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]

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]

Core Viewpoint - The discussion around "celebrity rejuvenation" highlights the ongoing advancements in the global biomedical field, which are bringing humanity closer to extending lifespan through various innovative therapies and technologies [1][2]. Group 1: Advances in Biomedical Technology - Continuous breakthroughs in life sciences are making the ancient human desire for longevity increasingly attainable, pending large-scale commercialization and official endorsement [1]. - Technologies such as stem cells, mitochondrial transplants, and induced pluripotent stem cells (iPSC) are at the forefront of research aimed at extending human life [1][14]. - The approval of the first mesenchymal stem cell product for treating children with steroid-refractory acute graft-versus-host disease (SR-aGVHD) in the U.S. marks a significant milestone in stem cell therapy [23]. Group 2: Market Dynamics and Commercialization - The commercial pathways for longevity-related drugs and therapies are becoming clearer, with a growing demand driving initial implementations in aging delay and specific disease treatments [2]. - The pricing of stem cell therapies in China is significantly lower than similar products in the U.S., making them more accessible [25]. Group 3: Ethical and Social Considerations - There are substantial ethical concerns regarding the commercialization of longevity treatments, particularly the potential for creating a divide where only the wealthy can afford life-extending therapies [22][30]. - The pursuit of longevity by the elite raises questions about the implications for societal dynamics and the potential emergence of a "blood-hunting" class [22][30]. Group 4: Historical Context and Future Outlook - Historical attempts at achieving immortality, from ancient practices to modern biomedical research, reflect a long-standing human fascination with life extension [30]. - The future of longevity research may focus more on treating prevalent diseases rather than solely extending life for a select few, emphasizing the importance of quality of life over mere lifespan [29][30].

Summary of Mesoblast Conference Call Company Overview - **Company**: Mesoblast (NasdaqGS:MESO) - **Industry**: Allogeneic cellular medicines for inflammatory diseases - **Recent Milestone**: FDA approval received in December 2024, leading to significant developments in the company’s operations and product offerings [4][18] Key Points Discussed Leadership Changes - **New CFO Appointment**: Jim O'Brien appointed as CFO, bringing 25 years of experience in the pharmaceutical and biotech industries [6][14] Product Development and Trials - **Chronic Back Pain Product**: - Ongoing phase three trial enrolling 300 patients, expected to complete enrollment by March 2026 [18][21] - RMAT designation received, indicating a focus on non-opioid solutions for chronic pain, aligning with FDA's guidance on addressing the opioid crisis [18][19] - Data from a previous trial showed that 40% of patients on opioids at baseline had significant reductions in opioid use after treatment [20] - **Ryoncil Commercialization**: - Revenue for the September quarter reached approximately $22 million, with strong adoption from major transplant centers [33][35] - J code established for reimbursement, providing hospitals with pricing certainty and facilitating product adoption [38][40] Future Plans and Market Opportunities - **Label Expansion**: - Plans to initiate trials for adult use of Ryoncil in bone marrow transplant patients and inflammatory bowel diseases [41][50] - Collaboration with NIH for adult trials, with expectations for significant impact on patient outcomes [41][42] - **Heart Failure Product**: - Targeting a market of approximately 1 million patients in the U.S. with ischemia and inflammation [53] - Plans for accelerated approval in patients with LVAD, with a confirmatory study to follow in a larger patient population [53][54] Strategic Focus Areas - **2026 Priorities**: - Revenue growth and expansion into adult markets - Initiation of inflammatory bowel disease studies - Completion of the adult back pain trial and FDA filing for accelerated approval [58][59] Additional Insights - **Regulatory Environment**: The FDA's recent guidance encourages the development of non-opioid drugs, which aligns with Mesoblast's product strategy [54][55] - **Market Dynamics**: The opioid crisis remains a significant concern, with a high number of deaths attributed to opioid overdoses, emphasizing the need for alternative treatments [54] This summary encapsulates the critical developments and strategic directions discussed during the conference call, highlighting Mesoblast's commitment to addressing significant medical needs through innovative therapies.

Core Insights - Mesoblast Limited has appointed James M. O'Brien as the new Chief Financial Officer (CFO) to support its transition to a fully integrated commercial organization [1][2] - The company aims to enhance its financial leadership as it commercializes its product Ryoncil and seeks label expansion [2] Company Overview - Mesoblast is a global leader in developing allogeneic cellular medicines for severe inflammatory diseases, utilizing proprietary mesenchymal lineage cell therapy technology [3] - The company has a strong intellectual property portfolio with over 1,000 patents or applications, providing commercial protection until at least 2044 in major markets [6] Product Development - Ryoncil (remestemcel-L-rknd) is the first FDA-approved mesenchymal stromal cell therapy for treating steroid-refractory acute graft versus host disease (SR-aGvHD) in pediatric patients aged 2 months and older [4] - Mesoblast is developing additional therapies for various inflammatory diseases, including SR-aGvHD in adults and biologic-resistant inflammatory bowel disease, as well as heart failure and chronic low back pain [5] Financial Leadership - James M. O'Brien brings extensive experience in financial management from previous roles at Actavis plc, Cognition Therapeutics, and Faron Pharmaceuticals, among others [2] - His expertise includes overseeing corporate finance, reporting, internal controls, and accounting operations, with a history of managing transactions totaling nearly $10 billion [2]

Core Insights - Mesoblast Limited reported significant revenue growth driven by increased adoption of its product Ryoncil, with a permanent J-Code enhancing billing and reimbursement processes [2][4]. Financial Highlights - Revenue from cell therapy products reached US$20.6 million for the quarter ended September 30, 2025, up from US$12.9 million in the previous quarter, and over ten times greater than the same quarter last year [4]. - Ryoncil gross sales increased by 66% to US$21.9 million, while net sales rose by 69% to US$19.1 million after a 12.7% gross to net adjustment [4]. - The company reported a net operating cash spend of US$14.9 million, a reduction of US$1.7 million compared to the previous quarter, and had US$145 million cash on hand as of September 30, 2025 [4]. Operational Highlights - Mesoblast has onboarded 40 transplant centers since the product launch and identified 45 priority transplant centers that account for approximately 80% of U.S. pediatric transplants [4]. - Over 260 million U.S. lives are insured by commercial and government payers for Ryoncil, with federal Medicaid coverage in place [4]. - The company established a patient access hub, MyMesoblast™, to assist patients with insurance coverage and access to Ryoncil [4]. Regulatory and Development Updates - A specific J-Code (J3402) was assigned to Ryoncil by CMS, effective October 1, 2025, facilitating easier billing and reimbursement [4]. - Mesoblast plans to conduct a pivotal trial for Ryoncil in adults with severe steroid-refractory acute graft-versus-host disease (SR-aGvHD), aiming to extend its label from children to adults [5].

Group 1 - Fintech company Findi is facing legal issues after a user claimed misconduct on forums, prompting the company's legal team to get involved [2] - PainChek's app for aged care homes received FDA approval, leading to increased attention as the company now focuses on sales [3] - Mesoblast's stock is gaining traction again as its stem cell drug Ryoncil shows sales momentum in the USA [4] Group 2 - Race Oncology's stock reached an all-time high after revealing the mechanism of action for its drug Bisantrene, which is believed to be a chemotherapy drug without side effects [4] - Trigg Minerals is exploring options for a NASDAQ listing, including a potential SPAC listing, as it targets the US critical metals market [5] - Fintech Stakk remains popular after securing deals with Robinhood and T-Mobile, alongside a $15 million placement currently under review [6]

Group 1 - U.S. stock futures are higher, with Dow futures gaining approximately 100 points [1] - Quantum Computing Inc. raised $750 million from institutional investors in a market-priced private placement, leading to a sharp decline in its shares by 11.7% to $21.70 in pre-market trading [1] Group 2 - Rich Sparkle Holdings Ltd experienced a significant drop of 15% to $22.10 in pre-market trading after a 10% decline on Friday [3] - Nordic American Tankers Ltd fell 7.8% to $3.07 in pre-market trading [3] - Smurfit WestRock PLC shares decreased by 5.8% to $39.54 in pre-market trading [3] - Mesoblast Ltd shares declined 5.2% to $17.45 in pre-market trading, despite an 8% gain on Friday following the announcement of Ryoncil receiving a J-Code from Medicare & Medicaid Services [3] - Invesco Mortgage Capital Inc saw a decline of 4.4% to $7.42 in pre-market trading [3] - Inventiva ADR shares fell 4.2% to $6.26 in pre-market trading after the appointment of Andrew Obenshain as CEO [3] - International Paper Co dropped 4.2% to $45.21 in pre-market trading ahead of its third-quarter earnings release on October 30 [3] - Lufax Holding Ltd – ADR fell 3.7% to $3.85 in pre-market trading after an 8% decline on Friday [3] - Larimar Therapeutics Inc shares decreased by 3.3% to $4.71 in pre-market trading after a 14% jump on Friday [3]

Market Overview - U.S. stock futures are higher, with Dow futures gaining approximately 100 points [1] Quantum Computing Inc. - Quantum Computing Inc. (NASDAQ:QUBT) raised $750 million from institutional investors through a market-priced private placement led by top shareholders [1] - Shares of Quantum Computing fell sharply by 11.7% to $21.70 in pre-market trading [1] Other Stocks in Pre-Market Trading - Rich Sparkle Holdings Ltd (NASDAQ:ANPA) dropped 15% to $22.10 after a 10% decline on Friday [3] - Nordic American Tankers Ltd (NYSE:NAT) decreased by 7.8% to $3.07 [3] - Smurfit WestRock PLC (NYSE:SW) fell 5.8% to $39.54 [3] - Mesoblast Ltd (NASDAQ:MESO) declined 5.2% to $17.45, despite an 8% gain on Friday following the announcement of Ryoncil receiving a J-Code from Medicare & Medicaid Services [3] - Invesco Mortgage Capital Inc (NYSE:IVR) decreased by 4.4% to $7.42 [3] - Inventiva ADR (NASDAQ:IVA) fell 4.2% to $6.26 after appointing Andrew Obenshain as CEO [3] - International Paper Co (NYSE:IP) dropped 4.2% to $45.21 ahead of its third-quarter earnings release on October 30 [3] - Lufax Holding Ltd – ADR (NYSE:LU) fell 3.7% to $3.85 after an 8% decline on Friday [3] - Larimar Therapeutics Inc (NASDAQ:LRMR) decreased by 3.3% to $4.71 after a 14% jump on Friday [3]