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]

Major stock in Asia closed on a mixed note on Wednesday amidst shortened trading hours, holidays and thin trading volume. Most Asian markets were on track to end the year with strong gains fueled by AI boom. Equity markets in Japan and South Korea are closed for a holiday.China's Shanghai Composite Index edged up 0.09 percent to close at 3,968.84. The day's trading ranged between 3,955.49 and 3,977.54. The Shenzhen Component Index closed at 13,525.02, shedding 0.58 percent from the previous close of 13,604 ...

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]

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]

Summary of Mesoblast Conference Call Company Overview - **Company**: Mesoblast - **Products**: Ryoncil, Revascor - **Industry**: Biotechnology Key Points Ryoncil Launch and Performance - Ryoncil is successfully launched for treating steroid-refractory pediatric acute graft-versus-host disease (aGVHD) with net sales of **$30 million** in the first two quarters, with expectations to exceed this amount in the current quarter [4][34] - The pediatric market for aGVHD is estimated to have around **300-375 new cases** annually, with Mesoblast aiming to capture **30%** of the market within a year [7][10] - The company has established coverage with **260 million lives** under commercial insurance and has received Medicaid CMS coverage, which has facilitated the launch [6] Clinical Efficacy and Market Education - Ryoncil has shown a reduction in early mortality from **70%-90%** to about **20%** in treated patients, indicating a potential curative outcome [10] - The company is focusing on educating physicians to use Ryoncil as the first-line treatment for children with steroid-refractory disease [11] Expansion into Adult Market - Plans to conduct a phase III trial for adults with severe aGVHD, where the market is **three times larger** than the pediatric segment [15] - The FDA has suggested a randomized controlled trial for second-line treatment, combining Ryoncil with Ruxolitinib for severe cases [16][17] - Anticipated enrollment across **80 sites** in the U.S. with a potential filing for label expansion in **2027** [19] International and Other Indications - Mesoblast plans to file for regulatory approval in Europe using existing FDA documentation [20] - The company is exploring other indications such as inflammatory bowel disease and rare inflammatory diseases in children, leveraging its safety data [21] Revascor Development - Revascor, a second-generation product, targets cardiovascular diseases and has shown significant efficacy in reducing complications in ischemic heart disease patients by **60%-80%** [28] - The company is preparing for a BLA filing for Revascor in the first quarter, contingent on manufacturing readiness [30] Financial Position and Growth Strategy - Mesoblast reported approximately **$146 million** in cash at the end of the last quarter, with expectations of generating over **$30 million** in revenues this quarter [34] - The company is considering partnerships to accelerate development and unlock value across various indications, including neurodegenerative diseases [35] Manufacturing and Safety - Ryoncil is manufactured from U.S.-based human donors, with a focus on maintaining U.S. manufacturing as the company grows [23] Conclusion - Mesoblast is positioned for significant growth with its innovative therapies addressing unmet medical needs in both pediatric and adult populations, alongside a strong financial strategy and potential for international expansion [36]