Mesoblast Limited
Level 1, 843A Glenhuntly Road
Caulfield South
VIC
3162
Tel: 03-9618-7000
280 articles with Mesoblast Limited
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Mesoblast Resubmits Biologic License Application (BLA) to FDA for Remestemcel-L in Children With Steroid-Refractory Acute Graft Versus Host Disease (Sr-aGVHD)
1/31/2023
Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, announced today it has resubmitted to the U.S. Food and Drug Administration (FDA) its Biologics License Application (BLA) for approval of remestemcel-L in the treatment of children with steroid-refractory acute graft versus host disease (SR-aGVHD).
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Appendix 4C Quarterly Activity ReportMesoblast Operational and Financial Highlights for Quarter Ended December 31, 2022
1/31/2023
Mesoblast Limited, global leader in allogeneic cellular medicines for inflammatory diseases, provided an activity report for the second quarter ended December 31, 2022.
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Mesoblast and Oaktree Extend Availability Period of Undrawn Tranches of Financing Facility
12/23/2022
Mesoblast Limited announced that funds managed by Oaktree Capital Management, L.P. 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.
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Children Treated With Remestemcel-L Show Long-Term Survival Through Four Years in Steroid-Refractory Acute Graft Versus Host Disease (SR-aGVHD)
11/22/2022
Mesoblast Limited, global leader in allogeneic cellular medicines for inflammatory diseases, announced top-line long-term survival results for remestemcel-L from its pivotal Phase 3 trial in children with steroid-refractory acute graft-versus-host disease.
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Mesoblast Financial Results and Corporate Update Webcast - November 21, 2022
11/21/2022
Mesoblast Limited, global leader in allogeneic cellular medicines for inflammatory diseases, will host a webcast to discuss operational highlights and financial results for the first quarter ended September 30, 2022.
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Mesoblast Operational and Financial Highlights for Quarter Ended September 30, 2022
10/30/2022
Mesoblast Limited, global leader in allogeneic cellular medicines for inflammatory diseases, provided an activity report for the fourth quarter ended September 30, 2022.
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Mesoblast Submits New Information to FDA IND File in Response to Items in the CRL to the Remestemcel-L BLA for SR-aGVHD
10/2/2022
Mesoblast Limited announced that it has submitted to the U.S. Food and Drug Administration substantial new information on clinical and potency assay items identified in the Complete Response Letter received from FDA in September 2020 to the Biologics License Application for remestemcel-L in the treatment of children with steroid-refractory acute graft versus host disease.
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Mesoblast fell short of analyst forecasts this week, and money is pouring into glaucoma, medical devices for heart disease and chronic endocrine conditions.
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Mesoblast Corporate Update and Financial Results Webcast - Aug 30, 2022
8/30/2022
Mesoblast Limited, 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.
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Jane Bell Joins Mesoblast Board
8/18/2022
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.
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Mesoblast Key Opinion Leader Event Series for Investors & Analysts
6/9/2022
Mesoblast Limited, global leader in allogeneic cellular medicines for inflammatory diseases, will host a webinar focused on the current treatment landscape and unmet medical need for patients with chronic low back pain due to degenerative disc disease, a condition associated with local inflammation in the disc.
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Appendix 4C Quarterly Activity ReportMesoblast Operational and Financial Highlights for Quarter Ended March 31, 2022
4/29/2022
Mesoblast Limited, global leader in allogeneic cellular medicines for inflammatory diseases, provided an activity report for the third quarter ended March 31, 2022.
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Philip R. Krause, M.D., Former FDA Deputy Chief for Vaccines, Joins Mesoblast Board
3/24/2022
Mesoblast Limited, global leader in allogeneic cellular medicines for inflammatory diseases, announced that Philip R. Krause, M.D. has joined its Board of Directors.
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Mesoblast Corporate Update and Financial Results Webcast - Feb 24, 2022
2/24/2022
Mesoblast Limited, global leader in allogeneic cellular medicines for inflammatory diseases, will host a webcast to discuss operational highlights and financial results for the second quarter ended December 31, 2021.
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Rapid Improvement and Remission in Patients With Refractory Ulcerative Colitis and Crohn’s Colitis After Direct Injection of Remestemcel-L by Colonoscopy
2/20/2022
Mesoblast Limited, global leader in allogeneic cellular medicines for inflammatory diseases, announced positive results from an interim analysis of the first patient cohort in the randomized, controlled study of remestemcel-L by direct endoscopic delivery to areas of inflammation in patients with medically refractory ulcerative colitis or Crohn’s colitis.
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BioSpace Movers & Shakers, Feb. 4
2/4/2022
Biopharma and life sciences companies strengthen their boards and leadership teams with these Movers & Shakers. -
Appendix 4C Quarterly Activity ReportMesoblast Prepares for Resubmission of Biologics License Application
1/31/2022
Mesoblast Limited, global leader in allogeneic cellular medicines for inflammatory diseases, provided an operational and financial activity report for the second quarter ended December 31, 2021.
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Just as 2021 was wrapping up, the U.S. FDA had some end-of-year activity. Here’s a look.
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Biopharma and life sciences companies from across the globe provide updates on their businesses and pipelines.
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FDA’s OTAT in Agreement With 12-Month Reduction in Pain as Primary Endpoint for Chronic Low Back Pain Program
12/16/2021
Mesoblast Limited announced that it has received feedback from the US Food & Drug Administration’s Office of Tissues and Advanced Therapies on the Phase 3 program of rexlemestrocel-L in patients with chronic low back pain due to degenerative disc disease refractory to available therapies, including opioids.