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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]
永安期货股指早报-20250623
Group 1: Market Performance - A-shares continued to decline, with the Shanghai Composite Index closing down 0.07% at 3359.9 points, the Shenzhen Component down 0.47%, and the ChiNext Index down 0.83%[1] - The Hong Kong market saw the Hang Seng Index rise by 1.26% to 23530.48 points, with the Hang Seng Tech Index up 0.88% and the Hang Seng China Enterprises Index up 1.38%[1] - The total market turnover in Hong Kong was 2224.23 million HKD[1] Group 2: Economic Indicators and Federal Reserve Actions - Federal Reserve Governor Waller indicated that a rate cut could occur as early as July, suggesting that the current benchmark interest rate is 1.25 to 1.5 percentage points above the neutral level[1] - The U.S. stock market showed mixed results, with the Dow Jones up 0.08%, the S&P 500 down 0.22% at 5967.84 points, and the Nasdaq down 0.51%[1] Group 3: Geopolitical Events - The U.S. military conducted airstrikes on three Iranian nuclear facilities, with President Trump threatening larger attacks if Iran does not reach a peace agreement[1] - Iran's response included a vow to retain all options for retaliation, indicating heightened tensions in the region[1]
Investigational combination of first-in-class bispecifics TALVEY® and TECVAYLI® shows deep and durable responses in heavily pretreated multiple myeloma patients with extramedullary disease
Prnewswire· 2025-06-15 07:15
Group 1 - The Phase 2 RedirecTT-1 study results show a high overall response rate (ORR) of 78.9% in patients with triple-class exposed relapsed/refractory multiple myeloma (RRMM) who have extramedullary disease (EMD) [1][2][3] - The investigational combination of TALVEY® (talquetamab-tgvs) and TECVAYLI® (teclistamab-cqyv) demonstrates deep and durable responses, with 54.4% of patients achieving complete response or better [2][3][4] - The study enrolled 90 patients, with 84.4% being triple-class refractory and 35.6% penta-drug refractory, indicating a heavily pre-treated population [2][3][4] Group 2 - The combination therapy resulted in 61% of patients being progression-free and alive at one year, with a median follow-up of 13.4 months [2][3][4] - Among responders, 66.2% maintained their response, with a median duration of response of 13.8 months [2][3][4] - The safety profile of the combination was consistent with previous reports, with low rates of discontinuation due to adverse events [2][3][4] Group 3 - TALVEY® received FDA approval in August 2023 as a first-in-class GPRC5D-targeting bispecific antibody for RRMM patients who have received at least four prior lines of therapy [3][4] - TECVAYLI® was approved in October 2022 as an off-the-shelf antibody for RRMM patients who have received at least four prior lines of therapy [5][6] - Both TALVEY® and TECVAYLI® have transformed treatment options for relapsed or refractory multiple myeloma, addressing significant unmet needs in this patient population [2][3][5]
Johnson & Johnson's dual-targeting CAR T-cell therapy shows encouraging first results in large B-cell lymphoma
Prnewswire· 2025-06-13 15:00
Phase 1b study suggests a promising safety profile and highlights the potential of a novel dual-targeting CD19/CD20 CAR T in patients with relapsed or refractory disease75-80% complete response rate among evaluable patients at the recommended Phase 2 dose  MILAN, June 13, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) announced today the first clinical data from an ongoing Phase 1b study for JNJ-90014496 (JNJ-4496), an investigational dual-targeting anti-CD19/CD20 bispecific autologous chimeric antigen ...
张瑜:全球化“退潮”下美股海外业务的隐忧——七问美股海外经营状况
一瑜中的· 2025-06-13 14:57
文 : 华创证券研究所副所长 、首席宏观分析师 张瑜(执业证号:S0360518090001) 联系人:殷雯卿 (19945767933) 核心观点 在美国关税政策的环境下,全球"去美元化"的讨论愈演愈烈。本文从美股上市公司海外业务的角度出发,刻画了美股公司海外业务的画像: ① 大企业海外业务占比 3 成,高于小企业( 20% )。 ② 科技( 51% )、材料( 38% )、医疗( 35% )、通讯业( 34% )的海外业务敞口最大,其中科技与通讯业市值占标普 500 的近一半;这些行业中通讯业 海外业务增速自 2017 年以来普遍高于整体收入增速,是对海外业务依赖最高的行业。 ③ 标普 500 权重股的海外收入占比普遍高于行业均值,同时海外业务的利润率也高于本土(如 2024 年苹果海外收入占比 57% ,行业均值 51% ,海外利润率 42% ,整体利润率 32% ;亚马逊海外收入占比 39% ,行业均值 27% ,海外利润率 17% ,整体利润率 11% );即美国巨头企业对海外经营的依赖度较高。 ④ 披露中国业务的标普 500 企业中,科技与通讯业( 25% )的中国营业收入比重高于整体均值( 17 ...
Should You Forget Johnson & Johnson and Buy This Magnificent High-Yield Stock Instead?
The Motley Fool· 2025-06-13 08:25
Several years ago I bought shares of 3M (MMM -1.73%) even though it was in the middle of a major class-action lawsuit. I believed the industrial giant would survive the legal issues, which it has. But I was surprised at how difficult it was for me to stick it out, given the lack of information from the company on the legal front.I think Johnson & Johnson (JNJ 0.90%) is a great company, but I see visions of 3M when I look at it -- which is why I opted for the high-yield stock of a competitor. Here's why you ...
New results for Johnson & Johnson's bleximenib demonstrate promising antileukemic activity in combination with venetoclax and azacitidine for acute myeloid leukemia
Prnewswire· 2025-06-12 15:00
Bleximenib, an investigational selective menin inhibitor, shows potential as combination therapy for the treatment of relapsed or refractory AML and newly diagnosed, intensive chemo-ineligible AML Phase 1b data show low rate of differentiation syndrome and no cardiac safety signal of QTc prolongationMILAN, June 12, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced new Phase 1b data showing encouraging antileukemic activity and a promising safety profile for bleximenib (JNJ-75276617) in comb ...
Johnson & Johnson (JNJ) Presents at Goldman Sachs 46th Annual Global Healthcare Conference Transcript
Seeking Alpha· 2025-06-11 21:54
Johnson & Johnson (NYSE:JNJ) Goldman Sachs 46th Annual Global Healthcare Conference Call June 11, 2025 3:20 PM ET Company Participants Tom Cavanaugh - Company Group Chairman for North America Innovative Medicine Conference Call Participants Asad Haider - Goldman Sachs Group, Inc., Research Division Asad Haider We're just right about at time, so let's get started. Tail end of day 3 of our conference, saving the best for last. Very welcome to Tom Cavanaugh, group -- Company Group Chairman, North American Inno ...
Johnson & Johnson (JNJ) FY Conference Transcript
2025-06-11 20:20
Johnson & Johnson (JNJ) FY Conference June 11, 2025 03:20 PM ET Speaker0 America. And, we are front and center wanting to work with the administration. And there's areas that I would say organizationally and and from an industry perspective, think we could have a substantial impact. And and some of it, we're encouraged by the administration recognizes it. Some of them, the middlemen, focusing on the PBM reform, 340B reform, areas where we can bring the cost and drive it down to the patient so they can actua ...
Why Johnson & Johnson (JNJ) is a Top Momentum Stock for the Long-Term
ZACKS· 2025-06-11 14:56
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