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U.S. FDA Approves Expanded Indication for AbbVie's MAVYRET® (Glecaprevir/Pibrentasvir) as First and Only Treatment for People with Acute Hepatitis C Virus
Prnewswire· 2025-06-11 16:31
Core Insights - AbbVie announced FDA approval for MAVYRET® (glecaprevir/pibrentasvir) to treat adults and pediatric patients aged three years and older with acute or chronic hepatitis C virus (HCV) infection, marking it as the first DAA therapy approved for eight-week treatment of acute HCV with a 96% cure rate [1][3][5] - The approval aligns with global clinical guidelines advocating for universal treatment of HCV, aiming to eliminate the disease by 2030, although many high-income countries, including the U.S., are not on track to meet this goal until after 2050 [1][4][5] - The Phase 3 M20-350 study demonstrated MAVYRET's efficacy and safety, enrolling 286 treatment-naïve adult patients, with the primary endpoint being the sustained virological response (SVR12) at 12 weeks post-treatment [2][4] Company Insights - AbbVie has treated over one million patients with HCV through MAVYRET, recognizing the ongoing need for effective treatment options for acute infections [1][3] - The FDA granted Breakthrough Therapy Designation for MAVYRET, expediting its development and review process due to its potential to significantly improve treatment outcomes compared to existing therapies [1][7] - The company emphasizes the importance of early treatment to prevent progression to chronic disease and associated complications, such as cirrhosis and liver cancer [1][3][4] Industry Insights - HCV is a highly infectious disease that can lead to severe liver-related complications if untreated, with the U.S. projected to incur approximately $120 billion in medical costs over the next decade due to chronic liver disease linked to untreated HCV [1][3] - Current public health goals aim for the elimination of HCV by 2030, with a focus on increasing testing and treatment accessibility [1][4][5] - The majority of adverse events reported in the MAVYRET study were mild to moderate, indicating a favorable safety profile for the treatment [2][4]
AbbVie Inc. (ABBV) Presents at Goldman Sachs 46th Annual Global Healthcare Conference Transcript
Seeking Alpha· 2025-06-11 05:36
Core Insights - AbbVie is actively engaging with the administration regarding drug pricing policies and is optimistic about the productive nature of these discussions [3][4]. Group 1: Company Overview - AbbVie is represented by its entire management team at the Goldman Sachs 46th Annual Global Healthcare Conference [1]. - Robert A. Michael, CEO & Director, emphasizes the importance of addressing affordability and access to medicines while maintaining innovation [4]. Group 2: Industry Environment - The pharmaceutical sector is currently facing uncertainties related to drug pricing policies, particularly following the Most Favored Nation Executive Order [3]. - The administration's engagement with the pharmaceutical industry is seen as a positive development, indicating a willingness to discuss various topics related to drug pricing and access [4].
AbbVie (ABBV) FY Conference Transcript
2025-06-10 16:20
AbbVie (ABBV) FY Conference Summary Industry Overview - The pharmaceutical sector is currently facing challenges related to drug pricing and affordability, with ongoing discussions with the administration aimed at balancing access to medicines and preserving innovation [1][4][7]. - The U.S. is noted to pay significantly more for innovative medicines compared to Europe, which pays about half as much [2]. Core Company Insights Drug Pricing and Administration Engagement - AbbVie is encouraged by productive conversations with the administration regarding drug pricing and affordability [1][5]. - The company is actively engaging in trade negotiations to address disparities in drug pricing and reimbursement timelines, particularly in the EU [2][3]. Financial Performance and Guidance - AbbVie reported strong business momentum, exceeding revenue guidance by $550 million in Q1 2025, with significant contributions from immunology, neuroscience, oncology, and aesthetics [19][21]. - The company raised its full-year sales guidance to approximately $59.7 billion, marking a new peak shortly after the HUMIRA loss of exclusivity [21][22]. Product Performance - The ex-HUMIRA business grew approximately 23% year-over-year on an operational basis, indicating robust performance across various franchises [20][23]. - SKYRIZI and RINVOQ are capturing significant market share in immunology, with one out of every two new switching patients in Crohn's disease opting for these treatments [38][39]. Pipeline and Future Growth - AbbVie has a strong pipeline with a focus on early-stage opportunities, having executed over 25 early-stage deals since the beginning of the previous year [33][34]. - The company is investing in differentiated therapies across various therapeutic areas, including immunology, oncology, and neuroscience, with a particular emphasis on addressing unmet needs in obesity and Parkinson's disease [36][57]. Competitive Landscape - The competitive environment in immunology is intensifying, with new entrants like Tremfya and Stellara biosimilars impacting market dynamics. However, AbbVie maintains a strong position due to the efficacy of SKYRIZI and RINVOQ [38][44]. - The introduction of oral IL-23s is expected to carve out a niche for certain patients, but AbbVie believes that its biologics will continue to dominate the market for more severe cases [47][49]. Aesthetics and Consumer Sentiment - The aesthetics market is showing signs of stabilization, with AbbVie recovering market share in the toxin segment. The company anticipates that the approval of a new fast-acting toxin will further stimulate market growth [75][77]. Key Takeaways - AbbVie is well-positioned for growth with a robust pipeline and strong financial performance, despite challenges in the pharmaceutical landscape related to pricing and competition [15][16]. - The company is focused on maintaining its R&D leadership while navigating regulatory changes and market dynamics [7][30].
Have Skyrizi and Rinvoq Successfully Saved AbbVie From Humira LoE?
ZACKS· 2025-06-10 14:05
Core Insights - AbbVie anticipates a return to strong revenue growth in 2025, following the loss of U.S. exclusivity for Humira, which saw a nearly 50% year-over-year sales decline to $1.12 billion in Q1 2025 [1][7] - The ex-Humira platform experienced over 21% year-over-year growth in Q1 2025, driven by the performance of newer immunology drugs, Skyrizi and Rinvoq [2][7] - AbbVie raised its sales guidance by approximately $900 million, now targeting $24.7 billion in combined sales from Skyrizi and Rinvoq for 2025 [3][7] Ex-Humira Growth - Skyrizi and Rinvoq are leading the growth in AbbVie's ex-Humira revenue, particularly in the inflammatory bowel disease (IBD) market, which includes ulcerative colitis (UC) and Crohn's disease (CD) [2][3] - Strong market growth and the potential for new indications for Rinvoq are expected to further drive sales [3] Competitive Landscape - The immunology market is highly competitive, with Johnson & Johnson's Stelara and Tremfya as key competitors, especially after Stelara lost U.S. exclusivity [4] - Eli Lilly is also expanding its immunology portfolio with the recent FDA approval of Omvoh for UC and CD indications [5] Valuation and Performance - AbbVie shares have outperformed the industry year-to-date, trading at a price/earnings (P/E) ratio of 14.48, slightly below the industry average of 15.12 [6][9] - The Zacks Consensus Estimate for 2025 earnings has slightly decreased from $12.30 to $12.28 per share, while the estimate for 2026 has increased from $13.97 to $14.05 [10]
太能涨了,港股创新药指数指数年内狂飙60%,17只ETF涨超40%!本轮“吃药”行情强势上涨逻辑是什么?
Jin Rong Jie· 2025-06-10 13:03
总体来看,港股年内涨幅超过40%的生物医药类ETF有17只,汇添富、银华、华泰柏瑞、万家、广发、 富国基金旗下相关产品年内涨幅均超55%。 今年以来,国产创新药行情火爆远超市场预期。 数据显示,截至6月9日,万得创新药指数年内涨近30%,而港股创新药指数更是飙升近60%,创下近年 新高。 | 陸号 | 证券代码 | 证券简称 | 区间涨跌幅 | | | --- | --- | --- | --- | --- | | | | | [区间首日] 本年初 [区间롭日] 2025-6-9 | | | | | | [車位] %] | | | | 866076.WI | 万得创新药指数 | | 27.6209 | | 2 | 931787CNY00.CSI | 港股创新药(CNY) | | 56.4975 | 值得一提的是,本轮"吃药"行情与过往医药牛市存在显著差异: 涨幅龙头集中于创新药企业,且港股表现尤为强劲。南下资金持续涌入带来的估值抬升,使得重仓港股 的医药主题QDII基金表现亮眼。 截至6月9日,跨境ETF涨幅榜中,年内涨超40%的基金均为与生物医药主题相关基金: | | | | 售股生物医药类ETF年内核心情 ...
Can New Cancer Drug Emrelis Drive AbbVie's Oncology Franchise?
ZACKS· 2025-06-06 14:15
Core Insights - AbbVie has received FDA approval for Emrelis, marking a significant advancement in its oncology franchise, specifically for treating non-squamous non-small cell lung cancer (NSCLC) with high c-Met overexpression [1][2] Group 1: Product Development and Market Position - Emrelis is AbbVie's first internally developed solid tumor drug and its first lung cancer therapy, providing a unique advantage as the only approved treatment for this patient population [2][8] - c-Met overexpression is present in 25% of advanced EGFR wild-type NSCLC patients, with approximately half of these patients exhibiting high c-Met overexpression, which is associated with poor prognosis [2] - AbbVie anticipates starting to record sales for Emrelis in Q3 2025, with estimated sales of $28 million for the current year [3] Group 2: Competitive Landscape - While AbbVie has a first-mover advantage with Emrelis, competitors like AstraZeneca and Regeneron Pharmaceuticals are also developing drugs targeting similar indications [4][8] - Regeneron is conducting mid-stage studies for its investigational ADC, davutamig, which targets two distinct MET epitopes [5] - AstraZeneca is in phase I studies for its investigational ADC, AZD9592, aimed at c-MET-driven solid tumors, although it currently lags behind AbbVie in this specific indication [6] Group 3: Financial Performance and Valuation - AbbVie shares have outperformed the industry year to date, reflecting positive market sentiment [7] - The company's shares trade at a price/earnings (P/E) ratio of 14.37, slightly below the industry average of 14.95, but higher than many other large drugmakers [10] - The Zacks Consensus Estimate for AbbVie's 2025 earnings has slightly decreased from $12.30 to $12.28 per share, while the estimate for 2026 has increased from $13.97 to $14.05 [11]
Contact The Gross Law Firm by June 3, 2025 Deadline to Join Class Action Against Cerevel Therapeutics Holdings, Inc. (ABBV)
GlobeNewswire News Room· 2025-06-04 17:00
Core Viewpoint - The Gross Law Firm has issued a notice to shareholders of Cerevel Therapeutics Holdings, Inc. regarding a class action lawsuit related to alleged misleading statements and omissions during a secondary stock offering, which may have artificially deflated the stock price prior to a merger announcement with AbbVie Inc. [1][4] Group 1: Class Action Details - The class period for the lawsuit is from October 11, 2023, to August 1, 2024, and includes shareholders who sold or held shares during this timeframe [3]. - Shareholders are encouraged to register for the class action, with a deadline for lead plaintiff appointment set for June 3, 2025 [5]. Group 2: Allegations Against Cerevel - The complaint alleges that Cerevel's October 16, 2023 secondary stock offering omitted material facts about AbbVie's interest in acquiring Cerevel at a significantly higher price than the offering price of $22.81 per share [4]. - Bain Capital, Cerevel's controlling shareholder, allegedly acquired shares at an artificially depressed price while possessing nonpublic information about AbbVie's acquisition interest, leading to a windfall of over $120 million when AbbVie agreed to acquire Cerevel for $45 per share [4]. Group 3: Legal Representation - The Gross Law Firm is a nationally recognized class action law firm dedicated to protecting investors' rights and ensuring responsible business practices [6].
Profit From the Silver Tsunami: Must-Watch Senior Care & Aging Stocks
ZACKS· 2025-06-04 15:35
Demographic Trends - The global population is aging rapidly, with life expectancies increasing and birth rates declining, leading to a demographic imbalance in both developed and emerging economies [1] - By 2030, one in six individuals globally will be over 60, and by 2050, this figure is expected to reach 2.1 billion, with 80% residing in low- and middle-income countries [2] Healthcare Market Dynamics - The global geriatric care market was valued at approximately $1.2 trillion in 2025, up from around $1 trillion in 2022, driven by the rising prevalence of chronic conditions among older adults [3] - There is a growing demand for pharmaceuticals, medical devices, home-based care, and digital health solutions tailored for aging populations [3] Company Strategies - Healthcare companies like Boston Scientific, AbbVie, Amgen, and Dexcom are enhancing operational efficiency to expand their presence in the Seniors & Aging Demographics domain [4] - Pharmaceutical companies are focusing on developing treatments for chronic conditions prevalent in older adults, particularly in immunology, oncology, and neurodegenerative diseases [5] Investment Opportunities - The Healthcare Real Estate Investment Trust (Healthcare REIT) sector is gaining attention, with companies like Community Healthcare Trust and CareTrust REIT focusing on specialized healthcare real estate for the aging population [6] - Digital health solutions, AI-driven diagnostics, and home-based monitoring systems are creating new revenue opportunities for healthcare firms [5] Company Highlights - Boston Scientific has developed devices like the WATCHMAN and SYNERGY systems, catering to the needs of elderly patients [8] - AbbVie is expanding its focus on the aging demographic through strategic acquisitions and partnerships, including the acquisition of Aliada Therapeutics for Alzheimer's treatment [10][11] - Amgen is advancing its R&D pipeline with a focus on elderly-targeted medicines, including osteoporosis treatments and obesity drugs [13][14][15] - Dexcom is enhancing its continuous glucose monitoring systems for seniors, including the launch of the Stelo system, which is designed for ease of use [16][17]
June's Dividend Kings: 3 Ideal Buys In 25 "Safer" Dogs
Seeking Alpha· 2025-06-04 12:13
Group 1 - The leader of The Dividend Dog Catcher investing group shares at least one new dividend stock idea weekly, focusing on yield or extraordinary financial circumstances [1] - All investment ideas are archived and available for review after the weekly announcement [1] Group 2 - The article emphasizes that it is for informational and educational purposes only and should not be interpreted as investment advice [2] - It clarifies that past performance does not guarantee future results and that no specific investment recommendations are provided [3]
3 Cheap Dividend Growth Stocks to Buy Right Now
The Motley Fool· 2025-06-04 09:50
Core Viewpoint - Dividend growth stocks are ideal long-term investment options as they provide good payouts and potential for capital appreciation, helping to mitigate inflation effects [1] Group 1: Investment Opportunities - ExxonMobil has increased its annual dividend for 42 consecutive years, currently yielding 3.76%, which is significantly higher than the S&P 500 average of 1.3% and its own three-year average of 3.4% [4][5] - Verizon Communications offers the highest yield on the list at 6.2%, which is above its five-year average of 5.8%, despite a 22% decline in stock price over the past five years [6][7] - AbbVie, classified as a Dividend King with over 50 years of annual increases, currently yields 3.5% and has a strong portfolio in various therapeutic areas [10][12] Group 2: Financial Metrics - ExxonMobil trades at less than 14 times its trailing earnings, indicating a relatively cheap valuation [4] - Verizon trades at less than 11 times its earnings, with an estimated free cash flow of at least $17.5 billion, significantly exceeding its annual dividend payout of $11 billion [8][9] - AbbVie trades at an earnings multiple of around 80, but based on future profit estimates, it trades at about 15 times its expected earnings [11]