reports
Mesoblast Ltd: 1 director
A director at Mesoblast Ltd bought 303,100 shares at 1.670USD and the significance rating of the trade was 68/100. Is that information sufficient for you to make an investment decision? This report gives details of those trades and adds context and analysis to them such that you can judge whether these trading decisions are ones worth following. Included in the report is a detailed share price chart which plots discretionary trades by all the company's directors over the last two years clearly...
Mesoblast’s RYONCIL® is the First U.S. FDA-Approved Mesenchymal Stroma...
Mesoblast’s RYONCIL® is the First U.S. FDA-Approved Mesenchymal Stromal Cell (MSC) Therapy 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 treatm...
Mesoblast to be Added to Nasdaq Biotechnology Index
Mesoblast to be Added to Nasdaq Biotechnology Index 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 according to the Industry Classif...
FDA Grants Revascor® (Rexlemestrocel-L) Regenerative Medicine Advanced...
FDA Grants Revascor® (Rexlemestrocel-L) Regenerative Medicine Advanced Therapy (RMAT) Designation in Children with Congenital Heart Disease Earlier this year FDA granted REVASCOR both Rare Pediatric Disease Designation (RPDD) and Orphan-Drug Designation (ODD) for congenital heart disease NEW YORK, Dec. 04, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced the United States Food and Drug Administration (FDA) has granted its second generation allogeneic, STRO3-immunoselected, and ind...
Revascor Improves Survival and Reduces Major Morbidity in High-Risk Is...
Revascor Improves Survival and Reduces Major Morbidity in High-Risk Ischemic Heart Failure Patients With Inflammation Phase 3 trial results published in European Journal of Heart Failure identify key target population for Mesoblast allogeneic cell therapy 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 intram...
Appendix 4C Quarterly Activity Report for Quarter Ended September 30, ...
Appendix 4C Quarterly Activity Report for Quarter Ended September 30, 2024 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 ap...
Mesoblast Option to Issue Up to US$50 Million Convertible Notes for Pr...
Mesoblast Option to Issue Up to US$50 Million Convertible Notes for Product Launch 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...
Mesoblast Reports Financial Results and Operational Update for Fiscal ...
Mesoblast Reports Financial Results and Operational Update for Fiscal Year Ended June 30, 2024 Potential first product approval and preparing for commercial launch 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 Admi...
Mesoblast Financial Results and Corporate Update Webcast
Mesoblast Financial Results and Corporate Update Webcast NEW YORK, Aug. 27, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, will host a webcast to discuss operational highlights and financial results for the full year ended June 30, 2024. The webcast will begin at 6.30pm EDT, Wednesday, August 28; 8.30am AEST, Thursday, August 29, 2024. It can be accessed via: The archived webcast will be available on the Investor page of the Company’s website: About Mesoblast Mesoblast (the...
Appendix 4C Quarterly Activity Report for Quarter Ended June 30, 2024
Appendix 4C Quarterly Activity Report for Quarter Ended June 30, 2024 Ryoncil BLA Submission Under FDA Review for Approval in Children with SR-aGVHD NEW YORK, July 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 fourth quarter ended June 30, 2024. Mesoblast Chief Executive Silviu Itescu said: “We are very pleased with the strong relationship we have built with FDA across our product pipeline and the positive outcomes over the past s...
FDA Accepts Mesoblast’s Biologics License Application (BLA) for Ryonci...
FDA Accepts Mesoblast’s Biologics License Application (BLA) for Ryoncil® in Children With Steroid-Refractory Acute Graft-Versus-Host Disease (SR-aGVHD) If Approved, RYONCIL will be the First Allogeneic “Off-the-Shelf” Cellular Medicine in the US, and the First Cell Therapy for Children Up To 18 Years Old with SR-aGVHD NEW YORK, July 23, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, announced that the United States Food and Drug Administration (FDA) has accepted its Biologics License Applicati...
Patient Enrollment Commenced in Pivotal Phase 3 Trial of Rexlemestroce...
Patient Enrollment Commenced in Pivotal Phase 3 Trial of Rexlemestrocel-L for Chronic Low Back Pain NEW YORK, July 21, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, announced today that the confirmatory Phase 3 trial of its allogeneic, immunoselected, and industrially manufactured stromal cell product rexlemestrocel-L in patients with chronic low back pain (CLBP) due to inflammatory degenerative disc disease of less than five years duration has commenced enrollment at multiple sites across the U...
Mesoblast Resubmits Biologics License Application (BLA) with United St...
Mesoblast Resubmits Biologics License Application (BLA) with United States Food & Drug Administration (FDA) for Approval of Ryoncil® in Children with Steroid-Refractory Acute Graft-Versus-Host Disease (SR-aGVHD) NEW YORK, July 08, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, announced today it has resubmitted its BLA for approval of Ryoncil® (remestemcel-L) in the treatment of children with SR-aGVHD. The filing comes after Mesoblast was informed by FDA at the end of March that, following addit...
Mesoblast to File Biologics License Application for Ryoncil® FDA Appro...
Mesoblast to File Biologics License Application for Ryoncil® FDA Approval Next Week NEW YORK, July 01, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today confirmed that it will file its Biologics License Application (BLA) for approval of Ryoncil® (remestemcel-L) in the treatment of children with steroid-refractory acute graft versus host disease (SR-aGVHD) with the U.S. Food and Drug Administration (FDA) next week. About Mesoblast Mesoblast (the Company) is a world leader in developing allog...
Mesoblast Corporate Presentation at Investor Conference
Mesoblast Corporate Presentation at Investor Conference NEW YORK, June 02, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), Chief Executive Silviu Itescu provided a corporate update at the Bell Potter Emerging Leaders Conference. Dr. Itescu reiterated that the Company expects to file this quarter the Biologics License Application (BLA) resubmission with the United States Food and Drug Administration (FDA) for its lead product candidate Ryoncil®(remestemcel-L) in the treatment of steroid-refractory acute graft versus host disease, with potential approval in the second ha...
Appendix 4c Quarterly Activity Report for Quarter Ended March 31, 2024
Appendix 4c Quarterly Activity Report for Quarter Ended March 31, 2024 FDA Provides Clarity on Path to Licensure for Remestemcel-L in SR-aGVHD and Rexlemestrocel-L in End-Stage Heart Failure NEW YORK, April 29, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided an activity report for the third quarter ended March 31, 2024. Mesoblast Chief Executive Silviu Itescu said: “We are very pleased with the positive interactions we had last quarter with the FDA, having received clarity on the...
United States Food & Drug Administration (FDA) Notifies Mesoblast that...
United States Food & Drug Administration (FDA) Notifies Mesoblast that Available Clinical Data from Phase 3 Trial Appear Sufficient to Support BLA Submission for Remestemcel-L in Children with Steroid-Refractory Acute Graft Versus Host Disease (SR-aGVHD) NEW YORK, March 25, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that U.S. FDA has informed the company that following additional consideration the available clinical data from its Phase 3 study MSB-GVHD001 appears sufficient to...
Mesoblast Successfully Completes Placement and Accelerated Entitlement...
Mesoblast Successfully Completes Placement and Accelerated Entitlement Offer NEW YORK, March 13, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced it has received firm commitments to complete its pro-rata accelerated non-renounceable entitlement offer that was launched on 4 December, 2023 (Entitlement Offer). Together the entitlement offer and institutional placement raised gross proceeds of A$97 million, including A$36.7 million committed today on the same terms as the Entitlement O...
United States Food & Drug Administration (FDA) Supports Accelerated Ap...
United States Food & Drug Administration (FDA) Supports Accelerated Approval Pathway for Rexlemestrocel-L in End-Stage Heart Failure Patients with a Left Ventricular Assist Device (LVAD) NEW YORK, March 10, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that U.S. FDA supports an accelerated approval pathway for rexlemestrocel-L, Mesoblast’s allogeneic mesenchymal precursor cell (MPC) product, in patients with end-stage ischemic heart failure with reduced ejection fraction (HFrEF) ...
Mesoblast Reports Financial Results and Operational Update for Half-Ye...
Mesoblast Reports Financial Results and Operational Update for Half-Year Ended December 31, 2023 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. ...
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