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Here's How AMGN Benefits From FDA Nod to Uplizna in Myasthenia Gravis
ZACKS· 2025-12-12 14:25
Core Viewpoint - Amgen's drug Uplizna has received FDA approval for treating generalized myasthenia gravis (gMG) in adults with specific antibody profiles, marking a significant advancement in the treatment landscape for this rare disease [1][10]. Group 1: Drug Approval and Efficacy - Uplizna is the first CD19-targeted B-cell therapy approved for gMG, providing a twice-yearly dosing option, which is a notable advantage over existing therapies that require more frequent administration [2][10]. - The FDA's approval is based on data from the phase III MINT study, demonstrating strong efficacy in gMG patients [3][10]. - This approval represents the second for Uplizna in 2023 and its third overall in the U.S., following approvals for immunoglobulin G4-related disease and neuromyelitis optica spectrum disorder [4][10]. Group 2: Market Position and Competition - Uplizna enters a competitive market for gMG therapies, competing with argenx's Vyvgart/Vyvgart Hytrulo, J&J's Imaavy, and UCB's Rystiggo [6][10]. - While Uplizna, Vyvgart/Vyvgart Hytrulo, and Rystiggo are approved for adults, Imaavy has a broader age eligibility, being approved for patients aged 12 years and older [8]. Group 3: Financial Performance and Valuation - Amgen's shares have outperformed the industry year to date, indicating strong market performance [9][10]. - The company is currently trading at a price/earnings (P/E) ratio of 14.67, which is below the industry average of 16.59, suggesting a potential undervaluation [12]. - Earnings per share (EPS) estimates for 2025 and 2026 have increased in the past 30 days, reflecting positive market sentiment [13].
2 Top Dividend Stocks to Buy and Hold
The Motley Fool· 2025-11-30 09:05
Core Viewpoint - The article emphasizes the potential rewards for investors who remain committed to dividend-paying healthcare stocks, specifically highlighting Bristol Myers Squibb and Johnson & Johnson as strong candidates for income investing. Group 1: Bristol Myers Squibb (BMY) - Bristol Myers Squibb has faced challenges due to patent expirations, particularly for its cancer drug Opdivo and anticoagulant Eliquis, which will lose exclusivity by the end of the decade [3][4] - The company has launched new products, including a subcutaneous version of Opdivo and Reblozyl for anemia, which are expected to drive sales growth [4][6] - In Q3, total revenue increased by 3% year-over-year to $12.2 billion, with the growth portfolio reporting an 18% increase in sales to $6.9 billion [6] - Bristol Myers Squibb has a strong pipeline with numerous products in development, particularly in oncology, including BNT327 in collaboration with BioNTech [7] - The stock offers a forward dividend yield of 5.1%, and the company has increased its payouts by 63.2% over the past decade, making it attractive for income-seeking investors [8] Group 2: Johnson & Johnson (JNJ) - Johnson & Johnson has encountered patent cliffs, legal challenges, and government drug-price negotiations but has still performed well, with Q3 sales rising by 6.8% year-over-year to $24 billion [9] - The company is focused on innovation to navigate challenges, recently launching Imaavy for myasthenia gravis and the AI-powered Virtuguide System for medtech applications [10][12] - Johnson & Johnson boasts a strong balance sheet with the highest credit rating available, indicating its ability to manage obligations and legal issues [13] - The company is recognized as a Dividend King, having raised its payouts for 63 consecutive years, making it a reliable income stock [14][15]
J&J Up Around 17% in 3 Months: Should You Buy, Sell or Hold the Stock?
ZACKS· 2025-11-25 13:26
Core Insights - Johnson & Johnson's (JNJ) stock has increased by 16.7% over the past three months, primarily driven by strong third-quarter 2025 results that exceeded expectations in both revenue and earnings, along with an upward revision of sales guidance for the year [1][9]. Group 1: Company Performance - J&J's Innovative Medicine unit has shown consistent growth, with sales rising 3.4% in the first nine months of 2025 despite the loss of exclusivity for its product Stelara, which previously accounted for around 18% of the unit's sales [5][16]. - The Innovative Medicine segment achieved over $15 billion in sales for the second consecutive quarter, supported by key drugs such as Darzalex, Erleada, and Tremfya, as well as new products like Carvykti and Tecvayli [5][8]. - J&J anticipates accelerated growth in the Innovative Medicine segment in 2026, driven by both existing and newly launched products [6]. Group 2: Pipeline and Regulatory Developments - J&J has made significant progress in its pipeline, achieving key clinical and regulatory milestones, including approvals for new treatments like Inlexzo and Imaavy [7]. - The company believes that ten of its new products in the Innovative Medicine segment have the potential to generate peak sales of $5 billion [11]. Group 3: MedTech Segment and Strategic Moves - J&J's MedTech business has shown improvement, particularly due to acquisitions in the cardiovascular sector, and plans to separate its Orthopaedics franchise into a standalone company to focus on high-growth markets [12][13]. - The company expects better growth in the MedTech segment in 2026, driven by the adoption of new products and a focus on higher-growth markets [14]. Group 4: Challenges and Legal Issues - J&J faces challenges in China due to the volume-based procurement (VBP) program, which is impacting sales [15]. - The company is dealing with over 73,000 lawsuits related to its talc-based products, which allege health risks, and has recently shifted back to the traditional tort system after a failed bankruptcy strategy [19][20]. Group 5: Stock Performance and Valuation - J&J's stock has outperformed the industry, rising 42.5% year-to-date compared to a 16.0% increase in the industry [22]. - The stock is currently trading at a price/earnings ratio of 18.04, which is higher than the industry average of 17.04 and above its five-year mean of 15.65 [26]. Group 6: Earnings Estimates - The Zacks Consensus Estimate for J&J's 2025 earnings has increased slightly from $10.86 to $10.87 per share, while the estimate for 2026 has risen from $11.37 to $11.48 [29].
Johnson & Johnson (JNJ)’s Dividend Legacy: How a Healthcare Giant Built a Record of Consistent Dividends
Yahoo Finance· 2025-09-16 14:09
Group 1 - Johnson & Johnson (JNJ) is recognized as one of the 13 Best Consistent Dividend Stocks to buy now [1] - The company has a diversified business model, with key growth drivers including cancer treatments like Darzalex and Erleada, and immunology drug Remicade [2] - New product introductions include Imaavy for myasthenia gravis and TAR-200, an investigational treatment for bladder cancer awaiting regulatory feedback [2] Group 2 - Johnson & Johnson is a significant player in the medical device sector, with long-term growth potential in its robotic-assisted surgery system, Ottava, currently in clinical trials [3] - The company is a Dividend King, boasting 63 years of dividend growth, with a current quarterly dividend of $1.30 per share and a dividend yield of 2.92% as of September 12 [3]
J&J Gains FDA Approval for Inlexzoh, Strengthens Pipeline Momentum
ZACKS· 2025-09-10 16:06
Core Insights - Johnson & Johnson (JNJ) received FDA approval for TAR-200, a treatment for high-risk non-muscle invasive bladder cancer, to be marketed as Inlexzoh, which allows for extended local delivery of medication into the bladder [1][2] - The approval is based on data from the phase IIb SunRISe-1 study and targets patients with Bacillus Calmette-Guérin (BCG)-unresponsive NMIBC [1] - J&J's pipeline includes several promising candidates and recently approved drugs, positioning the company for growth through the latter half of the decade [3][8] Product Pipeline and Approvals - Nipocalimab, approved as Imaavy, is being evaluated for various immune-mediated conditions and is considered to have pipeline-in-a-product potential [4] - A new drug application for icotrokinra, targeting moderate-to-severe plaque psoriasis, was filed in July, with potential to set a new standard of care [5] - J&J's new cancer drugs, including Carvykti, Tecvayli, and Talvey, generated $1.3 billion in sales in the first half of 2025 [6] Market Position and Competition - J&J's oncology sales account for approximately 40% of its pharmaceutical revenues, reflecting a 21.1% increase in the first half of 2025 [9][10] - Competitors in the oncology space include AstraZeneca, Merck, Pfizer, and Bristol-Myers, with AstraZeneca's oncology sales comprising around 43% of total revenues [9][10][12] Financial Performance - J&J's shares have outperformed the industry, rising 25.3% year-to-date compared to a 1.1% increase for the industry [13] - The company's price/earnings ratio stands at 15.79, higher than the industry average of 14.71, indicating a relatively expensive valuation [14] - The Zacks Consensus Estimate for 2025 earnings has increased from $10.64 to $10.86 per share over the past 60 days [18]
J&J Gears Up for Some Key New Drug Approvals and Launches
ZACKS· 2025-09-03 15:06
Core Insights - Johnson & Johnson (J&J) has a strong R&D pipeline focusing on immunology, oncology, and neuroscience, with significant clinical and regulatory milestones achieved in 2025 to drive growth through the decade [1][8] Pipeline Candidates - Key pipeline candidates include nipocalimab, TAR-200, and icotrokinra, with all three either approved by the FDA or in regulatory review [2] - Nipocalimab, approved as Imaavy in the U.S. for generalized myasthenia gravis, is under EU review and is being evaluated for various immune-mediated conditions [3] - TAR-200 is under priority review in the U.S. for high-risk non-muscle invasive bladder cancer, with a potential launch later this year [4] - Icotrokinra, an oral targeted peptide inhibitor, is being evaluated for moderate-to-severe plaque psoriasis and ulcerative colitis [4] Oncology Portfolio - J&J's new cancer drugs, including Carvykti, Tecvayli, and Talvey, generated $1.3 billion in sales in the first half of 2025, contributing significantly to top-line growth [5][10] - Oncology sales now account for approximately 40% of J&J's pharmaceutical revenues, with a 21.1% increase in the first half of 2025 [9] Strategic Acquisitions - The acquisition of Intra-Cellular Therapies added Caplyta to J&J's neuroscience portfolio, which is approved for schizophrenia and depression in bipolar disorders [6][10] - J&J believes that ten of its new products/pipeline candidates have the potential to deliver peak sales of $5 billion [6] Market Position and Competition - J&J is well-positioned in the oncology space, competing with major players like AstraZeneca, Merck, Pfizer, and Bristol-Myers [9] - The company is expanding the labels of currently marketed products to include new indications, with key approvals expected this year [7] Financial Performance - J&J's shares have outperformed the industry, rising 26.1% year-to-date compared to a 1.4% increase for the industry [14] - The company's shares trade at a price/earnings ratio of 15.90, higher than the industry average of 14.78 [15] - The Zacks Consensus Estimate for 2025 earnings has increased from $10.62 to $10.86 per share over the past 60 days [18]
Massive Headwinds Are on the Horizon for Pharmaceutical Stocks, but Here Are 2 That Could Weather the Storm
The Motley Fool· 2025-08-17 23:23
Core Insights - The article discusses how Johnson & Johnson and Novartis are positioned to navigate patent expirations for key products while maintaining strong financial performance Group 1: Johnson & Johnson - Johnson & Johnson is facing biosimilar competition for its best-selling product Stelara, leading to a significant revenue drop of 42.7% year-over-year to $1.7 billion in Q2 [4] - Despite the decline in Stelara's sales, the company's overall revenue grew by 5.8% year-over-year to $23.7 billion, and it raised both top- and bottom-line guidance for the year [5] - The company has a diversified pharmaceutical portfolio with growth drivers including cancer medicines Darzalex and Erleada, and newer products like Imaavy and TAR-200 [6][7] - Johnson & Johnson is also a leader in the medical device industry, with potential growth from its robotic-assisted surgery system, Ottava [7] - The company has a strong dividend history, having raised payouts for 62 consecutive years, positioning it as a reliable long-term investment [8] Group 2: Novartis - Novartis is preparing for generic competition for its heart failure medication Entresto, which generated $4.6 billion in sales in the first half of the year, with nearly 52% from the U.S. [9] - Despite the impending patent cliff for Entresto, Novartis expects high-single-digit revenue growth for the year, indicating strong overall performance [10] - The company has a diverse portfolio with several blockbuster products, seven of which generated over $1 billion in revenue each in the first half of 2025 [11] - New products like Vanrafia, approved in April, are expected to contribute to future growth, with peak sales estimates of $1.5 billion [12] - Novartis is involved in patent litigation regarding generic versions of Entresto, which could result in financial compensation if it wins [13] - The company has a solid dividend track record, having raised payouts for 28 consecutive years, making it an attractive option for dividend-seeking investors [14]