorders. Dr. Grossman held executive positions at Eli Lilly, Johnson & Johnson, Bristol Myers Squibb, and Sunovion. He served as President and Chief Medical Officer at Glenmark Pharmaceuticals (BSE: 532296) as well as Chief Medical Officer at Mesoblast, Inc. (NASDAQ:MESO). Dr. Grossman is Board-Certified in Psychiatry and a Fellow of the American Psychiatric Association
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. Ms Bell curre
NEW YORK, Feb. 01, 2022 (GLOBE NEWSWIRE) -- Mesoblast Limited (NASDAQ:MESO), 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
Imvax, a clinical-stage biotechnology company developing personalized, whole tumor-derived immunotherapies, announced the appointment of Josh Muntner as the company's chief financial officer effective August 31, 2021. "We are proud to further bolster our leadership team with the appointment of Josh, who brings to Imvax significant expertise in areas of capital markets and fundraising which will be instrumental to our continued trajectory of growth," said John P. Furey, CEO of Imvax. "I also want to express my profound thanks to Art Howe, co-founder of Imvax and outgoing CFO, for his tireless efforts building the company over the years. We are at a point of exciting momentum as we progress
NEW YORK, Aug. 28, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (NASDAQ:MESO, ASX:MSB))), global leader in allogeneic cellular medicines for inflammatory diseases, today provided an operational update and reported financial results for the period ended June 30, 2024. Mesoblast Chief Executive Silviu Itescu said: "During the past year we have built significant momentum in our interactions with the United States Food and Drug Administration (FDA) across each of our Phase 3 products. I am very pleased that our Biologics License Application (BLA) resubmission for approval of Ryoncil® (remestemcel-L) in the treatment of children with steroid-refractory acute graft versus host disease (SR-aGVHD)
NEW YORK, Feb. 28, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (NASDAQ:MESO, ASX:MSB))), global leader in allogeneic cellular medicines for inflammatory diseases, today provided an operational update and reported financial results for the period ended December 31, 2023. Mesoblast Chief Executive Silviu Itescu said: "We were very busy operationally during the last quarter and continued to have positive engagement with the United States Food and Drug Administration (FDA) across our lead programs. We have strengthened our balance sheet while maintaining overall spending constraint in line with our corporate objectives. For our product Ryoncil® (remestemcel-L) for life-threatening steroid-ref
NEW YORK, Aug. 30, 2023 (GLOBE NEWSWIRE) -- Mesoblast Limited (NASDAQ:MESO, ASX:MSB))), global leader in allogeneic cellular medicines for inflammatory diseases, today reported financial results and an operational update for the period ended June 30, 2023, and provided an overview of upcoming milestones. Mesoblast Chief Executive Silviu Itescu said: "We had anticipated that remestemcel-L would have been approved by the United States Food and Drug Administration (FDA) for the treatment of pediatric steroid-refractory acute graft versus host disease (SR-aGVHD), a condition with a high mortality where there are no approved therapies for children under 12 years old. During the six-month B
NEW YORK, Aug. 03, 2023 (GLOBE NEWSWIRE) -- Mesoblast Limited (NASDAQ:MESO, ASX:MSB))), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that the US Food and Drug Administration (FDA) has provided a complete response to its Biologics License Application (BLA) resubmission for remestemcel-L for the treatment of pediatric steroid-refractory acute graft versus host disease (SR-aGVHD) and requires more data to support marketing approval. To obtain the data required, Mesoblast will conduct a targeted, controlled study in the highest-risk adults with the greatest mortality. This adult study is in line with our overall commercial strategy, which envisioned
NEW YORK, May 25, 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 March 31, 2023. OPERATIONAL HIGHLIGHTS Remestemcel-L BLA filing accepted by FDA, PDUFA goal date set US Food and Drug Administration (FDA) accepted Mesoblast's filing of the Biologics License Application (BLA) for remestemcel-L in the treatment of children with steroid-refractory graft versus host disease (SR-aGVHD) as being complete and has set a Prescription Drug User Fee Act (PDUFA) goal date of August 2, 2023. FDA pre-license i
Durable long-term survival outcomes through 4 years for children with steroid-refractory graft versus host disease (SR-aGVHD) treated with remestemcel-L These long-term survival outcomes are a cornerstone of the BLA resubmission to FDA for approval of remestemcel-L in the treatment of children with SR-aGVHD NEW YORK, Nov. 22, 2022 (GLOBE NEWSWIRE) -- Mesoblast Limited ((ASX:MSB, NASDAQ:MESO), global leader in allogeneic cellular medicines for inflammatory diseases, today reported operational highlights and financial results for the period ended September 30, 2022 and provided an update on upcoming milestones. "The substantial and durable long-term survival over four years we
At June 30, 2022, cash-on-hand was US$60.4 million with pro-forma US$105.5 million after raising gross proceeds of US$45 million via a private placement in August, 2022 Up to an additional US$40 million available from existing facilities subject to certain milestonesNet operating spend of US$65.8 million for the 12 months ended June 2022, a 35% reduction on comparative year, with continued focus on cost controlBLA resubmission for remestemcel-L in children with SR-aGVHD expected to be filed this quarter, with potential US approval Q1 CY2023Plan to meet with FDA next quarter under existing regenerative medicine advanced therapy (RMAT) designation to discuss common mechanism of action in HFrEF
NEW YORK, May 31, 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 March 31, 2022. Financial Highlights Net cash usage reported for operating activities in the quarter was reduced by 40%, or US$10.3 million, to US$15.5 million compared with US$25.8 million in the comparative quarter last year1For the quarter, net cash usage reported for operating activities, excluding inventory for the planned remestemcel-L product launch, was reduced by 50% to US$11.2 million from US$22.2 million in the comparative quarterFor the n
NEW YORK, Feb. 24, 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 December 31, 2021. Financial Highlights Mesoblast completed a refinancing of its senior secured debt facility with a new US$90 million five-year facility provided by funds managed by Oaktree Capital Management, L.P. Cash on hand at the end of the quarter was US$94.8 million, with up to an additional US$40 million available to be drawn down from existing financing facilities subject to certain milestonesTotal Operating Activities saw a 40% reduction
NEW YORK, Nov. 23, 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 first quarter ended September 30, 2021. "We are pleased to have entered into a strategic financing partnership with leading global investment management firm Oaktree Capital as we focus on bringing our first product to the US market and in line with our commercial growth strategy over the next five years," said Silviu Itescu, Chief Executive of Mesoblast" Financial & Operational Highlights Successfully entered into a refinancing and expansion of our
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