Core Insights - Mesoblast Limited announced a meeting with the FDA in early December to discuss data on opioid reduction and cessation from its Phase 3 study of rexlemestrocel-L for chronic low back pain [1][4] Company Overview - Mesoblast is a global leader in developing allogeneic cellular medicines for inflammatory diseases, focusing on severe and life-threatening conditions [10][11] - The company has a strong intellectual property portfolio with over 1,000 patents or applications, providing commercial protection until at least 2044 [14] Clinical Trial Details - The first Phase 3 trial involved 404 patients, with 168 on opioids at baseline; those treated with rexlemestrocel-L showed over 3-fold higher rates of opioid cessation compared to controls by 36 months (p=0.008) [2][6] - A confirmatory Phase 3 trial is actively enrolling 300 patients across 40 sites in the U.S., focusing on chronic low back pain due to degenerative disc disease [5][6] Regulatory Context - The FDA has emphasized the need for non-opioid treatments for chronic pain, with new guidance issued in September 2025 [3][4] - Rexlemestrocel-L has received Regenerative Medicine Advanced Therapy (RMAT) designation, allowing for benefits such as rolling review and priority review for its Biologics License Application [8] Market Need - Chronic low back pain affects over 7 million people in the U.S. and is a leading cause of disability, contributing to approximately 50% of prescription opioid usage [9][7]

Core Viewpoint - Mesoblast Limited (MESO) has been upgraded to a Zacks Rank 2 (Buy), indicating a positive outlook based on rising earnings estimates, which significantly influence stock prices [1][3]. Earnings Estimates and Stock Impact - The Zacks rating system emphasizes the importance of changing earnings estimates as a key driver of stock price movements, with institutional investors using these estimates to assess fair value [4][6]. - For Mesoblast Limited, the increase in earnings estimates suggests an improvement in the company's underlying business, likely leading to a higher stock price [5][10]. Earnings Estimate Revisions - Mesoblast Limited is projected to earn -$0.30 per share for the fiscal year ending June 2026, showing no year-over-year change [8]. - Over the past three months, the Zacks Consensus Estimate for Mesoblast has increased by 18.1%, reflecting a positive trend in earnings estimates [8]. Zacks Rank System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with only the top 20% receiving a "Strong Buy" or "Buy" rating, indicating superior earnings estimate revisions [9][10]. - The upgrade of Mesoblast Limited to Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, suggesting potential for market-beating returns in the near term [10].

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].

Market Overview - U.S. stock futures are lower, with Dow futures dropping over 200 points on Friday [1] Company-Specific Movements - Bitfarms Ltd (NASDAQ:BITF) shares fell 9.5% to $4.78 in pre-market trading after announcing the pricing of upsized $500 million convertible senior notes [1] - American Battery Technology Co (NASDAQ:ABAT) shares tumbled 19.8% to $4.55 in pre-market trading, following a 37% decline on Thursday due to the termination of a Department of Energy grant [3] - HIVE Digital Technologies Ltd (NASDAQ:HIVE) shares dipped 18.2% to $4.78 in pre-market trading after a 14% decline on Thursday [3] - Standard Lithium Ltd (NYSE:SLI) shares declined 17.3% to $4.45 in pre-market trading after pricing a $130 million underwritten public offering [3] - Almonty Industries Inc (NASDAQ:ALM) slipped 16.4% to $7.11 in pre-market trading after a 12% dip on Thursday [3] - Mesoblast Ltd (NASDAQ:MESO) declined 13.7% to $15.63 in pre-market trading [3] - Jumia Technologies AG – ADR (NYSE:JMIA) shares fell 13.2% to $10.31 in pre-market trading [3] - Terawulf Inc (NASDAQ:WULF) shares fell 13.1% to $12.05 after reporting the pricing of $3.2 billion of senior secured notes [3] - Diginex Ltd (NASDAQ:DGNX) shares slipped 13.1% to $14.45 after an 18% decline on Thursday [3] - Aeluma Inc (NASDAQ:ALMU) shares fell 12.1% to $16.46 in pre-market trading [3] - Compass Diversified Holdings (NYSE:CODI) declined 11.7% to $6.60 in pre-market trading after an 8% gain on Thursday [3] - Integra Resources Corp (NYSE:ITRG) fell 11.3% to $2.89 in pre-market trading [3] - Forward Industries Inc (NASDAQ:FORD) fell 10.8% to $22.00 in pre-market trading [3] - Bruker Corp (NASDAQ:BRKR) declined 10.3% to $34.25 in pre-market trading [3] - Inter & Co Inc (NASDAQ:INTR) fell 10% to $8.04 in pre-market trading [3] - Hut 8 Corp (NASDAQ:HUT) fell 8.5% to $44.59 in pre-market trading after a 10% dip on Thursday [3] - Bitdeer Technologies Group (NASDAQ:BTDR) fell 8.2% to $23.75 in pre-market trading [3] - CleanSpark Inc (NASDAQ:CLSK) fell 7.5% to $18.49 in pre-market trading [3] - Kratos Defense & Security Solutions Inc (NASDAQ:KTOS) fell 5.3% to $83.96 in pre-market trading [3]

Market Overview - U.S. stock futures are lower, with Dow futures dropping over 200 points on Friday [1] Company-Specific Movements - Bitfarms Ltd (NASDAQ:BITF) shares fell 9.5% to $4.78 in pre-market trading after announcing the pricing of upsized $500 million convertible senior notes [1] - American Battery Technology Co (NASDAQ:ABAT) shares tumbled 19.8% to $4.55 in pre-market trading, following a 37% decline on Thursday due to the termination of a Department of Energy grant [3] - HIVE Digital Technologies Ltd (NASDAQ:HIVE) shares dipped 18.2% to $4.78 in pre-market trading after a 14% decline on Thursday [3] - Standard Lithium Ltd (NYSE:SLI) shares declined 17.3% to $4.45 in pre-market trading after pricing a $130 million underwritten public offering [3] - Almonty Industries Inc (NASDAQ:ALM) slipped 16.4% to $7.11 in pre-market trading after a 12% dip on Thursday [3] - Mesoblast Ltd (NASDAQ:MESO) declined 13.7% to $15.63 in pre-market trading [3] - Jumia Technologies AG – ADR (NYSE:JMIA) shares fell 13.2% to $10.31 in pre-market trading [3] - Terawulf Inc (NASDAQ:WULF) shares fell 13.1% to $12.05 after reporting the pricing of $3.2 billion of senior secured notes [3] - Diginex Ltd (NASDAQ:DGNX) shares slipped 13.1% to $14.45 after an 18% decline on Thursday [3] - Aeluma Inc (NASDAQ:ALMU) shares fell 12.1% to $16.46 in pre-market trading [3] - Compass Diversified Holdings (NYSE:CODI) declined 11.7% to $6.60 in pre-market trading after an 8% gain on Thursday [3] - Integra Resources Corp (NYSE:ITRG) fell 11.3% to $2.89 in pre-market trading [3] - Forward Industries Inc (NASDAQ:FORD) fell 10.8% to $22.00 in pre-market trading [3] - Bruker Corp (NASDAQ:BRKR) declined 10.3% to $34.25 in pre-market trading [3] - Inter & Co Inc (NASDAQ:INTR) fell 10% to $8.04 in pre-market trading [3] - Hut 8 Corp (NASDAQ:HUT) fell 8.5% to $44.59 after a 10% dip on Thursday [3] - Bitdeer Technologies Group (NASDAQ:BTDR) fell 8.2% to $23.75 in pre-market trading [3] - CleanSpark Inc (NASDAQ:CLSK) fell 7.5% to $18.49 in pre-market trading [3] - Kratos Defense & Security Solutions Inc (NASDAQ:KTOS) fell 5.3% to $83.96 in pre-market trading [3]

Group 1 - Mesoblast Limited's product Ryoncil (remestemcel-L-rknd) received a permanent Healthcare Common Procedure Coding System (HCPCS) J-Code (J3402) from the US Medicare & Medicaid Services, effective October 1 [1][2] - The assignment of the J-Code is a significant commercial milestone, providing a standardized billing pathway that facilitates reimbursement by Medicare, Medicaid, and commercial payers, thus improving patient access to Ryoncil [2][3] - Ryoncil is the first mesenchymal stromal cell product approved by the US FDA for any indication and is specifically approved for pediatric patients aged 2 months and older with steroid-refractory acute graft-versus-host disease [3][4] Group 2 - Mesoblast develops allogeneic cellular medicines aimed at treating severe inflammatory conditions, utilizing a proprietary technology platform based on mesenchymal lineage cells [3][4] - The company operates in multiple regions, including Australia, the US, Singapore, and Switzerland, focusing on regenerative medicine products [4]

Market Outlook - Ryan Detrick, chief market strategist at Carson Group, anticipates a strong end-of-year rally despite historically weak periods in late September and early October [1] - The market has experienced five consecutive months of gains, which historically leads to an average decline in October, suggesting a potential break for investors [1] - Q4 typically shows a median return of nearly 6% when the market has been up for five months prior, indicating bullish sentiment [1] Investment Strategy - Detrick expressed a desire for a mild correction of 4-6%, viewing it as a healthy market adjustment [2] - Current market indicators include low put-to-call ratios and a significant inflow of $58 billion into US equity funds, the highest this year [2] - Anticipated volatility around Jewish holidays and early October may present buying opportunities, driven by strong earnings and consumer performance [2] Company Highlights Monopar Therapeutics Inc. (NASDAQ:MNPR) - Achieved a 3-month performance of 100.82% as of October 10, with an average upside potential of 20.70% [7][8] - Raymond James raised the price target from $80 to $142, maintaining a Strong Buy rating, indicating confidence in the company's future performance [8] - Reported a net loss of $2.5 million for Q2 2025, an increase from a net loss of $1.7 million in Q2 2024, with cash reserves of $53.3 million to support operations through December 2026 [9] Mesoblast Limited (NASDAQ:MESO) - Recorded a 3-month performance of 64.01% as of October 10, with an average upside potential of 56.16% [11] - The company received a permanent J-Code for its product Ryoncil, enhancing billing and reimbursement pathways, which is a significant commercial milestone [12] - Ryoncil is the first FDA-approved mesenchymal stromal cell product for pediatric patients with steroid-refractory acute graft-versus-host disease, expanding its market potential [13][14]

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]

Company Overview - Mesoblast Limited is a global leader in developing allogeneic cellular medicines for inflammatory diseases [3][5] - The company is focused on treating severe and life-threatening inflammatory conditions using its proprietary mesenchymal lineage cell therapy technology [3][5] Financial Performance - For the quarter ended September 30, 2025, Mesoblast reported gross revenue of US$21.9 million from Ryoncil sales, marking a 66% increase compared to the previous quarter [1] - The gross to net adjustment for Ryoncil sales remained consistent with prior periods [1] Product Information - Ryoncil (remestemcel-L-rknd) is the first FDA-approved mesenchymal stromal cell (MSC) product for any indication and is specifically approved for children under age 12 with steroid-refractory acute graft-versus-host disease (SR-aGvHD) [2][4] - The company is developing Ryoncil for additional inflammatory diseases, including SR-aGvHD in adults and biologic-resistant inflammatory bowel disease [5] Market and Adoption - The adoption of Ryoncil has been positively influenced by reimbursement from both commercial and government payers [3] - A permanent J-Code assigned by the Centers for Medicare and Medicaid Services (CMS) became active on October 1, which is expected to further enhance adoption [3] Intellectual Property - Mesoblast has a robust global intellectual property portfolio with over 1,000 granted patents or patent applications, providing commercial protection expected to extend through at least 2041 in major markets [6] Manufacturing Capabilities - The company utilizes proprietary manufacturing processes to produce industrial-scale, cryopreserved, off-the-shelf cellular medicines that are planned to be readily available to patients worldwide [7]

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]