NEW YORK, Nov. 24, 2025 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided a trading update, together with a comprehensive operational overview, as part of the Chief Executive’s Annual General Meeting (AGM) address. For the quarter ending December 31, 2025, management expects gross revenue of more than US$30.0 million from sales of Ryoncil® (remestemcel-L-rknd). This represents more than 37% increase on the U ...

In the TRANSCEND MCL trial, 82.7% of patients responded to Breyanzi, with 71.6% of patients achieving complete response Nov 24, 2025 5:00 PM Eastern Standard Time Bristol Myers Squibb Receives Approval from the European Commission to Expand Use of CAR T Cell Therapy Breyanzi for Relapsed or Refractory Mantle Cell Lymphoma Share Breyanzi demonstrated sustained clinical benefit, with 50.8% of patients still in response at 24 months based on TRANSCEND MCL trial results PRINCETON, N.J.--(BUSINESS WIRE)--Bristol ...

编辑丨王多鱼 排版丨水成文 近十年来，中国科学家在 细胞出版社 （Cell Press） 旗下期刊上的论文数量实现了跨越式增长，研究主题从单一学科拓展到交叉前沿，合作网络从国内延伸至全 球，展示了中国科研在原创性、系统性与开放性上的全面提升。无论是在生命科学、物质科学，还是在能源、医学与人工智能等交叉领域，中国科学家的声音都 越来越清晰、越来越有分量。 2024 年，中国科学家的研究产出数量持续提升，以中国机构为第一完成单位、发表在 细胞出版社 （Cell Press） 旗下研究型期刊上的研究论文数量继续快速增 长， 总发文量达到 2446 篇，较上一年增加了 17.6%，是 2020 年发表量的近 4 倍 。 近日， 细胞出版社 （Cell Press） 评选出了" 细胞出版社 2024 中国年度论文 "， 生命科学领域、物质科学领域、医学领域、交叉学科领域和可持续发展五个领 域，每个领域 10 篇，共计 50 篇，全部入选论文详见： 细胞出版社2024中国年度论文奖重磅公布：十年见证中国科研前进之路！ 本文将介绍入选 " 细胞出版社 2024 中国年度论文 "的 医学 领域 10 篇论文，排名不分先后。生 ...

Vericel (NasdaqGM:VCEL) FY Conference Summary Company Overview - **Company**: Vericel Corporation - **Industry**: Biotechnology, specifically in regenerative medicine and cell therapy Key Financial Highlights - **Q3 Revenue**: Achieved record revenue of approximately **$67.5 million** [4] - **MACI Revenue**: Contributed about **$56 million**, reflecting a **25% growth** [4] - **Burn Care Revenue**: Recorded its strongest quarter with approximately **$12 million** [4] - **Adjusted EBITDA**: Increased by **70%** to about **$17 million**, achieving a **25% margin** [5] - **GAAP Net Income**: Positive at approximately **$5 million** [5] - **Cash Generation**: Generated roughly **$20 million** in operating and free cash flow [5] Market and Product Insights - **Total Addressable Market (TAM)**: Identified a **60,000-patient TAM** for MACI [8] - **Market Segmentation**: - Key growth drivers include patella and larger defects, making up about **one-third** of the market [9] - Smaller defects, particularly in the femoral condyles (2-4 sq cm), represent about **two-thirds** of the market, with low penetration currently [10] - **Surgeon Adoption**: Growth in surgeon adoption is crucial, with expectations for continued growth in MACI usage among surgeons [12] Strategic Initiatives - **Salesforce Expansion**: - Expansion to approximately **100 territories** from **75**, with hiring ahead of schedule [26] - Focus on increasing surgeon activation and deeper penetration in existing accounts [29] - **International Expansion**: - Plans to target the U.K. for MACI rollout, with potential launch in **2027** [46] - New manufacturing facility in Burlington, MA, set to support both U.S. and international standards [46] Product Development and Pipeline - **MACI Ankle Study**: On track for initiation in Q4 [6] - **Arthro Training**: Surgeons trained in Arthro are showing higher biopsy growth rates compared to non-trained surgeons [18] - **Trochlear Defects**: Notable increase in utilization for trochlear defects, indicating a potential growth area [15] Financial Outlook - **2026 Growth Expectations**: Anticipated strong growth driven by MACI, with a cautious outlook for 2024 at around **20% growth** [34] - **Margin Guidance**: Projected **74% gross margin** and **26% adjusted EBITDA margin** for the current year, with expectations for margin expansion moving forward [49] Challenges and Considerations - **Burn Care Variability**: Epicel's revenue has shown variability, with efforts to stabilize and grow the burn care franchise [37] - **Nexabrid Utilization**: Despite achieving **70 P&T approvals**, utilization has been slower than expected due to workflow and training challenges [42] Conclusion - **Overall Positioning**: Vericel is well-positioned for continued growth with strong financial performance, strategic initiatives in place, and a focus on expanding its market presence both domestically and internationally. The company is optimistic about its future trajectory, particularly with the anticipated contributions from its expanded Salesforce and new product offerings.

Core Viewpoint - 博瑞医药 plans to invest 50 million yuan in Suzhou Geek Gene Technology Co., Ltd., acquiring a 12.8015% stake in the company, which focuses on single-cell sequencing services and immune cell therapy development [1][2] Investment Details - The investment will increase 博瑞医药's stake in 极客基因 from 4.0816% to 12.8015%, with the new capital being priced at 114.3903 yuan per registered capital [3] - 极客基因 is valued at approximately 461 million yuan, reflecting a 581.35% increase in valuation [2][3] - 博瑞医药's investment decision is based on the potential of 极客基因's technology and market prospects, particularly its GK01 cell injection product, which received IND approval [3][4] Financial Performance - 极客基因 reported revenues of 4.47 million yuan and 3.58 million yuan for 2024 and the first three quarters of 2025, respectively, with net losses of 38.58 million yuan and 39.54 million yuan [4] - As of September 30, 2025, 极客基因's total assets were approximately 81.11 million yuan, with total liabilities of about 35.16 million yuan, resulting in an asset-liability ratio of 43.35% [4] 博瑞医药's Financial Situation - 博瑞医药's revenue for the first three quarters of 2025 was approximately 874 million yuan, a year-on-year decrease of 10.5%, with net profit declining by 71.64% to about 50.32 million yuan [6] - The decline in performance is attributed to changes in demand for antiviral products and fluctuations in market competition [6] Strategic Decisions - 博瑞医药 is pursuing a Hong Kong IPO to broaden its financing channels and enhance its international market presence, following the termination of a planned A-share private placement [7] - The decision to go public in Hong Kong aligns with the company's long-term strategic goals and is independent of the previous A-share fundraising efforts [7]

Core Insights - Bayer has received European Commission approval for elinzanetant, branded as Lynkuet, to treat moderate to severe vasomotor symptoms (VMS) associated with menopause or adjuvant endocrine therapy related to breast cancer [1][7] - The approval is based on positive results from the OASIS program, which demonstrated a favorable safety profile and met all primary and key secondary endpoints [2][7] - Bayer's shares have increased by 62.1% year to date, significantly outperforming the industry average gain of 14.3% [2] Product Details - Elinzanetant is a dual neurokinin-targeted therapy, specifically an NK-1 and NK-3 receptor antagonist, and is the only hormone-free treatment for moderate to severe VMS [4] - VMS affects up to 80% of women during menopause, with approximately 40% of women in Europe reporting moderate to severe symptoms [4][5] - Lynkuet is already approved in the UK and the US for treating VMS associated with menopause [5] Portfolio Expansion - The approval of Lynkuet enhances Bayer's pharmaceutical portfolio, adding to the momentum of existing drugs like Nubeqa and Kerendia [2][9] - Bayer's Pharmaceuticals division is experiencing growth, compensating for declines in sales of Xarelto, which is co-developed with Johnson & Johnson [8] - Bayer is also working on label expansions for Nubeqa and Kerendia, which could further drive sales growth [9] Pipeline Development - Bayer is making progress in its pipeline, with a new drug application for gadoquatrane accepted for review in the US and China [10] - The company is expanding its capabilities in cell and gene therapy through acquisitions of BlueRock and AskBio, targeting various diseases [11]

Summary of Artiva Biotherapeutics Conference Call Company Overview - **Company**: Artiva Biotherapeutics (NasdaqGM: ARTV) - **Industry**: Cell Therapy for Autoimmune Diseases Key Points and Arguments Differentiation in Cell Therapy - Artiva is positioned at an inflection point to create significant value in cell therapy for autoimmune diseases, particularly through its AlloNK product, which offers an off-the-shelf solution with a tolerability profile similar to biologics [2][3][4] Clinical Trials and Data - Over 100 patients have been treated, including trials in non-Hodgkin's lymphoma (NHL) and Hodgkin's lymphoma, showing high rates of complete responses and durability [6][7] - The ongoing trials focus on five indications: rheumatoid arthritis (RA), myositis, scleroderma, lupus, and Sjogren's syndrome, with 32 patients treated so far [7][9] - Safety data indicates a clean profile with no cases of cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), or graft-versus-host disease (GVHD) [10][13] Mechanism of Action - The objective is to achieve deep B cell depletion in tissues, which is crucial for clinical response in autoimmune diseases [27] - Artiva's NK cell therapy is non-genetically modified, utilizing monoclonal antibodies for targeting, which simplifies the manufacturing process and enhances safety [23][24] Efficacy and Safety Profile - The safety profile is comparable to biologics, with low doses of cyclophosphamide and fludarabine used, leading to minimal adverse events [19][20] - B cell reconstitution begins around six months post-treatment, with a predominance of naive or transitional B cells observed [31] Market Opportunity - The target market for RA includes approximately 150,000-200,000 refractory patients in the U.S., representing a significant opportunity for Artiva to be a first mover in this space [38] - The company aims for a pivotal trial in RA, setting a high bar for efficacy with a target of 50% ACR50 response in patients who have failed multiple therapies [34] Financial Position - As of September, Artiva reported a cash balance of $123 million, providing sufficient runway into Q2 2027 to support ongoing clinical milestones [39] Additional Important Information - The competitive landscape in the deep B cell depletion space is acknowledged, with a focus on unmet needs and standard of care [33] - Artiva's approach is to leverage its clinical data and FDA feedback to expedite the transition to pivotal trials [36][34] This summary encapsulates the critical insights from the conference call, highlighting Artiva Biotherapeutics' strategic positioning, clinical advancements, and market potential in the field of autoimmune disease therapies.

Summary of Nkarta's Conference Call Company Overview - Nkarta is a biotechnology company focused on autoimmune diseases, specifically utilizing CAR-NK (chimeric antigen receptor natural killer) cell therapy targeting CD19, currently in phase I clinical trials for conditions such as lupus nephritis and primary membranous nephropathy [5][6] Key Points and Arguments Clinical Trials and Efficacy - Nkarta is conducting two company-sponsored INDs: one for lupus nephritis and primary membranous nephropathy, and another basket trial for systemic sclerosis, ANCA-associated vasculitis, and myositis [5] - The company has reported a regimen involving preconditioning with fludarabine and cyclophosphamide, leading to deep B-cell depletion, with plans to provide efficacy updates in 2026 [6][8] - The deep B-cell depletion observed with NK cells is comparable to that seen with CAR-T therapies, indicating potential for durable clinical responses [7][8] Competitive Landscape - The competitive environment for patient enrollment in clinical trials has intensified, with various therapies (CAR-T, CAR-NK, bispecifics, etc.) vying for the same patient population in autoimmune diseases [10][11] - Nkarta has increased patient awareness and engagement through community outreach, which has improved enrollment rates [12][14] - The company acknowledges a previous misstep in their approach to lymphodepletion but has since adjusted their strategy to enhance patient safety and enrollment [14][18] Regulatory and Development Updates - Nkarta has harmonized its two Entrust trials, allowing for a more efficient dose escalation process, which will expedite patient enrollment and data generation [39][42] - The FDA has been supportive of Nkarta's approach, allowing for combined trial management and streamlined processes [46][58] Financial Position - As of the end of Q3, Nkarta has over $300 million in cash, providing a runway into 2029, allowing the company to focus on clinical execution without immediate concerns about raising capital [62][64] Future Outlook - The company is optimistic about the potential for CAR-NK therapies to provide long-term drug-free remissions, similar to what has been observed in the autologous CAR-T space [21][22] - Nkarta is positioning itself to be competitive against other modalities, emphasizing the convenience and safety of their off-the-shelf NK cell therapy [29][30] Other Important Insights - There is a growing recognition of the need for deep B-cell depletion to achieve durable responses, with competitors likely to face challenges in achieving similar outcomes without effective lymphodepletion [20][22] - Nkarta's leadership emphasizes the importance of safety and patient-first approaches in their clinical development strategy [18][19] This summary encapsulates the key discussions and insights from Nkarta's conference call, highlighting the company's strategic direction, competitive landscape, and financial health.

Summary of ProKidney Conference Call Company Overview - ProKidney is focused on addressing chronic kidney disease (CKD) in patients, particularly those at risk of requiring dialysis. The company is based in North Carolina and Boston, employing approximately 250 individuals aligned with its mission to keep patients off dialysis [2][3]. Product and Clinical Trials - ProKidney's primary product, rilparencel, is an autologous cell therapy currently in a Phase 3 clinical trial aimed at preserving kidney function in patients with advanced CKD [2][4]. - The company has made significant progress in its clinical studies, overcoming initial manufacturing challenges and achieving Good Manufacturing Practice (GMP) compliance [4][5]. - An accelerated approval pathway has been established with the FDA, allowing for a readout based on eGFR slope, with top-line data expected in Q2 2027 [5][14]. Clinical Study Details - The Phase 3 study is a double-blind, sham-controlled trial conducted at over 60 sites in the U.S., Taiwan, and Mexico, with a primary endpoint of a composite time-to-event measure [13][14]. - The study aims to demonstrate a 1.5 mL per minute per year difference in eGFR progression between treated and sham groups, with a 90% power to detect this difference [14][15]. - Enrollment is progressing well, with over 50% of participants already enrolled [5][17]. Efficacy and Safety Data - In a Phase 2 study (007), rilparencel demonstrated a 78% improvement in kidney function decline in one treatment group, while another group showed a 50% benefit, suggesting a dose-response relationship [5][9]. - Safety measures include strict eligibility criteria to minimize risks associated with kidney biopsies, and the company reports no serious events related to rilparencel [25][26]. Market Opportunity - The addressable market includes 1 to 1.5 million stage 3B and 4 CKD patients with diabetes in the U.S. A 1% market penetration could result in 10,000 to 15,000 patients treated annually [31]. - Rilparencel could potentially save the healthcare system up to $150,000 annually per patient by delaying the need for dialysis [31][32]. - The Medicare budget allocates 7% to manage end-stage kidney disease, indicating a significant financial burden that rilparencel aims to alleviate [36][38]. Financial Position and Future Catalysts - As of September 30, ProKidney has $272 million in cash, sufficient to fund operations through mid-2027 [40]. - Key upcoming catalysts include the Phase 3 data readout in Q2 2027 and additional data on the mechanism of action in the following year [40][41]. Conclusion - ProKidney is positioned in a promising market with a unique product aimed at a significant health issue. The company is on track with its clinical trials and has a solid financial foundation to support its upcoming milestones [41].

Group 1: Company Overview and R&D Progress - The company has a global competitive edge in early research capabilities and a full-chain development and production capacity for plasmids, lentiviruses, and CAR-T cell processes [3][4] - It operates the largest fully automated and intelligent cell commercialization base in the Asia-Pacific region [3] - The company has five innovative drug products and platforms, including CD-7-CAR-T and a unique in vivo lentivirus transfection mechanism for CAR-T generation [3][4] Group 2: Clinical Trials and Product Pipeline - The CD7-CAR-T (PA3-17 injection) has entered critical Phase II clinical trials, with plans to complete patient enrollment within one year and submit a pre-NDA communication application by Q1 2027 [4][5] - The LV009, targeting B-ALL/NHL and autoimmune diseases, has completed preclinical development and is in the investigator-initiated trial (IIT) phase [4] - The company is also advancing the UTAA09 injection for T lymphocyte malignancies and UTAA61 injection for solid tumors, currently in animal testing [4] Group 3: Market Expansion and Strategic Partnerships - The company plans to apply for direct market approval in Belt and Road countries post-product approval and is in discussions with the FDA to use Chinese clinical data for direct registration in the U.S. [5] - It aims to establish business partnerships for overseas expansion, potentially through licensing or collaborative development [5] Group 4: Research and Development Strategy - The company employs a dual approach in drug development, focusing on both independent research and commercial collaborations [6][7] - It has secured exclusive agency agreements for certain products and is actively seeking to integrate leading research teams and technologies into its platform [7] Group 5: Ongoing Research and Future Plans - The LV009 is currently in a dose escalation scheme, with the first patient enrolled and efficacy evaluation expected soon [7] - The PD-1 agonist has shown promising preclinical data and is set to initiate investigator-initiated clinical trials in 2026 [7]