NEW YORK, Jan. 28, 2026 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided highlights of its recent activities for the second fiscal quarter ended December 31, 2025. “This quarter was highlighted by continued strong Ryoncil® sales and the establishment of a new lower-cost non-dilutive financing facility both of which enable greater flexibility for strategic partnerships and pursuit of label expansion for Ryon ...

NEW YORK, Jan. 26, 2026 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided an update on use of Ryoncil® (remestemcel-L-rknd) since commercially available in March 2025 for the approved label in children 2 months and older with steroid-refractory acute graft-versus-host disease (SR-aGvHD). Ryoncil® is the first mesenchymal stromal cell (MSC) product approved by the U.S. Food & Drug Administration (FDA) for any ...

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]

Market Overview - The US market is experiencing significant news with the Federal Reserve being served a subpoena by Donald Trump's Department of Justice, which is perceived as a threat of criminal indictment against Jerome Powell [2][3] - This situation is expected to influence market commentary and trading, particularly affecting gold prices and NASDAQ futures [3] Company Performances - Imricor Medical Systems saw a substantial increase of nearly +20% after receiving FDA approval for its heart catheter device designed for MRI machines [4] - Light & Wonder's stock rose following the resolution of a dispute with Aristocrat Leisure over IP theft, resulting in a payment of nearly $200 million [5] - GreenX Metals' shares increased to $1 as it anticipates a payment of nearly $400 million from the Polish government in a long-running dispute [5] Declining Stocks - 4D Medical's shares are declining after a rapid increase in previous weeks, trading around $4.30 [5] - Mesoblast's stock is down approximately -5% despite posting record US revenues last week [6] - Super Retail Group's shares fell over -5% following a trading update that did not meet investor expectations [6]

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]

Market Performance - Major stock markets in Asia closed on a mixed note due to shortened trading hours, holidays, and thin trading volume, with most markets on track for strong year-end gains driven by the AI boom [1] - China's Shanghai Composite Index increased by 0.09 percent to close at 3,968.84, with a trading range of 3,955.49 to 3,977.54 [2] - The Shenzhen Component Index decreased by 0.58 percent, closing at 13,525.02, down from 13,604.07 [2] - The Hang Seng Index fell by 0.87 percent, closing at 25,606.37, with a trading range between 25,791.50 and 25,522.00 [2] Australia and New Zealand Markets - Australia's S&P/ASX200 closed at 8,714.30, down 0.03 percent from the previous close, with a trading range of 8,679.80 to 8,732.20 [3] - Silex Systems saw a rebound of 3.9 percent, while IDP Education, Digico Infrastructure REIT, Paladin Energy, and Nickel Industries all gained over 2 percent [3] - The NZX 50 in New Zealand closed flat at 13,548.42, with a trading range of 13,522.12 to 13,590.70 [4] - KMD Brands surged by 3.6 percent, while Investore Property, Westpac Banking Corp, and Summerset Group Holdings all rallied more than 1 percent [4] Wall Street Performance - Wall Street closed negatively as concerns over AI valuations of major tech companies overshadowed expectations for further easing by the Federal Reserve [5] - The Dow Jones Industrial Average decreased by 0.20 percent, finishing at 48,367.06, while the Nasdaq Composite dropped by 0.24 percent to close at 23,419.08 [5]

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].

We recently published 7 Best ASX Stocks to Buy Right Now.  Mesoblast Limited (NASDAQ:MESO) is one of the best ASX stocks. Mesoblast Limited (NASDAQ:MESO) is a biotechnology company developing treatments for inflammatory diseases, heart failure, and other ailments. On November 25th, Jefferies upgraded the firm’s shares to Buy from Hold and increased the share price target to AUD3.30 from AUD3.00. The financial firm cited Mesoblast Limited (NASDAQ:MESO)’s Ryoncil drug as the reason behind its optimism. Jeff ...

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]