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艾伯维(ABBV.US)Rinvoq斑秃疗法达后期临床主要终点 拟递交监管申请
智通财经网· 2025-08-22 06:34
艾伯维强调,此次试验结果与UP-AA临床项目首次平行研究的数据高度吻合,进一步验证了Rinvoq在斑 秃治疗领域的潜力。 目前该公司正推进相关监管申报工作,若获批上市,这款药物有望为全球数百万严重斑秃患者提供新的 治疗选择。 智通财经APP获悉,艾伯维(ABBV.US)周四宣布,其研发的斑秃治疗药物Rinvoq(upadacitinib)在两项关 键后期试验中达成主要目标。试验分别测试了每日15毫克和30毫克两种剂量方案,结果显示,用药24周 后,15毫克组有45.2%的患者实现至少80%的头皮毛发再生,30毫克组这一比例提升至55%,而安慰剂 组仅1.5%的患者达到类似效果。 除头皮毛发再生外,试验还验证了次要疗效终点:患者眉毛和睫毛的改善情况显著,且部分受试者头皮 毛发覆盖率超过90%。 安全性方面,两种剂量组的不良事件发生率与该药物已获批适应症的表现一致,其中15毫克组严重不良 事件发生率为1.9%,30毫克组为1.8%,均略高于安慰剂组的0.7%,但整体风险仍属可控范围。 ...
AbbVie Announces Positive Topline Results from Second Phase 3 UP-AA Trial Evaluating Upadacitinib (RINVOQ®) for Alopecia Areata
Prnewswire· 2025-08-21 12:30
35.2% and 45.8% of patients treated with upadacitinib 15 mg and 30 mg, respectively, reached 90% or more scalp hair coverage (SALT ≤ 10), compared to 0.7% of patients receiving placebo at week 24 (p<0.001).1 Additional key secondary endpoints that were met included percentage of subjects with improvements in eyebrows and eyelashes, as well as the percentage of subjects with complete scalp hair coverage (SALT=0) with both doses of upadacitinib at week 24.1 "People living with AA often face considerable uncer ...
AbbVie Rises 11.5% in a Month: Buy, Hold or Sell the Stock?
ZACKS· 2025-08-20 14:42
Core Insights - AbbVie's stock has increased by 11.5% in the past month due to strong second-quarter performance, beating earnings and sales estimates with earnings of $2.97 per share, a 12.1% year-over-year increase [1][2] Financial Performance - Revenues reached $15.42 billion, reflecting a 6.6% year-over-year increase, driven by strong sales of key drugs such as Rinvoq and Skyrizi, alongside contributions from newer drugs like Ubrelvy and Elahere [2][3] - AbbVie raised its revenue and EPS guidance for 2025, expecting adjusted EPS between $11.88-$12.08 and total revenues around $60.5 billion, up from previous estimates [3] Product Performance - AbbVie has successfully launched new immunology drugs, Skyrizi and Rinvoq, which are expected to replace declining sales from Humira, generating combined sales of $11.6 billion in the first half of 2025 [5][7] - Skyrizi and Rinvoq are projected to achieve combined sales exceeding $25 billion in 2025 and over $31 billion by 2027, with Skyrizi annualizing at nearly $18 billion and Rinvoq at over $8 billion [8][9] Oncology and Neuroscience Growth - The oncology segment generated $3.3 billion in the first half of 2025, a 4.2% year-over-year increase, supported by new drug launches and the addition of antibody-drug conjugates [11][13] - Sales in the neuroscience portfolio increased by 20.3% to nearly $5 billion, driven by products like Botox Therapeutic and newer migraine treatments [14] Acquisition Strategy - AbbVie has engaged in over 30 M&A transactions since early 2024, focusing on immunology, oncology, and neuroscience to enhance its early-stage pipeline [15][16] - Recent acquisitions include Capstan Therapeutics, adding a potential first-in-class CAR-T therapy to its immunology pipeline [16] Challenges and Market Dynamics - Humira's sales have declined over 50% in the first half of 2025 due to biosimilar erosion, with expectations of continued decline as more plans adopt exclusionary formularies [17] - Sales of Juvederm fillers have also decreased by 22.2% in the first half of 2025, impacted by macroeconomic challenges and weakened consumer sentiment [18] Stock Performance and Valuation - AbbVie's stock has gained 19.3% year-to-date, outperforming the industry and S&P 500 [19] - The stock trades at a price/earnings ratio of 15.31, higher than the industry average of 14.46, indicating a relatively high valuation compared to some peers [22] Future Outlook - AbbVie anticipates returning to mid-single-digit revenue growth in 2025, driven by the performance of Skyrizi and Rinvoq, with no significant loss of exclusivity events expected for the remainder of the decade [28][29]
AbbVie Completes Acquisition of Capstan Therapeutics
Prnewswire· 2025-08-19 12:55
Acquisition adds a potential first-in-class in vivo targeted lipid nanoparticle (tLNP) anti-CD19 CAR-T therapy candidate for B cell-mediated autoimmune diseases as well as a proprietary tLNP platform designed to deliver RNA payloads, such as mRNA, capable of engineering specific cell types in vivo NORTH CHICAGO, Ill., Aug. 19, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) announced today that it has completed its acquisition of Capstan Therapeutics. With the completion of the acquisition, Capstan is now a part o ...
SkinMedica® Unveils Its Newest Hydration Hero
Prnewswire· 2025-08-19 12:00
Core Viewpoint - Allergan Aesthetics, a subsidiary of AbbVie, has launched the HA5® Hydra Collagen Hydrating Foaming Cleanser, which is designed to provide hydration and thorough cleansing for the skin, enhancing the effectiveness of subsequent skincare products [1][2]. Product Overview - The HA5® Hydra Collagen Hydrating Foaming Cleanser features the proprietary HA5® Hydra Collagen Complex, which includes five forms of hyaluronic acid and vegan hydra collagen, aimed at delivering instant hydration [1][2]. - The cleanser is formulated with 100% naturally derived amino acid-based surfactants and Pea Peptides, making it suitable for dry and sensitive skin [2]. - Clinical studies indicate that the cleanser can effectively remove makeup and impurities while boosting skin hydration by 30% when used with the HA5® Hydra Collagen Replenish + Restore Hydrator [2][3]. Market Positioning - Allergan Aesthetics emphasizes innovation in aesthetic medicine, positioning the HA5® line as a benchmark for advanced skin hydration solutions [2]. - The new cleanser is part of a broader portfolio that includes products from SkinMedica®, SKINVIVE by JUVÉDERM®, and DiamondGlow®, all aimed at providing superior hydration [2]. Expert Endorsement - Dr. Tiffany J. Libby, a board-certified dermatologist, endorses the product, highlighting its dual function of cleansing and hydrating while respecting the skin barrier [3]. Pricing and Availability - The HA5® Hydra Collagen Hydrating Foaming Cleanser is priced at $48 and is available for purchase on SkinMedica.com [3].
If You'd Invested $1,000 in AbbVie Stock 10 Years Ago, Here's How Much You'd Have Today
The Motley Fool· 2025-08-18 09:59
Core Viewpoint - AbbVie has significantly outperformed the broader market since its split from Abbott Laboratories in 2013, driven by strong sales from its immunology drug Humira and subsequent products Skyrizi and Rinvoq [1][2][4]. Performance Analysis - AbbVie's shares have increased by 353.3% over the past decade, translating to an annual growth rate of 16.3%, outperforming the S&P 500 [4]. - A $1,000 investment in AbbVie 10 years ago would be worth $4,530.75, compared to $3,690.99 for the S&P 500 [4]. Key Products - Humira was the cornerstone of AbbVie's success, achieving peak sales of $22.1 billion before losing patent protection in the U.S. in 2023 [7]. - AbbVie is transitioning to Skyrizi and Rinvoq, which are expected to generate combined sales of $31 billion by 2027, surpassing Humira's peak sales [9]. Future Outlook - The company has a robust pipeline and has expanded its product offerings through acquisitions, including the $63 billion acquisition of Allergan in 2020 [10]. - AbbVie is actively developing new products, such as GUB014295 for weight management, to ensure continued growth [11]. Dividend Performance - AbbVie has increased its dividend payouts by 221.6% over the past decade and has a forward yield of 3.2%, significantly higher than the S&P 500's average of 1.3% [12]. - The company is recognized as a Dividend King, with 53 consecutive years of payout increases [12]. Investment Potential - AbbVie is positioned to continue delivering strong returns, particularly for investors who reinvest dividends [13].
不止药王“易主”,上半年全球药品销售TOP50解析:疫苗疲软、国产上榜、前列腺癌“王牌药”仍坚挺
Mei Ri Jing Ji Xin Wen· 2025-08-14 08:52
Core Insights - The global pharmaceutical sales ranking for the top 50 drugs has been revealed, with Novo Nordisk's semaglutide surpassing Merck's Keytruda to become the new sales champion, achieving over $16.6 billion in sales [1][3] - Eli Lilly's tirzepatide shows significant growth potential with a sales increase of 121.3%, reaching nearly $15 billion [1][2] - The entry of domestic innovative drugs into the ranking marks a notable shift in the competitive landscape [1] Group 1: Top Selling Drugs - Semaglutide, including Ozempic, Rybelsus, and Wegovy, generated sales of $16.632 billion, with a year-on-year growth of 29.8% [3][4] - Tirzepatide achieved sales of $14.734 billion, with a remarkable growth rate of 121.3% [3][8] - Dulaglutide, another Eli Lilly product, saw a decline in sales, highlighting the competitive pressures in the market [3][4] Group 2: Vaccine Sales Decline - Three vaccine products in the top 50 experienced sales declines, despite a favorable competitive landscape [4][5] - Gardasil 9, a nine-valent HPV vaccine, saw a nearly 50% drop in revenue [5][6] - The decline in vaccine sales is attributed to reduced government subsidies and market saturation [6][7] Group 3: Emerging Drugs and Growth - Over 70% of drugs in the ranking maintained positive sales growth, with only seven drugs exceeding a 30% growth rate [8] - Enzalutamide, approved for 13 years, continues to show over 30% growth, with sales projected to reach $4.6 billion in 2022 [9][10] - The competitive landscape for enzalutamide is expected to intensify as its core patent expires in 2026 [10]
AbbVie: H1 2025 Earnings Strengthen Case For Targeting Gilgamesh Acquisition
Seeking Alpha· 2025-08-12 20:59
Core Insights - AbbVie Inc. reported Q2 2025 earnings showcasing strong performance from Skyrizi and Rinvoq, which generated $6.4 billion in global sales, representing 41% of the company's total revenues for the quarter [1] Financial Performance - Skyrizi and Rinvoq's combined sales of $6.4 billion highlight their significant contribution to AbbVie's revenue stream [1] - The performance of these products indicates a robust market presence and potential for continued growth in the future [1] Product Analysis - Both Skyrizi and Rinvoq are demonstrating strong market performance, suggesting their effectiveness and acceptance in the healthcare market [1]
AbbVie Announces $195 Million Investment to Expand Active Pharmaceutical Ingredient Manufacturing in the U.S.
Prnewswire· 2025-08-12 17:00
Core Viewpoint - AbbVie is investing $195 million to expand its active pharmaceutical ingredient (API) production in North Chicago, Illinois, as part of a broader commitment to invest over $10 billion in the U.S. over the next decade [1][8]. Group 1: Investment and Expansion - The new API facility will enhance AbbVie's chemical synthesis capabilities in the U.S., supporting the production of current and next-generation medicines in neuroscience, immunology, and oncology [2][8]. - Construction of the new facility is set to begin in fall 2025, with full operational status expected by 2027 [3][8]. - This investment is part of AbbVie's long-term commitment to Illinois, where the company employs over 11,000 individuals [4][5]. Group 2: Economic Impact - The expansion will support more than 6,000 American jobs across 11 manufacturing sites and create additional jobs at suppliers throughout the U.S. [3][8]. - The investment is seen as a reinforcement of Illinois' biomanufacturing ecosystem and is expected to bolster the state's workforce and infrastructure [5]. Group 3: Strategic Importance - AbbVie's CEO emphasized that this expansion is crucial for maintaining U.S. leadership in pharmaceutical innovation and delivering impactful next-generation medicines [3]. - The investment aligns with AbbVie's mission to address serious health issues and medical challenges across key therapeutic areas [6].
北美医药生物-一图胜千言-A picture is worth a thousand words
2025-08-11 02:58
Summary of Key Points from the Conference Call Industry Overview - The conference call focuses on the **Biopharma** industry in **North America** with a comprehensive analysis of the **US drug market** as per **IQVIA Rx** data [1][6]. Core Insights - The **Total Prescription Year-over-Year (YoY) growth** for the week ending August 1, 2025, was reported at **+2.8%**, an increase from **+1.7%** the previous week and **+2.6%** over the past 12 weeks [1][6]. - For the week ended August 1, the **US total market weekly TRx YoY change** was **+2.8%**, compared to **+0.9%** a year ago. The **rolling 4-week TRx YoY** was **+2.9%** and the **rolling 12-week TRx YoY** was **+2.6%** [2]. Company-Specific Developments - **Bristol Myers Squibb (BMY)**: - The drug **Cobenfy** was approved for schizophrenia on September 26, 2024. The current scripts are approximately **2,010** for the week, up from **1,950** the previous week. To meet 2025 consensus expectations, Cobenfy's TRx needs to track at **~2-3x** the volumes from recent schizophrenia launches [3]. - The consensus estimate for Cobenfy has decreased from **$196 million** to **$171 million**, implying that approximately **129K TRx** are required to meet these estimates [3]. - **Vertex Pharmaceuticals (VRTX)**: - The drug **Journavx** was approved for acute pain on January 30, 2025, with current scripts at approximately **6,800**, up from **6,430** the previous week. It is noted that hospital scripts, which account for about **35%** of total scripts, are not captured by IQVIA [4]. - To achieve a sales target of **$78 million**, approximately **345K total scripts** are needed, assuming a **$225 net price per script** [4]. - **Gilead Sciences (GILD)**: - The launch comparison for **Yeztugo** (lenacapavir) shows current TRx at approximately **210**, down from **300** the previous week. The injectable formulation accounts for **50%** of total TRx [5]. Additional Insights - The **extended unit (EUTRx)** weekly YoY growth was reported at **+1.9%**, which is below the TRx YoY growth [2]. - The **sequential weekly TRx growth** was **-0.1%**, an improvement from **-1.2%** the week before [2]. - The **biopharma industry view** is categorized as **attractive**, while the major pharmaceuticals industry view is **in-line** [7]. Notable Trends - The **momentum of top outpatient drugs** indicates varying performance across different companies, with notable declines in some established drugs like **Humira** (AbbVie) showing a **-40%** YoY change, while newer drugs like **Mounjaro** (Eli Lilly) and **Zepbound** (Eli Lilly) show significant growth rates of **69%** and **257%** respectively [24]. Conclusion - The conference call highlights a positive trend in the US drug market with specific growth in total prescriptions. However, individual company performance varies significantly, with newer drugs showing strong growth potential while established drugs face declines. The insights provided can guide investment decisions in the biopharma sector.