Core Insights - Mesoblast Limited presented data on Ryoncil (remestemcel-L-rknd) at the February 2026 Tandem Meetings, highlighting its effectiveness in treating steroid-refractory acute graft-versus-host disease (SR-aGvHD) in both children and adults [1][2]. Group 1: Treatment Efficacy - Ryoncil demonstrated high survival outcomes in SR-aGvHD patients, regardless of age or treatment line, and is the first FDA-approved mesenchymal stromal cell product for this indication [2][6]. - In a study of 53 patients receiving Ryoncil as a third-line treatment, 15% died before completing the treatment, compared to only 2% in the Phase 3 trial for second-line treatment, indicating the importance of early intervention [3]. - Adult patients in the Emergency Investigational New Drug program showed survival rates comparable to children, supporting the rationale for a pivotal trial of Ryoncil in adults [4]. Group 2: Future Developments - A pivotal trial for Ryoncil's use in adults with severe SR-aGvHD is expected to begin enrollment this quarter, pending protocol approval [4]. - If successful, this trial could lead to an extension of Ryoncil's label for adult use, which represents a market approximately three times larger than that of pediatric patients [4]. Group 3: Company Overview - Mesoblast is a leader in developing allogeneic cellular medicines for severe inflammatory conditions, utilizing proprietary mesenchymal lineage cell therapy technology [5][7]. - The company has a robust intellectual property portfolio with over 1,000 patents or applications, providing commercial protection until at least 2044 [8]. - Mesoblast is also developing additional therapies for other inflammatory diseases and has established commercial partnerships in Japan, Europe, and China [7].

Core Viewpoint - Mesoblast Limited has provided an update on Ryoncil (remestemcel-L-rknd), the first FDA-approved mesenchymal stromal cell product for treating steroid-refractory acute graft-versus-host disease (SR-aGvHD) in children aged 2 months and older, highlighting its early survival rates and ongoing commercial efforts to expand its use [1][8]. Group 1: Clinical Outcomes - Among the first 25 patients treated with Ryoncil, 21 patients (84%) survived and completed the initial 28-day treatment regimen as per FDA approval [2] - The four patients who did not complete the treatment had previously failed other therapies and died from severe SR-aGvHD within 28 days, underscoring the importance of early intervention [2] Group 2: Patient Access and Coverage - Mesoblast has established a patient access hub, MyMesoblast™, to facilitate ordering Ryoncil, ensuring that patients can access this therapy [3] - Ryoncil is covered by government and commercial payers, reaching over 260 million U.S. lives, with specific billing codes issued by CMS enhancing its usage under federal coverage [4] Group 3: Market Expansion and Future Trials - The company aims to expand Ryoncil's FDA label to include adults with severe SR-aGvHD, targeting a market size approximately three times larger than the pediatric population [5] - A pivotal trial for Ryoncil in adults is set to commence site enrollment this quarter, in collaboration with the NIH-funded Bone Marrow Transplant Clinical Trials Network [5] Group 4: Company Overview and Technology - Mesoblast is a leader in developing allogeneic cellular medicines for severe inflammatory conditions, utilizing proprietary mesenchymal lineage cell therapy technology [7] - The company is also developing additional therapies for other inflammatory diseases and has established commercial partnerships in Japan, Europe, and China [9]

Core Insights - Mesoblast Limited is seeking FDA approval for its allogeneic cell therapy product rexlemestrocel-L aimed at treating chronic discogenic low back pain (CLBP) and potentially reducing opioid use [1][2][3] Group 1: FDA Feedback and Clinical Trials - The FDA has provided feedback indicating that a clinically meaningful reduction in pain intensity at 12 months can support the efficacy of rexlemestrocel-L [2] - The first Phase 3 trial (MSB-DR003) demonstrated significant pain reduction and opioid cessation, with over three times more patients able to stop using opioids compared to controls [7] - A second Phase 3 trial (MSB-DR004) is currently recruiting and is expected to complete enrollment of 300 patients within three months [3][5] Group 2: Opioid Crisis and Treatment Implications - CLBP is a major contributor to the U.S. opioid crisis, accounting for approximately 50% of prescription opioid usage [6][10] - The FDA has designated rexlemestrocel-L as a Regenerative Medicine Advanced Therapy (RMAT), which allows for expedited review processes [8] - Mesoblast's CEO highlighted the potential of rexlemestrocel-L to help manage chronic inflammatory back pain while contributing to opioid reduction goals [4] Group 3: Market Context and Company Overview - Chronic low back pain affects over 7 million people in the U.S. and is a leading cause of disability [9] - Mesoblast is a leader in developing allogeneic cellular medicines for severe inflammatory conditions, with a strong intellectual property portfolio [11][14] - The company is also developing additional therapies for other inflammatory diseases and has established commercial partnerships in various regions [13]

Core Viewpoint - U.S. stock futures are lower, with significant declines in several companies' shares during pre-market trading, particularly Exelixis Inc, which reported preliminary financial results for fiscal year 2025 [1]. Group 1: Exelixis Inc - Exelixis reported preliminary US net product revenue of $2.123 billion for fiscal year 2025 [1]. - The company projects net product revenue for 2026 to be between $2.325 billion and $2.425 billion [1]. - Exelixis shares fell 4.6% to $42.01 in pre-market trading following the announcement [1]. Group 2: Other Companies - Synchrony Financial shares dipped 9.5% to $78.61 in pre-market trading [3]. - Stoke Therapeutics Inc declined 8.7% to $30.00, announcing updates on enrollment timelines and Phase 3 data for zorevunersen [3]. - Capital One Financial Corp fell 8.4% to $228.35 in pre-market trading [3]. - Bread Financial Holdings Inc tumbled 8.3% to $73.72 [3]. - Himalaya Shipping Ltd dipped 5.7% to $8.72 [3]. - Mesoblast Ltd fell 5.1% to $19.90, despite a previous gain after reporting increased sales [3]. - American Express Co declined 5% to $357.00 [3]. - Lumentum Holdings Inc fell 4.7% to $335.00 [3]. - WPP PLC declined 4.5% to $22.63 [3]. - Citigroup Inc fell 4% to $116.50, with earnings results expected on January 14 [3].

Major stock in Asia closed on a positive note on Monday as a rally in Chinese AI stocks boosted sentiment. The global geopolitical situation as well as the escalation in tensions between the White House and the Federal Reserve limited gains. Equity markets in Japan are closed for a holiday.China's Shanghai Composite Index rallied 1.1 percent from the previous close of 4,120.43 to finish trading at 4,165.29. The day's trading ranged between 4,119.88 and 4,168.36. The Shenzhen Component Index closed at 14,36 ...

Core Viewpoint - Mesoblast Limited reported a significant revenue growth of 60% in Q4 2025, driven by Ryoncil sales, and secured a new $125 million financing facility to enhance its financial flexibility and support strategic initiatives [1][3][5]. Financial Performance - The company achieved gross revenue of $35.1 million from Ryoncil sales for the quarter ended December 31, 2025, marking a 60% increase compared to the previous quarter [1]. - The new financing facility of $125 million is a five-year interest-only arrangement that lowers the overall cost of capital and allows for repayment flexibility without penalties [4]. Product Development - Ryoncil is the first FDA-approved mesenchymal stromal cell product for children under 12 with steroid-refractory acute graft-versus-host disease (SR-aGvHD) and is set to enter a pivotal trial for adults with SR-aGvHD, a market three times larger than the pediatric segment [2][8]. - The company is also developing additional therapies for other inflammatory diseases and conditions, including biologic-resistant inflammatory bowel disease and heart failure [8]. Strategic Partnerships - The strong balance sheet and revenue growth provide Mesoblast with greater flexibility to pursue strategic partnerships and expand the label for Ryoncil [5]. - The company has established commercial partnerships in key markets including Japan, Europe, and China [8]. Intellectual Property - Mesoblast holds a robust global intellectual property portfolio with over 1,000 granted patents or applications, providing commercial protection until at least 2044 in major markets [9].

Core Insights - Mesoblast Limited is transitioning to a revenue-generating commercial company, as announced during the recent Annual General Meeting [1] Board Changes - Ms. Jane Bell will retire as Chair but remain on the Board as a non-executive director; Mr. Philip Facchina has been appointed as the new non-executive Chair, and Ms. Lyn Cobley will chair the Audit and Risk Committee [2] - Mr. Facchina brings over 40 years of experience in corporate strategy, finance, and business development, while Ms. Cobley has extensive corporate finance and governance experience [3] Governance and Strategy - The changes in the Board reflect a commitment to maintaining a high-performing Board with the right mix of expertise and fresh perspectives, aiming to maximize commercial delivery and shareholder value [4] - Mesoblast plans to strengthen its U.S. commercial expertise over the next twelve months [4] Company Overview - Mesoblast is a leader in developing allogeneic cellular medicines for severe inflammatory conditions, utilizing a proprietary mesenchymal lineage cell therapy technology platform [5] - The company’s Ryoncil (remestemcel-L-rknd) is the first FDA-approved mesenchymal stromal cell therapy for treating steroid-refractory acute graft versus host disease in pediatric patients [6] Product Development - Mesoblast is developing additional cell therapies for various indications, including SR-aGvHD in adults and biologic-resistant inflammatory bowel disease, as well as rexlemestrocel-L for heart failure and chronic low back pain [7] - The company has established commercial partnerships in Japan, Europe, and China [7] Intellectual Property - Mesoblast holds a strong global intellectual property portfolio with over 1,000 granted patents or applications, providing commercial protection until at least 2044 in major markets [8] Manufacturing Capabilities - The company’s proprietary manufacturing processes yield industrial-scale, cryopreserved, off-the-shelf cellular medicines, which are planned to be readily available to patients worldwide [9] Company Locations - Mesoblast operates in Australia, the United States, and Singapore, and is listed on both the Australian Securities Exchange and Nasdaq [10]

Core Viewpoint - Mesoblast Limited has secured a new credit facility of up to US$125 million, significantly improving its financial flexibility and reducing its cost of capital while allowing for strategic partnerships and commercialization opportunities [1][4]. Financial Summary - The new credit facility includes an initial drawdown of US$75 million, which is unsecured until the repayment of the NovaQuest debt by July 8, 2026, after which the total facility will be secured by the Temcell royalty [2][3]. - The facility has a fixed interest rate of 8.00% per annum, with a five-year interest-only period, representing a substantial reduction in overall cost compared to existing debt facilities [2][3]. Strategic Implications - The new facility does not encumber any of Mesoblast's material assets or intellectual property, providing total flexibility for the company in terms of additional unsecured debt or licensing activities [3]. - Dr. Gregory George, the provider of the facility, will receive warrants to purchase approximately 323,000 American Depositary Shares (ADSs) at a price of US$21.51 per ADS, which is a 15% premium to the current 30-day volume-weighted average price (VWAP) [3]. Company Overview - Mesoblast is a global leader in developing allogeneic cellular medicines for severe inflammatory diseases, utilizing proprietary mesenchymal lineage cell therapy technology [4][6]. - The company has established commercial partnerships in Japan, Europe, and China, and is committed to developing additional cell therapies for various indications [6]. Intellectual Property - Mesoblast holds a strong global intellectual property portfolio with over 1,000 granted patents or applications, providing commercial protection extending to at least 2044 in major markets [7]. Manufacturing Capabilities - The company employs proprietary manufacturing processes to produce industrial-scale, cryopreserved, off-the-shelf cellular medicines, ensuring availability to patients worldwide [8]. Market Position - Mesoblast is listed on both the Australian Securities Exchange (ASX: MSB) and Nasdaq (NASDAQ: MESO), indicating its significant presence in the global market [9].

Core Insights - Mesoblast Limited announced that remestemcel-L demonstrated superior efficacy and safety compared to ruxolitinib for treating steroid-refractory acute graft versus host disease (SR-aGvHD) at the 67th ASH Annual meeting [1][2] Company Overview - Mesoblast is a global leader in developing allogeneic cellular medicines for severe inflammatory diseases, utilizing a proprietary mesenchymal lineage cell therapy technology platform [4] - The company has a strong intellectual property portfolio with over 1,000 granted patents or applications, providing commercial protection until at least 2044 in major markets [7] - Mesoblast's manufacturing processes yield industrial-scale, cryopreserved, off-the-shelf cellular medicines, ensuring availability to patients worldwide [8] Product Information - Ryoncil (remestemcel-L) is the first FDA-approved mesenchymal stromal cell therapy for pediatric patients aged 2 months and older with SR-aGvHD [5] - The therapy is being developed for additional indications, including SR-aGvHD in adults and biologic-resistant inflammatory bowel disease, as well as heart failure and chronic low back pain [6] Clinical Study Findings - The meta-analysis included 2,732 patients across 11 studies, with remestemcel-L showing superior outcomes in complete and overall remission compared to ruxolitinib [2] - Both therapies improved quality of life, but remestemcel-L had better results in terms of hematology, cardiac, and hepatic adverse events [2]

Market Overview - The Australian share market experienced modest declines across major indices, with the S&P/ASX 20 closing at 4717.70, down 0.3% from an opening of 4732.70 [1] - The S&P/ASX 50 also fell by 0.3%, closing at 8222.20 after starting at 8250.60 [1] - Broader market indices, including the S&P/ASX 100 and S&P/ASX 300, both eased by 0.4%, ending at 7141.80 and 8540.80 respectively [2] Top Gainers - Austal Limited (ASB) was the top performer, rising to $6.650, an increase of $0.240 (3.744%) [5] - Mesoblast Limited (MSB) closed at $2.820, gaining $0.090 (3.296%) [5] - Deep Yellow Limited (DYL) increased by $0.055 (3.254%) to finish at $1.745 [5] - DroneShield Limited (DRO) advanced to $1.945, up $0.055 (2.910%) [5] - Medibank Private Limited (MPL) rounded out the top five, rising $0.120 (2.649%) to close at $4.650 [5] Top Losers - Bapcor Limited (BAP) suffered the largest decline, dropping to $1.850 after a decrease of $0.500 (-21.277%) [6] - NRW Holdings Limited (NWH) fell by $0.380 (-7.037%) to $5.020 [6] - Lynas Rare Earths Limited (LYC) declined to $12.930, down $0.680 (-4.997%) [6] - Super Retail Group Limited (SUL) slipped $0.740 (-4.551%) to end at $15.520 [6] - Life360 Inc. (360) closed at $36.360 after a drop of $1.470 (-3.886%) [6]