{"success":true,"data":{"pressRelease":{"id":"12011","rtpr_id":"nGNX1Kzpj9","ticker":"MSB","exchange":"ASX","all_tickers":["MSB"],"title":"Mesoblast Achieves Patient Recruitment Target in Pivotal Phase 3 Trial for Chronic Low Back Pain ","author":"Globe Newswire","published_at":"2026-04-29T00:53:16.107Z","article_body":"NEW YORK, April 28, 2026 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO;\nASX:MSB), global leader in allogeneic cellular medicines for inflammatory\ndiseases, today announced that its pivotal Phase 3 clinical trial evaluating\nrexlemestrocel-L for the treatment of chronic low back pain (CLBP) associated\nwith degenerative disc disease has achieved its patient recruitment target.\nThis marks a significant milestone in Mesoblast’s plans for\ncommercialization of rexlemestrocel-L, its proprietary allogeneic stromal cell\ntherapy targeting inflammatory processes underlying disc degeneration.\n\nThe placebo-controlled study (MSB-DR004) will follow at least 300 patients\nrandomized to a single intra-discal injection of rexlemestrocel-L or sham\ncontrol for 12 months. The trial seeks to confirm results from the earlier\nMSB-DR003 trial where a single intra-discal injection of rexlemestrocel-L\nresulted in clinically meaningful reductions in pain and opioid usage for up\nto three years.\n\nThe trial’s primary endpoint is powered to show a significant difference in\nreduction of low back pain at 12 months between rexlemestrocel-L and sham\ncontrols. Secondary endpoints include improvements in function, quality of\nlife, and cessation of pain medication, including opioids.\n\nTop-line results are expected in mid-CY2027 after the last randomized patient\nhas completed follow-up. A positive readout will be used in support of an\nexpected regulatory filing in Q3 CY2027 for United States Food and Drug\nAdministration (FDA) approval. Rexlemestrocel-L has Regenerative Medicine\nAdvanced Therapy (RMAT) designation from the FDA for treatment of CLBP due to\ndegenerative disc disease providing eligibility for priority review once the\nBiologics License Application (BLA) has been filed.\n\nSilviu Itescu, Chief Executive of Mesoblast, said: “This is a major\nmilestone toward delivering on our corporate goal of bringing to market a\nnon-opioid, disease-modifying therapy for patients suffering from chronic low\nback pain, a condition with significant unmet medical need.”\n\nCLBP caused by inflammation and degenerative disc disease is a serious\ncondition with a prevalence of over 7 million people in the U.S. alone. The\nindication is a potential blockbuster for Mesoblast with potential peak year\nrevenue of >US$10 billion with single digit market penetration.\n\nAbout Rexlemestrocel-L for Chronic Low Back Pain associated with Degenerative\nDisc Disease \nThe 300-patient randomized controlled confirmatory Phase 3 trial of\nMesoblast’s second generation allogeneic, STRO3-immunoselected, and\nindustrially manufactured stromal cell product candidate rexlemestrocel-L in\ncombination with hyaluronic acid (HA) as delivery agent for injection into the\nlumbar disc is actively enrolling in patients with chronic low back pain\n(CLBP) due to inflammatory degenerative disc disease (DDD) of less than five\nyears duration at multiple sites across the U.S.\n\nFDA has previously agreed on the design of this 300-patient randomized,\nplacebo-controlled confirmatory Phase 3 trial, and the 12-month primary\nendpoint of pain reduction as an approvable indication. This endpoint was\nsuccessfully met in Mesoblast’s first Phase 3 trial. Key secondary measures\ninclude improvement in quality of life and function.\n\nA particular focus is on treatment of patients on opioids, since discogenic\nback pain accounts for approximately 50% of prescription opioid usage in the\nUS. Significant pain reduction and opioid cessation were observed in\nMesoblast’s first Phase 3 trial.\n\nFDA has designated rexlemestrocel-L a Regenerative Medicine Advanced Therapy\n(RMAT) for the treatment of chronic low back pain. RMAT designation provides\nall the benefits of Breakthrough and Fast Track designations, including\nrolling review and eligibility for priority review on filing of a Biologics\nLicense Application (BLA).\n\nAbout Chronic Low Back Pain\nBack pain is the leading cause of disability in Americans under 45 years,(1)\nwith an annual prevalence in the general US adult population of 10-30%.(2)\nCLBP caused by inflammation and degenerative disc disease (DDD) is a serious\ncondition with a prevalence of over 7 million people in the US alone.(3,4)\nCLBP due to DDD is a leading cause of disability, and is associated with\nimpaired quality of life, severe limitations in ability to perform activities\nof daily living, reduced ability to work, and negative impacts on mental\nhealth. CLBP accounts for approximately 50% of prescription opioid usage in\nthe US,(5) making the condition a significant contributor to the opioid\nepidemic.\n\nAbout Mesoblast \nMesoblast (the Company) is a world leader in developing allogeneic\n(off-the-shelf) cellular medicines for the treatment of severe and\nlife-threatening inflammatory conditions. The therapies from the Company’s\nproprietary mesenchymal lineage cell therapy technology platform respond to\nsevere inflammation by releasing anti-inflammatory factors that counter and\nmodulate multiple effector arms of the immune system, resulting in significant\nreduction of the damaging inflammatory process.\n\nMesoblast’s Ryoncil(®) (remestemcel-L-rknd) for the treatment of\nsteroid-refractory acute graft versus host disease (SR-aGvHD) in pediatric\npatients 2 months and older is the first FDA-approved mesenchymal stromal cell\n(MSC) therapy. Please see the full Prescribing Information at www.ryoncil.com.\n\nMesoblast is committed to developing additional cell therapies for distinct\nindications based on its remestemcel-L and rexlemestrocel-L allogeneic stromal\ncell technology platforms. Ryoncil(®) is being developed for additional\ninflammatory diseases including SR-aGvHD in adults and biologic-resistant\ninflammatory bowel disease. Rexlemestrocel-L is being developed for heart\nfailure and chronic low back pain. The Company has established commercial\npartnerships in Japan, Europe and China.\n\nAbout Mesoblast intellectual property: Mesoblast has a strong and extensive\nglobal intellectual property portfolio, with over 1,000 granted patents or\npatent applications covering mesenchymal stromal cell compositions of matter,\nmethods of manufacturing and indications. These granted patents and patent\napplications provide commercial protection extending through to at least 2044\nin all major markets.\n\nAbout Mesoblast manufacturing: The Company’s proprietary manufacturing\nprocesses yield industrial-scale, cryopreserved, off-the-shelf, cellular\nmedicines. These cell therapies, with defined pharmaceutical release criteria,\nare planned to be readily available to patients worldwide.\n\nMesoblast has locations in Australia, the United States and Singapore and is\nlisted on the Australian Securities Exchange (MSB) and on the Nasdaq (MESO).\nFor more information, please see www.mesoblast.com, LinkedIn: Mesoblast\nLimited and Twitter: @Mesoblast\n\nReferences / Footnotes\n1. American Academy of Pain Medicine - Get the Facts on Pain. The American\nAcademy of Pain Medicine. http://www.painmed.org/patientcenter/facts-on-pain/\nAccessed on June 28, 2017.\n2. Urits I, Burshtein A, Sharma M, et al. Low Back Pain, a Comprehensive\nReview: Pathophysiology, Diagnosis, and Treatment. Current Pain and Headache\nReports. 2019;23(3):1-10. doi:10.1007/s11916-019-0757-1.\n3. Navigant: Commercial Assessment for a Proprietary Cell-Based Therapy for\nDDD in the U.S. and the EU3 – August 2014.\n4. Decision Resources: Chronic Pain December 2015.\nForward-Looking Statements\nThis press release includes forward-looking statements that relate to future\nevents or our future financial performance and involve known and unknown\nrisks, uncertainties and other factors that may cause our actual results,\nlevels of activity, performance or achievements to differ materially from any\nfuture results, levels of activity, performance or achievements expressed or\nimplied by these forward-looking statements. We make such forward-looking\nstatements pursuant to the safe harbor provisions of the Private Securities\nLitigation Reform Act of 1995 and other federal securities laws.\nForward-looking statements should not be read as a guarantee of future\nperformance or results, and actual results may differ from the results\nanticipated in these forward-looking statements, and the differences may be\nmaterial and adverse. Forward-looking statements include, but are not limited\nto, statements about: the initiation, timing, progress and results of\nMesoblast’s preclinical and clinical studies, and Mesoblast’s research and\ndevelopment programs; Mesoblast’s ability to advance product candidates\ninto, enroll and successfully complete, clinical studies, including\nmulti-national clinical trials; Mesoblast’s ability to advance its\nmanufacturing capabilities; the timing or likelihood of regulatory filings and\napprovals, manufacturing activities and product marketing activities, if any;\nthe commercialization of Mesoblast’s RYONCIL for pediatric SR-aGVHD and any\nother product candidates, if approved; regulatory or public perceptions and\nmarket acceptance surrounding the use of stem-cell based therapies; the\npotential for Mesoblast’s product candidates, if any are approved, to be\nwithdrawn from the market due to patient adverse events or deaths; the\npotential benefits of strategic collaboration agreements and Mesoblast’s\nability to enter into and maintain established strategic collaborations;\nMesoblast’s ability to establish and maintain intellectual property on its\nproduct candidates and Mesoblast’s ability to successfully defend these in\ncases of alleged infringement; the scope of protection Mesoblast is able to\nestablish and maintain for intellectual property rights covering its product\ncandidates and technology; estimates of Mesoblast’s expenses, future\nrevenues, capital requirements and its needs for additional financing;\nMesoblast’s financial performance; developments relating to Mesoblast’s\ncompetitors and industry; and the pricing and reimbursement of Mesoblast’s\nproduct candidates, if approved. You should read this press release together\nwith our risk factors, in our most recently filed reports with the SEC or on\nour website. Uncertainties and risks that may cause Mesoblast’s actual\nresults, performance or achievements to be materially different from those\nwhich may be expressed or implied by such statements, and accordingly, you\nshould not place undue reliance on these forward-looking statements. We do not\nundertake any obligations to publicly update or revise any forward-looking\nstatements, whether as a result of new information, future developments or\notherwise.\n\nRelease authorized by the Chief Executive.\n\nFor more information, please contact:\n\n Corporate Communications / Investors                           \n Paul Hughes                                                    \n T: +61 3 9639 6036                                             \n                                                                \n Media – Global                        Media – Australia        \n Rubenstein                            BlueDot Media            \n Caroline Nelson                       Steve Dabkowski          \n T: +1 703 489 3037                    T: +61 419 880 486       \n E: cnelson@rubenstein.com             E: steve@bluedot.net.au  \n\n\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/a9938a8a-a0ba-4708-abd5-2219515343fc)\n\n\n\nGlobeNewswire, Inc. 2026","article_body_html":"","raw_payload":{"data":{"id":"nGNX1Kzpj9","title":"Mesoblast Achieves Patient Recruitment Target in Pivotal Phase 3 Trial for Chronic Low Back Pain ","author":"Globe Newswire","ticker":"MSB","created":"2026-04-29T00:53:16.107Z","tickers":["MSB"],"exchange":"ASX","article_body":"NEW YORK, April 28, 2026 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO;\nASX:MSB), global leader in allogeneic cellular medicines for inflammatory\ndiseases, today announced that its pivotal Phase 3 clinical trial evaluating\nrexlemestrocel-L for the treatment of chronic low back pain (CLBP) associated\nwith degenerative disc disease has achieved its patient recruitment target.\nThis marks a significant milestone in Mesoblast’s plans for\ncommercialization of rexlemestrocel-L, its proprietary allogeneic stromal cell\ntherapy targeting inflammatory processes underlying disc degeneration.\n\nThe placebo-controlled study (MSB-DR004) will follow at least 300 patients\nrandomized to a single intra-discal injection of rexlemestrocel-L or sham\ncontrol for 12 months. The trial seeks to confirm results from the earlier\nMSB-DR003 trial where a single intra-discal injection of rexlemestrocel-L\nresulted in clinically meaningful reductions in pain and opioid usage for up\nto three years.\n\nThe trial’s primary endpoint is powered to show a significant difference in\nreduction of low back pain at 12 months between rexlemestrocel-L and sham\ncontrols. Secondary endpoints include improvements in function, quality of\nlife, and cessation of pain medication, including opioids.\n\nTop-line results are expected in mid-CY2027 after the last randomized patient\nhas completed follow-up. A positive readout will be used in support of an\nexpected regulatory filing in Q3 CY2027 for United States Food and Drug\nAdministration (FDA) approval. Rexlemestrocel-L has Regenerative Medicine\nAdvanced Therapy (RMAT) designation from the FDA for treatment of CLBP due to\ndegenerative disc disease providing eligibility for priority review once the\nBiologics License Application (BLA) has been filed.\n\nSilviu Itescu, Chief Executive of Mesoblast, said: “This is a major\nmilestone toward delivering on our corporate goal of bringing to market a\nnon-opioid, disease-modifying therapy for patients suffering from chronic low\nback pain, a condition with significant unmet medical need.”\n\nCLBP caused by inflammation and degenerative disc disease is a serious\ncondition with a prevalence of over 7 million people in the U.S. alone. The\nindication is a potential blockbuster for Mesoblast with potential peak year\nrevenue of >US$10 billion with single digit market penetration.\n\nAbout Rexlemestrocel-L for Chronic Low Back Pain associated with Degenerative\nDisc Disease \nThe 300-patient randomized controlled confirmatory Phase 3 trial of\nMesoblast’s second generation allogeneic, STRO3-immunoselected, and\nindustrially manufactured stromal cell product candidate rexlemestrocel-L in\ncombination with hyaluronic acid (HA) as delivery agent for injection into the\nlumbar disc is actively enrolling in patients with chronic low back pain\n(CLBP) due to inflammatory degenerative disc disease (DDD) of less than five\nyears duration at multiple sites across the U.S.\n\nFDA has previously agreed on the design of this 300-patient randomized,\nplacebo-controlled confirmatory Phase 3 trial, and the 12-month primary\nendpoint of pain reduction as an approvable indication. This endpoint was\nsuccessfully met in Mesoblast’s first Phase 3 trial. Key secondary measures\ninclude improvement in quality of life and function.\n\nA particular focus is on treatment of patients on opioids, since discogenic\nback pain accounts for approximately 50% of prescription opioid usage in the\nUS. Significant pain reduction and opioid cessation were observed in\nMesoblast’s first Phase 3 trial.\n\nFDA has designated rexlemestrocel-L a Regenerative Medicine Advanced Therapy\n(RMAT) for the treatment of chronic low back pain. RMAT designation provides\nall the benefits of Breakthrough and Fast Track designations, including\nrolling review and eligibility for priority review on filing of a Biologics\nLicense Application (BLA).\n\nAbout Chronic Low Back Pain\nBack pain is the leading cause of disability in Americans under 45 years,(1)\nwith an annual prevalence in the general US adult population of 10-30%.(2)\nCLBP caused by inflammation and degenerative disc disease (DDD) is a serious\ncondition with a prevalence of over 7 million people in the US alone.(3,4)\nCLBP due to DDD is a leading cause of disability, and is associated with\nimpaired quality of life, severe limitations in ability to perform activities\nof daily living, reduced ability to work, and negative impacts on mental\nhealth. CLBP accounts for approximately 50% of prescription opioid usage in\nthe US,(5) making the condition a significant contributor to the opioid\nepidemic.\n\nAbout Mesoblast \nMesoblast (the Company) is a world leader in developing allogeneic\n(off-the-shelf) cellular medicines for the treatment of severe and\nlife-threatening inflammatory conditions. The therapies from the Company’s\nproprietary mesenchymal lineage cell therapy technology platform respond to\nsevere inflammation by releasing anti-inflammatory factors that counter and\nmodulate multiple effector arms of the immune system, resulting in significant\nreduction of the damaging inflammatory process.\n\nMesoblast’s Ryoncil(®) (remestemcel-L-rknd) for the treatment of\nsteroid-refractory acute graft versus host disease (SR-aGvHD) in pediatric\npatients 2 months and older is the first FDA-approved mesenchymal stromal cell\n(MSC) therapy. Please see the full Prescribing Information at www.ryoncil.com.\n\nMesoblast is committed to developing additional cell therapies for distinct\nindications based on its remestemcel-L and rexlemestrocel-L allogeneic stromal\ncell technology platforms. Ryoncil(®) is being developed for additional\ninflammatory diseases including SR-aGvHD in adults and biologic-resistant\ninflammatory bowel disease. Rexlemestrocel-L is being developed for heart\nfailure and chronic low back pain. The Company has established commercial\npartnerships in Japan, Europe and China.\n\nAbout Mesoblast intellectual property: Mesoblast has a strong and extensive\nglobal intellectual property portfolio, with over 1,000 granted patents or\npatent applications covering mesenchymal stromal cell compositions of matter,\nmethods of manufacturing and indications. These granted patents and patent\napplications provide commercial protection extending through to at least 2044\nin all major markets.\n\nAbout Mesoblast manufacturing: The Company’s proprietary manufacturing\nprocesses yield industrial-scale, cryopreserved, off-the-shelf, cellular\nmedicines. These cell therapies, with defined pharmaceutical release criteria,\nare planned to be readily available to patients worldwide.\n\nMesoblast has locations in Australia, the United States and Singapore and is\nlisted on the Australian Securities Exchange (MSB) and on the Nasdaq (MESO).\nFor more information, please see www.mesoblast.com, LinkedIn: Mesoblast\nLimited and Twitter: @Mesoblast\n\nReferences / Footnotes\n1. American Academy of Pain Medicine - Get the Facts on Pain. The American\nAcademy of Pain Medicine. http://www.painmed.org/patientcenter/facts-on-pain/\nAccessed on June 28, 2017.\n2. Urits I, Burshtein A, Sharma M, et al. Low Back Pain, a Comprehensive\nReview: Pathophysiology, Diagnosis, and Treatment. Current Pain and Headache\nReports. 2019;23(3):1-10. doi:10.1007/s11916-019-0757-1.\n3. Navigant: Commercial Assessment for a Proprietary Cell-Based Therapy for\nDDD in the U.S. and the EU3 – August 2014.\n4. Decision Resources: Chronic Pain December 2015.\nForward-Looking Statements\nThis press release includes forward-looking statements that relate to future\nevents or our future financial performance and involve known and unknown\nrisks, uncertainties and other factors that may cause our actual results,\nlevels of activity, performance or achievements to differ materially from any\nfuture results, levels of activity, performance or achievements expressed or\nimplied by these forward-looking statements. We make such forward-looking\nstatements pursuant to the safe harbor provisions of the Private Securities\nLitigation Reform Act of 1995 and other federal securities laws.\nForward-looking statements should not be read as a guarantee of future\nperformance or results, and actual results may differ from the results\nanticipated in these forward-looking statements, and the differences may be\nmaterial and adverse. Forward-looking statements include, but are not limited\nto, statements about: the initiation, timing, progress and results of\nMesoblast’s preclinical and clinical studies, and Mesoblast’s research and\ndevelopment programs; Mesoblast’s ability to advance product candidates\ninto, enroll and successfully complete, clinical studies, including\nmulti-national clinical trials; Mesoblast’s ability to advance its\nmanufacturing capabilities; the timing or likelihood of regulatory filings and\napprovals, manufacturing activities and product marketing activities, if any;\nthe commercialization of Mesoblast’s RYONCIL for pediatric SR-aGVHD and any\nother product candidates, if approved; regulatory or public perceptions and\nmarket acceptance surrounding the use of stem-cell based therapies; the\npotential for Mesoblast’s product candidates, if any are approved, to be\nwithdrawn from the market due to patient adverse events or deaths; the\npotential benefits of strategic collaboration agreements and Mesoblast’s\nability to enter into and maintain established strategic collaborations;\nMesoblast’s ability to establish and maintain intellectual property on its\nproduct candidates and Mesoblast’s ability to successfully defend these in\ncases of alleged infringement; the scope of protection Mesoblast is able to\nestablish and maintain for intellectual property rights covering its product\ncandidates and technology; estimates of Mesoblast’s expenses, future\nrevenues, capital requirements and its needs for additional financing;\nMesoblast’s financial performance; developments relating to Mesoblast’s\ncompetitors and industry; and the pricing and reimbursement of Mesoblast’s\nproduct candidates, if approved. You should read this press release together\nwith our risk factors, in our most recently filed reports with the SEC or on\nour website. Uncertainties and risks that may cause Mesoblast’s actual\nresults, performance or achievements to be materially different from those\nwhich may be expressed or implied by such statements, and accordingly, you\nshould not place undue reliance on these forward-looking statements. We do not\nundertake any obligations to publicly update or revise any forward-looking\nstatements, whether as a result of new information, future developments or\notherwise.\n\nRelease authorized by the Chief Executive.\n\nFor more information, please contact:\n\n Corporate Communications / Investors                           \n Paul Hughes                                                    \n T: +61 3 9639 6036                                             \n                                                                \n Media – Global                        Media – Australia        \n Rubenstein                            BlueDot Media            \n Caroline Nelson                       Steve Dabkowski          \n T: +1 703 489 3037                    T: +61 419 880 486       \n E: cnelson@rubenstein.com             E: steve@bluedot.net.au  \n\n\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/a9938a8a-a0ba-4708-abd5-2219515343fc)\n\n\n\nGlobeNewswire, Inc. 2026"},"type":"article","timestamp":"2026-04-29T00:53:16.148109703Z","server_sent_at_ms":1777423996148},"received_at":"2026-04-29T00:53:16.478Z","source_url":"https://www.globenewswire.com/news-release/2019/01/07/1681053/0/en/phase-3-trial-of-mesoblast-s-cell-therapy-in-chronic-heart-failure-completes-recruitment.html"},"analysis":{"id":"9327","press_release_id":"12011","analysis_json":{"industry":{"label":"Pharmaceuticals, Biotechnology & Life Sciences","sector":"Health Care"},"redFlags":[],"eventType":"clinical_trial","narrative":"Mesoblast announced that it has achieved the patient recruitment target for its pivotal Phase 3 trial of rexlemestrocel-L in patients with chronic low back pain associated with degenerative disc disease.\n\nThe 300-patient placebo-controlled study will assess pain reduction over 12 months, with top-line data expected in mid-2027 to support a planned regulatory filing in the third quarter of 2027.\n\nManagement highlighted the significant commercial opportunity, noting the therapy targets a condition affecting over 7 million people in the U.S. with potential peak revenue exceeding $10 billion.","sentiment":"bullish","agentHooks":{"shouldPost":true,"suggestedAngle":"Recruitment milestone clears path for 2027 readout of potential blockbuster back pain therapy."},"keyFigures":{"drugName":"rexlemestrocel-L","phaseOfTrial":"Phase 3","customDimensions":{"patients":300,"us_prevalence":"over 7 million","top_line_results_date":"mid-CY2027","regulatory_filing_date":"Q3 CY2027"}},"quotedText":"This is a major milestone toward delivering on our corporate goal of bringing to market a non-opioid, disease-modifying therapy for patients suffering from chronic low back pain, a condition with significant unmet medical need.","namedEntities":{"people":[{"name":"Silviu Itescu","role":"Chief Executive"},{"name":"Paul Hughes","role":"Corporate Communications / Investors"}],"products":["rexlemestrocel-L","Ryoncil (remestemcel-L-rknd)"],"companies":[{"name":"Mesoblast Limited","ticker":"MSB"}],"dollarAmounts":[{"amount":">US$10 billion","context":"potential peak year revenue"}]},"materialImpact":{"score":4,"reasoning":"Completion of patient recruitment in a pivotal Phase 3 trial removes a key execution risk for the company's lead potential blockbuster asset and confirms the path to a 2027 regulatory filing."},"tickerRelevance":{"others":[{"ticker":"MESO","relevance":"primary"}],"primary":"MSB"},"globalImportance":30,"audienceRelevance":40,"eventTypeSecondary":[],"importanceComponents":{"tickerTier":"small/mid-cap","eventGravity":"pivotal trial recruitment milestone","regulatoryStatus":"RMAT designation held","commercialPotential":">$10B peak revenue cited"}},"event_type":"clinical_trial","event_type_secondary":null,"sentiment":"bullish","material_impact_score":4,"narrative":"Mesoblast announced that it has achieved the patient recruitment target for its pivotal Phase 3 trial of rexlemestrocel-L in patients with chronic low back pain associated with degenerative disc disease.\n\nThe 300-patient placebo-controlled study will assess pain reduction over 12 months, with top-line data expected in mid-2027 to support a planned regulatory filing in the third quarter of 2027.\n\nManagement highlighted the significant commercial opportunity, noting the therapy targets a condition affecting over 7 million people in the U.S. with potential peak revenue exceeding $10 billion.","key_figures":{"drugName":"rexlemestrocel-L","phaseOfTrial":"Phase 3","customDimensions":{"patients":300,"us_prevalence":"over 7 million","top_line_results_date":"mid-CY2027","regulatory_filing_date":"Q3 CY2027"}},"named_entities":{"people":[{"name":"Silviu Itescu","role":"Chief Executive"},{"name":"Paul Hughes","role":"Corporate Communications / Investors"}],"products":["rexlemestrocel-L","Ryoncil (remestemcel-L-rknd)"],"companies":[{"name":"Mesoblast Limited","ticker":"MSB"}],"dollarAmounts":[{"amount":">US$10 billion","context":"potential peak year revenue"}]},"model_name":"glm-4.7","prompt_hash":"sha256:1fc968c3ac7f7ebb","schema_hash":"sha256:1f8af1196c7db48c","created_at":"2026-04-29T00:58:04.400Z","global_importance":30,"audience_relevance":40,"importance_components":{"tickerTier":"small/mid-cap","eventGravity":"pivotal trial recruitment milestone","regulatoryStatus":"RMAT designation held","commercialPotential":">$10B peak revenue cited"}},"durationMs":41013,"modelName":"glm-4.7"}}