reports
Mesoblast Ltd: 1 director
A director at Mesoblast Ltd maiden bought 21,428 shares at 6.642USD and the significance rating of the trade was 76/100. 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 c...
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. ...
Mesoblast Financial Results and Corporate Update Webcast
Mesoblast Financial Results and Corporate Update Webcast NEW YORK, Feb. 26, 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 six months ended December 31, 2023. The webcast will begin at 5.00pm EST, Wednesday, February 28; 9.00am AEDT, Thursday, February 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 is a wo...
United States Food & Drug Administration (FDA) Grants Mesoblast Orphan...
United States Food & Drug Administration (FDA) Grants Mesoblast Orphan-Drug Designation for Revascor® (Rexlemestrocel-L) in Children With Congenital Heart Disease NEW YORK, Feb. 14, 2024 (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 (FDA) has granted its allogeneic cell therapy Revascor® (rexlemestrocel-L) an Orphan-Drug Designation (ODD) following submission of results from the randomized controlled trial in children with hypoplasti...
Appendix 4C Quarterly Activity Report for Quarter Ended December 31, 2...
Appendix 4C Quarterly Activity Report for Quarter Ended December 31, 2023 NEW YORK, Jan. 30, 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 second quarter ended December 31, 2023. Mesoblast Chief Executive Silviu Itescu said: “It has been a very busy quarter in which we have made substantial operational progress across our three lead Phase 3 assets. We have generated significant new potency and characterization data for our lead product Ryoncil...
United States Food & Drug Administration (FDA) Grants Mesoblast Rare P...
United States Food & Drug Administration (FDA) Grants Mesoblast Rare Pediatric Disease Designation for Revascor® (Rexlemestrocel-L) in Children With Congenital Heart Disease REVASCOR Increases Size of Left Heart Chamber and Improves Surgical Outcomes in Children with Hypoplastic Left Heart Syndrome: Results Published in Journal of Thoracic and Cardiovascular Surgery Open NEW YORK, Jan. 18, 2024 (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 Adminis...
Mesoblast Files for Orphan Drug and Pediatric Rare Disease Designation...
Mesoblast Files for Orphan Drug and Pediatric Rare Disease Designations for Rexlemestrocel-L as Treatment for Severe Congenital Heart Disease NEW YORK, Nov. 26, 2023 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that it has filed for orphan drug designation (ODD) and rare pediatric disease designation (RPDD) with the United States Food and Drug Administration (FDA) for its allogeneic cell therapy Revascor® (rexlemestrocel-L) in the treatment of the congenital heart disease hypoplastic...
Mesoblast Partners With Blood and Marrow Transplant Clinical Trials Ne...
Mesoblast Partners With Blood and Marrow Transplant Clinical Trials Network (BMT CTN) on Pivotal Trial in Adults With SR-aGVHD NEW YORK, Nov. 21, 2023 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that the Blood and Marrow Transplant Clinical Trials Network (BMT CTN), a body including centers responsible for approximately 80% of all US allogeneic BMTs, has entered into an agreement to develop a pivotal trial of Mesoblast’s lead product candidate Ryoncil® (remestemcel-L) in the treatme...
Appendix 4C Quarterly Activity Report for Quarter Ended September 30, ...
Appendix 4C Quarterly Activity Report for Quarter Ended September 30, 2023 NEW YORK, Oct. 30, 2023 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided an activity report for the first quarter ended September 30, 2023. Mesoblast Chief Executive Silviu Itescu said: “During the period we had a very productive meeting with the United States Food and Drug Administration (FDA), which has allowed us to establish the path forward for potential pediatric and adult approvals of Ryoncil® (remestemce...
Key Outcomes From FDA Type A Meeting and Mesoblast Next Steps to Achie...
Key Outcomes From FDA Type A Meeting and Mesoblast Next Steps to Achieve RYONCIL Approval NEW YORK, Sept. 21, 2023 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided an update on the path to approval for its lead-product candidate remestemcel-L in the treatment of pediatric and adult steroid-refractory acute graft versus host disease (SR-aGVHD), following a Type A meeting held with the United States Food and Drug Administration (FDA). FDA clarified that the key remaining issue for pediatric...
Mesoblast Reports Financial Results and Operational Update for Fiscal ...
Mesoblast Reports Financial Results and Operational Update for Fiscal Year Ended June 30, 2023 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 pedi...
Mesoblast Financial Results and Corporate Update Webcast
Mesoblast Financial Results and Corporate Update Webcast NEW YORK, Aug. 29, 2023 (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 fourth quarter and full year ended June 30, 2023. The webcast will begin at 6.30pm EDT, Wednesday, August 30; 8.30am AEST, Thursday, August 31, 2023. It can be accessed via: The archived webcast will be available on the Investor page of the Company’s website: About Mesoblast Mesoblast is ...
Mesoblast Receives Complete Response From U.S. Food and Drug Administr...
Mesoblast Receives Complete Response From U.S. Food and Drug Administration for Biologics License Application for Steroid-Refractory Acute Graft Versus Host Disease in Children 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-aG...
Appendix 4C Quarterly Activity Report for Quarter Ended June 30, 2023
Appendix 4C Quarterly Activity Report for Quarter Ended June 30, 2023 NEW YORK, July 30, 2023 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided an activity report for the fourth quarter ended June 30, 2023. Activities Report Cash balance at the end of the quarter was US$71.3 million, with up to an additional US$40 million available to be drawn down from existing financing facilities subject to certain milestones.Revenue from royalties on sales of TEMCELL® HS Inj.1 sold in Japan by our l...
Mesoblast Director Philip R. Krause, M.D., Appointed to Strategic Advi...
Mesoblast Director Philip R. Krause, M.D., Appointed to Strategic Advisory Role NEW YORK, June 04, 2023 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, is pleased to announce that it has appointed Dr. Philip R. Krause, a member of the Board of Directors, to a formal strategic advisory role. Dr. Krause was formerly Deputy Director of the Office of Vaccines Research and Review at the US Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) and is an internationally recogn...
Mesoblast Reports Operational and Financial Highlights for Quarter End...
Mesoblast Reports Operational and Financial Highlights for Quarter Ended March 31, 2023 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 chi...
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