{"filing":{"accession_number":"0001345099-26-000085","cik":"0001345099","ticker":"MEOBF","company_name":"MESOBLAST LTD","form":"6-K","filing_date":"2026-09-23","report_date":"2026-09-24","primary_document":"form6-kxpressreleasecoverf.htm","primary_document_url":"https://www.sec.gov/Archives/edgar/data/1345099/000134509926000085/form6-kxpressreleasecoverf.htm"},"events":[{"id":34687,"run_id":31931,"accession_number":"0001345099-26-000085","anchor_item_number":"EX-99.1","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"summary":"Mesoblast announced FDA approval to implement a new potency assay (TIBA) for release and stability monitoring of its commercial Ryoncil product. This is a material regulatory advancement affecting the company's manufacturing and quality control processes for its lead FDA-approved product, but it does not fit the specific event categories of earnings release, M\u0026A, executive changes, debt issuance, or other named types. The approval enhances product consistency and clinical effectiveness, making it operationally significant to a reasonable investor assessing the company's ability to commercialize and maintain Ryoncil.","company_name":"MESOBLAST LTD","ticker":"MEOBF","filing_date":"2026-09-23","form":"6-K","submitted_at":null,"items":[{"id":38502,"accession_number":"0001345099-26-000085","item_number":"EX-99.1","item_title":"exhibit991ryoncilpotency.htm","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"reasoning":"Mesoblast announced FDA approval to implement a new potency assay (TIBA) for release and stability monitoring of its commercial Ryoncil product. This is a material regulatory advancement affecting the company's manufacturing and quality control processes for its lead FDA-approved product, but it does not fit the specific event categories of earnings release, M\u0026A, executive changes, debt issuance, or other named types. The approval enhances product consistency and clinical effectiveness, making it operationally significant to a reasonable investor assessing the company's ability to commercialize and maintain Ryoncil.","classifier_version":"claude-haiku-4-5-20251001+prompt-6be895f9","taxonomy_version":"v1.3","classified_at":"2026-09-24T10:03:48.997266+00:00","company_name":"","ticker":null,"filing_date":""}]}],"classifications":[{"id":38502,"accession_number":"0001345099-26-000085","item_number":"EX-99.1","item_title":"exhibit991ryoncilpotency.htm","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"reasoning":"Mesoblast announced FDA approval to implement a new potency assay (TIBA) for release and stability monitoring of its commercial Ryoncil product. This is a material regulatory advancement affecting the company's manufacturing and quality control processes for its lead FDA-approved product, but it does not fit the specific event categories of earnings release, M\u0026A, executive changes, debt issuance, or other named types. The approval enhances product consistency and clinical effectiveness, making it operationally significant to a reasonable investor assessing the company's ability to commercialize and maintain Ryoncil.","classifier_version":"claude-haiku-4-5-20251001+prompt-6be895f9","taxonomy_version":"v1.3","classified_at":"2026-09-24T10:03:48.997266+00:00","company_name":"MESOBLAST LTD","ticker":"MEOBF","filing_date":"2026-09-23"}]}