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MESOBLAST LTD — Investor Relations & Filings

Ticker · MESO ISIN · US5907171046 ASX Manufacturing
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Filings indexed 2,013 across all filing types
Latest filing 2023-02-08 Regulatory Filings
Country US United States of America
Listing ASX MESO

About MESOBLAST LTD

https://www.mesoblast.com/

Mesoblast is a regenerative medicine company that develops allogeneic (off-the-shelf) cellular medicines for severe and life-threatening inflammatory conditions. The company utilizes its proprietary mesenchymal lineage cell (MSC) technology platform to create treatments for inflammatory ailments, cardiovascular disease, and chronic back pain. The technology sources rare MSCs from the bone marrow of healthy adult donors, which are then expanded using proprietary processes for industrial-scale manufacturing. A key feature of these cells is their ability to be administered without donor-recipient matching or immune suppression. The therapeutic candidates are designed to respond to tissue damage by secreting mediators that promote tissue repair and modulate immune responses. The company's late-stage portfolio includes remestemcel-L for acute graft versus host disease (GVHD) and acute respiratory distress syndrome (ARDS), REVASCOR® for advanced chronic heart failure, and MPC-06-ID for chronic low back pain.

Recent filings

Filing Released Lang Actions
FDA Grants RMAT Designation for Rexlemestrocel-L in CLBP 3 pages 184.6KB
Regulatory Filings Classification · 95% confidence The document is a press release announcing that the FDA has granted Regenerative Medicine Advanced Therapy (RMAT) designation for Mesoblast's product rexlemestrocel-L for chronic low back pain. It discusses the clinical trial results, the significance of the designation, and provides background on the company and the condition treated. There are no financial statements, no detailed financial performance data, no regulatory filings or certifications, and no mention of shareholder votes or management changes. The document is an announcement of a regulatory milestone and clinical development update rather than a formal financial or regulatory filing. It is not a report publication announcement since it does not mention the release or availability of a report, nor is it a certification or legal proceeding update. The content fits best under Regulatory Filings (RNS) as a general regulatory announcement and company update that does not fit other specific categories.
2023-02-08 English
REPORT OF FOREIGN PRIVATE ISSUER
Regulatory Filings
2023-02-01 English
Mesoblast Completes Resubmission of BLA to FDA for SR-aGVHD 4 pages 192.3KB
Regulatory Filings Classification · 95% confidence The document is a press release announcing the resubmission of a Biologics License Application (BLA) to the FDA for a drug candidate, remestemcel-L, for treatment of steroid-refractory acute graft versus host disease in children. It contains detailed information about the clinical trial data, regulatory designations (Fast Track, Priority Review), and the FDA review process timeline. The document is not a full regulatory filing or report but an announcement of a regulatory submission and related clinical data updates. It does not contain comprehensive financial statements or detailed management discussion typical of annual or interim reports. It is also not a transcript, audit report, or other specific filing type. Given the nature of the content as a regulatory update and announcement, the best fitting category is Regulatory Filings (RNS), which serves as a fallback for miscellaneous regulatory announcements that do not fit other categories. The document length (15,000 characters) and detailed content support this classification with high confidence.
2023-01-31 English
Quarterly Activities/Appendix 4C Cash Flow Report 10 pages 395.6KB
Interim / Quarterly Report Classification · 95% confidence The document is titled 'APPENDIX 4C QUARTERLY ACTIVITY REPORT' and provides detailed financial and operational highlights for the quarter ended December 31, 2022. It includes comprehensive financial data such as revenue, net cash usage, cash on hand, and detailed cash flow statements (operating, investing, and financing activities). The document also discusses operational updates, clinical trial progress, and regulatory interactions. The presence of detailed financial statements and analysis for a quarter, along with the Appendix 4C cash flow report, indicates this is a comprehensive interim financial report for a period shorter than a full fiscal year. The document is about 15,000 characters long, which is substantial and contains actual financial data, not just an announcement or certification. Therefore, it fits the definition of an Interim / Quarterly Report (IR).
2023-01-30 English
MESOBLAST LIMITED
Major Shareholding Notification
2023-01-20 English
6-K
Regulatory Filings
2023-01-18 English

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