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IMAAVY™ (nipocalimab-aahu) showed greater sustained disease control versus approved FcRn blockers for generalized myasthenia gravis (gMG) at multiple timepoints over 24 weeks in newly published indirect treatment comparison (ITC)
Prnewswire· 2025-06-23 11:32
Core Insights - Johnson & Johnson announced new data from an indirect treatment comparison (ITC) showing that IMAAVY (nipocalimab-aahu) provides consistent and sustained disease control in adults with generalized myasthenia gravis (gMG) compared to other approved FcRn blockers [1][2][4] Company Overview - IMAAVY received U.S. FDA approval for a broad population of gMG patients, including those who are anti-AChR and anti-MuSK antibody positive, as well as pediatric patients aged 12 and older [1][4] - The company is committed to helping patients with chronic autoantibody conditions and continues to research the potential impact of IMAAVY [4][10] Treatment Efficacy - The ITC included data from the pivotal Phase 3 Vivacity-MG3 study, demonstrating that IMAAVY showed comparable onset of symptom relief at Week 1 and statistically significant improvements in MG-ADL scores at multiple timepoints up to 24 weeks [2][5][9] - IMAAVY exhibited significantly greater mean improvements in MG-ADL scores compared to other FcRn blockers, with notable differences observed at Weeks 8-24 [5][8] Regulatory and Market Position - IMAAVY is approved in the U.S. for adult and pediatric patients with gMG, and a Marketing Authorisation Application (MAA) has been submitted to the European Medicines Agency (EMA) for approval in Europe [4][10] - The ITC methodology used in the analysis adheres to global health technology assessment standards, providing valuable comparative data for regulatory agencies and medical guideline committees [4][7] Patient Population and Disease Context - Myasthenia gravis affects an estimated 700,000 people worldwide, with approximately 100,000 individuals in the U.S. living with gMG [6][9] - The disease predominantly affects women and can manifest in pediatric patients, with a significant portion of cases diagnosed in girls [6][9]
JNJ Down 6% in 3 Months: How to Play the Stock Amid Various Challenges
ZACKS· 2025-05-22 14:11
Core Viewpoint - Johnson & Johnson (J&J) is facing multiple challenges including declining sales in its MedTech segment, loss of exclusivity for its drug Stelara, and ongoing talc lawsuits, while also navigating a volatile macroeconomic environment [1][2][26] Company Strengths and Weaknesses - J&J's diversified business model is a significant strength, operating through pharmaceuticals and medical devices with over 275 subsidiaries, which helps it withstand economic cycles [4] - The separation of its Consumer Health business into Kenvue allows J&J to focus on its core pharmaceutical and medical device operations [5] Innovative Medicine Unit - J&J's Innovative Medicine unit is experiencing growth, with sales increasing by 4.4% in Q1 2025 despite the loss of exclusivity for Stelara [6] - The company anticipates generating over $57 billion in sales from the Innovative Medicines segment in 2025, with expected growth of 5-7% from 2025 to 2030 [7] - J&J has identified 10 new products with potential peak sales of $5 billion, including cancer drugs and pipeline candidates [8] Patent Expiration and Sales Impact - The loss of U.S. patent exclusivity for Stelara in 2025 is expected to significantly impact sales, which were $10.36 billion in 2024, with a projected decline of 33.7% in Q1 2025 [9][10] - The introduction of biosimilars is anticipated to further erode Stelara's sales throughout 2025 [11] MedTech Segment Challenges - J&J's MedTech sales are facing headwinds, particularly in the Asia Pacific region, with challenges from China's volume-based procurement program and competitive pressures [12][13] - No improvement is expected in the Asia Pacific region for 2025, with ongoing impacts from the VBP program [13] Legal Issues - J&J is dealing with over 62,000 lawsuits related to its talc-based products, which allege that these products contain asbestos [14] - A bankruptcy court recently rejected J&J's proposed plan to settle these lawsuits, forcing the company to revert to traditional legal proceedings [15] Stock Performance and Valuation - J&J's stock has outperformed the industry year-to-date, rising 6.8% compared to a 2.7% decline in the industry [16] - The stock is reasonably priced with a price/earnings ratio of 14.25, slightly below the industry average of 14.79 [19] Future Outlook - J&J considers 2025 a "catalyst year" for growth, expecting operational sales growth to accelerate in the second half of the year [24] - The company has a promising R&D pipeline and has recently made acquisitions to strengthen its market position [25]
VDC+VBench双榜第一!强化学习打磨的国产视频大模型,超越Sora、Pika
机器之心· 2025-05-06 04:11
机器之心发布 机器之心编辑部 随着 Deepseek 等强推理模型的成功,强化学习在大语言模型训练中越来越重要,但在视频生成领域缺少探索。复旦大学等机构将强化学习引入到视频生成领域, 经过强化学习优化的视频生成模型,生成效果更加自然流畅,更加合理。并且分别在 VDC(Video Detailed Captioning)[1] 和 VBench [2] 两大国际权威榜单中斩获 第一。 视频细粒度文本描述 视频细粒度文本描述模型(video detailed caption)为视频生成模型提供标签,是视频生成的基础。复旦大学等机构提出了 Cockatiel 方法 [3],该方法在权威的 VDC(Video Detailed Captioning 视频细粒度文本描述评测集)榜单上获得第一名,超过了包括通义千问 2-VL、VILA1.5、LLaVA-OneVision,Gemini-1.5 等在内的 多个主流视频理解多模态大模型。 论文标题:Cockatiel: Ensembling Synthetic and Human Preferenced Training for Detailed Video Caption ...
FDA Approves Johnson & Johnson's IMAAVYTM (nipocalimab-aahu) a New Treatment for Myasthenia Gravis (MG), Offering Hope for Families
GlobeNewswire News Room· 2025-04-30 17:42
New York, April 30, 2025 (GLOBE NEWSWIRE) -- Muscular Dystrophy Association (MDA) applauds the U.S. Food and Drug Administration (FDA) approval of IMAAVYTM (nipocalimab-aahu) for the treatment of people ages 12 and older who are living with antibody positive (AChR+ or MuSK+) generalized myasthenia gravis (gMG). Learn more about this approval in Johnson & Johnson’s news release here. This milestone marks another significant advancement for the more than 100,000 people living with gMG in the U.S. gMG is a chr ...