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Karyopharm Therapeutics(KPTI) - 2025 Q3 - Earnings Call Presentation
2025-11-03 13:00
Clinical Trial Updates - Phase 3 SENTRY试验的顶线数据预计在2026年3月公布[8, 25] - Phase 3 XPORT-EC-042子宫内膜癌试验的顶线数据预计在2026年中期公布[8, 67] - 评估SPd治疗复发性多发性骨髓瘤患者的3期全球研究(XPORT-MM-031/EMN29)的顶线数据预计在2026年上半年公布[70, 73] - SENTRY (XPORT-MF-034) 是一项针对JAKi初治骨髓纤维化患者,Selinexor联合Ruxolitinib的3期试验,已于2025年9月完成患者招募,共353名患者[23, 24] Commercial Performance - 2025年第三季度,美国XPOVIO净产品收入为3200万美元,比2024年第三季度的2950万美元增长8.5%[37] - 公司重申2025年全年净产品收入指导范围为1.1亿美元至1.2亿美元[37, 54] - 社区环境持续驱动约60%的美国整体净产品收入[37] Financial Highlights - 2025年第三季度总收入为4400万美元,高于2024年第三季度的3880万美元[51] - 预计现有流动资金,在计入2025年10月8日宣布的融资交易的影响后,足以支持公司计划运营至2026年第二季度[53] - 研发和SG&A费用预计为2.35亿美元至2.45亿美元[54] Myelofibrosis Market Opportunity - Selinexor联合Ruxolitinib疗法在美国市场可能达到每年约10亿美元的净销售额峰值[41, 43] - 约75%的患者有意愿接受联合治疗[42]
Karyopharm Therapeutics(KPTI) - 2025 Q2 - Earnings Call Presentation
2025-08-11 12:00
August 11, 2025 Second Quarter 2025 Financial Results & Business Update On Today's Call • Welcome Brendan Strong, SVP, Investor Relations and Corporate Communications • Overview Richard Paulson, President and Chief Executive Officer • Pipeline Update Dr. Reshma Rangwala, Chief Medical Officer and Head of Research • Commercial Highlights Sohanya Cheng, Chief Commercial Officer and Head of Business Development ©2025 KARYOPHARM THERAPEUTICS INC. 2 • Financial Results and Guidance Lori Macomber, Chief Financial ...
European Commission approves Johnson & Johnson's subcutaneous DARZALEX® (daratumumab)-based quadruplet regimen for the treatment of patients with newly diagnosed multiple myeloma, regardless of transplant eligibility
GlobeNewswire News Room· 2025-04-07 09:32
Core Insights - The European Commission has approved an indication extension for DARZALEX® (daratumumab) subcutaneous formulation in combination with bortezomib, lenalidomide, and dexamethasone for newly diagnosed multiple myeloma patients [1][3] - The Phase 3 CEPHEUS study demonstrated significant improvements in minimal residual disease (MRD)-negativity rate, progression-free survival, and complete response rates compared to standard care [1][4] Company Overview - Janssen-Cilag International NV, a subsidiary of Johnson & Johnson, has been a leader in multiple myeloma treatment for over 20 years, with daratumumab becoming a foundational therapy used in over 618,000 patients globally [6][7] - The company aims to provide access to daratumumab-based regimens for all patient populations, regardless of age or fitness, marking a critical step towards achieving a functional cure for multiple myeloma [3][6] Clinical Study Findings - The CEPHEUS study involved 395 patients with newly diagnosed multiple myeloma who were ineligible for stem cell transplantation, comparing daratumumab-VRd to standard VRd [4][5] - At a median follow-up of 59 months, the MRD-negativity rate was 60.9% for daratumumab-VRd versus 39.4% for VRd, with a significant odds ratio of 2.37 [1][4] - The study also reported a 43% reduction in the risk of progression or death with daratumumab-VRd compared to VRd, with median progression-free survival not reached for daratumumab-VRd [1][4] Safety Profile - The safety profile of daratumumab-VRd aligns with known safety profiles for daratumumab SC and VRd, with common Grade 3/4 adverse events including neutropenia (44.2% vs 29.7% for VRd) and thrombocytopenia (28.4% vs 20.0% for VRd) [2][4]