Shares of Mesoblast Limited (MESO) have soared 80% in one month following the FDA approval of remestemcel-L as the only approved therapy for steroid-refractory acute graft versus host disease (SR-aGVHD) in children aged two months and older, including adolescents and teenagers. The drug has a novel mechanism of action and will be marketed under the brand name Ryoncil in the United States.The approval gave Mesoblast its first approved product in its portfolio. Sales of the drug are expected to provide the co ...

Mesoblast Limited (MESO) announced that the FDA has approved Ryoncil (remestemcel-L) for the treatment of steroid-refractory acute graft versus host disease (SR-aGvHD) in children aged two months and older, including adolescents and teenagers.Following the FDA nod, Ryoncil became the first and only mesenchymal stromal cell therapy to be approved for any indication in the United States.Ryoncil is also the first FDA-approved therapy for pediatric SR-aGvHD, a life-threatening condition with high mortality rate ...

On Wednesday, the FDA approved Mesoblast Limited’s MESO Ryoncil (remestemcel-L) as the first mesenchymal stromal cell (MSC) therapy in the U.S.Ryoncil is the only MSC therapy approved in the U.S. for any indication and the only therapy for steroid-refractory acute graft versus host disease (SR-aGvHD) in children 2 months and older, including adolescents.Ryoncil contains MSCs, a type of cell that can have various roles in the body and can differentiate into multiple other types of cells. These MSCs are isola ...

RYONCIL (remestemcel-L) is the first MSC product approved by FDA for any indication.RYONCIL is the first FDA-approved therapy for children aged 2 months and older, including adolescents and teenagers, with steroid-refractory acute graft versus host disease (SR-aGvHD), a life-threatening condition with high mortality rates.In a single-arm, multi-center, Phase 3 trial of children with SR-aGvHD, 89% of whom had high severity Grade C or Grade D disease, 70% achieved an overall response by Day 28 of treatment wi ...

NEW YORK, Dec. 18, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (NASDAQ:MESO, ASX:MSB)), global leader in allogeneic cellular medicines for inflammatory diseases, today announced its upcoming addition to the Nasdaq Biotechnology Index (NASDAQ:NBI) as part of the annual reconstitution of the 2024 Nasdaq index. Mesoblast's inclusion in the NBI will be effective after the U.S. market opens on Monday, December 23, 2024. The Nasdaq Biotechnology Index contains securities of Nasdaq-listed companies classified accor ...

NEW YORK, Dec. 02, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced a key publication in the November 2024 online issue of the prestigious peer-reviewed European Journal of Heart Failure (EJHF), which reports that a single intramyocardial injection of the Company’s allogeneic cell therapy Revascor® (rexlemestrocel-L) results in improved survival in high-risk patients with ischemic heart failure and in ...

NEW YORK, Oct. 30, 2024 (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 first quarter ended September 30, 2024. Mesoblast Chief Executive Silviu Itescu said: "We have had an extremely busy and productive quarter starting right from the outset with the filing of our Biologics License Application (BLA) with the United States Food and Drug Administration (FDA) for a ...

NEW YORK, Sept. 29, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced it has entered into a convertible note subscription agreement with its largest shareholder Gregory George ("Investor") for issue, at its sole discretion, up to US$50.0 million (A$72.7 million) convertible notes on approval by the United States Food and Drug Administration (FDA) of Mesoblast's lead product candidate Ryoncil® (remestem ...

mesol CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS This presentation includes forward-looking statements that relate to future financial performance and involve known and unknown risks, uncertainties and results. levels of activity, performance or achievements to differ materially from any future results. Ievels of activity, performance or achievements expressed or implied such forward- tooking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 ______________________________ FORM 20-F ______________________________ o REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR x ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended June 30, 2024 OR o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 OR o SHELL COMPANY REPORT PUR ...