Key Takeaways Amgen acquired Dark Blue Therapeutics for about $840M, strengthening its oncology pipeline.AMGN gains a preclinical small-molecule degrader targeting MLLT1/3 proteins tied to certain AML types.Amgen has no marketed AML therapy, but sells Blincyto for ALL and has early AML bispecifics.Amgen (AMGN) announced that it has acquired U.K.-based private biotech company, Dark Blue Therapeutics, for approximately $840 million.The acquisition will strengthen Amgen’s oncology pipeline by adding Dark Blue’ ...

Core Insights - Amgen reported strong Q3 2025 earnings, with adjusted earnings of $5.64 per share, surpassing the Zacks Consensus Estimate of $5.00, and total revenues of $9.6 billion, exceeding the estimate of $8.9 billion, reflecting a 12% year-over-year increase [2][3] Financial Performance - Total product revenues increased by 12% year-over-year to $9.17 billion, driven by a 14% rise in volume, although partially offset by a 4% decline in pricing [3] - Other revenues rose by 19.3% year-over-year to $420 million, primarily due to higher royalty income [3] - Adjusted operating margin decreased by 2.5 percentage points to 47.1%, with operating expenses increasing by 18% to $5.25 billion [22] Key Product Performance - Prolia revenues reached $1.14 billion, up 9% year-over-year, significantly exceeding the Zacks Consensus Estimate of $911 million [6] - Evenity sales grew by 36% year-over-year to $541 million, surpassing the Zacks Consensus Estimate of $519 million [7] - Repatha generated revenues of $794 million, a 40% increase year-over-year, beating the Zacks Consensus Estimate of $720 million [7] - Biosimilar portfolio sales surged by 52% year-over-year to $775 million [5] Guidance and Outlook - Amgen raised its 2025 revenue and earnings outlook, expecting total revenues between $35.8 billion and $36.6 billion, and adjusted earnings per share in the range of $20.60 to $21.40 [24] - Adjusted operating margin is anticipated to be around 45%, with R&D expenses expected to grow at a mid-20s percentage rate year-over-year [25] Pipeline Developments - Enrollment has been completed in two phase III studies for MariTide, with approximately 5,000 adults enrolled [27] - Ongoing enrollment in two other phase III studies for atherosclerotic cardiovascular disease and heart failure [28]

INCHEON, Korea--(BUSINESS WIRE)-- #Biosimilar--Samsung Bioepis Co., Ltd. today announced the launch of OBODENCEâ"¢ (60 mg pre-filled syringe) and XBRYKâ"¢ (120 mg vial), denosumab biosimilars referencing Prolia and Xgeva. The products will be commercially available in Europe in December 2025 and January 2026, respectively. "We are very thrilled to launch OBODENCE and XBRYK through our direct sales efforts. Osteoporosis remains a major challenge in Europe due to limited treatment options and affordability ch ...

Core Viewpoint - The company, 博安生物, has seen a stock increase of over 4% following the acceptance of its marketing authorization applications for two monoclonal antibody injections in the UK, indicating positive market sentiment and potential growth opportunities [1] Group 1: Product Development - 博安生物's BA6101 (60mg) and BA1102 (120mg) are key products in its global development strategy, targeting orthopedic and oncology fields respectively [1] - The company plans to submit marketing applications for these products to major international regulatory bodies including EMA, FDA, and PMDA [1] Group 2: Market Potential - There is a significant global market potential for 地舒单抗, with projected combined sales of Prolia and Xgeva reaching approximately $6.6 billion in 2024 [1] - The company has established a comprehensive quality management system that meets international standards to support the global commercialization of its products [1]

Core Viewpoint - The company, Boan Biotech (06955), has seen its stock rise over 4% following the acceptance of its marketing authorization applications for two monoclonal antibody injections in the UK, indicating positive market sentiment and potential growth opportunities in the orthopedic and oncology sectors [1] Group 1: Product Development - Boan Biotech announced that its self-developed monoclonal antibody injections, BA6101 (60mg) for orthopedics and BA1102 (120mg) for oncology, have received acceptance from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for marketing authorization [1] - The company considers BA6101 and BA1102 as core products in its global development strategy and plans to submit applications to other international regulatory bodies, including the European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA), and the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan [1] Group 2: Market Potential - There is a broad market outlook for the monoclonal antibody, denosumab, due to extensive clinical demand and significant clinical value, with global sales for Prolia and Xgeva projected to reach approximately $6.6 billion in 2024 [1] - To support its global commercialization goals, the company has established a comprehensive quality management system that meets international standards in China, Europe, the United States, and Japan, ensuring quality assurance for denosumab and future biopharmaceuticals [1]

Core Insights - Amgen reported third-quarter 2025 adjusted earnings of $5.64 per share, exceeding the Zacks Consensus Estimate of $5.00 per share, with a year-over-year earnings increase of 1% driven by higher revenues despite increased operating costs and taxes [1] - Total revenues reached $9.6 billion, surpassing the Zacks Consensus Estimate of $8.9 billion, marking a 12% year-over-year increase [1] Revenue Breakdown - Total product revenues increased by 12% year-over-year to $9.17 billion, with volume growth of 14% offset by a 4% negative impact from pricing [2] - Other revenues amounted to $420 million, reflecting a 19.3% year-over-year increase [2] Key Drug Performance - Evenity sales reached $541 million, up 36% year-over-year, exceeding both the Zacks Consensus Estimate of $519 million and the model estimate of $463.9 million [3] - Repatha generated revenues of $794 million, a 40% year-over-year increase, beating the Zacks Consensus Estimate of $720 million and the model estimate of $672.2 million [3] - Prolia revenues were $1.14 billion, up 9% year-over-year, significantly surpassing the Zacks Consensus Estimate of $911 million and the model estimate of $812.8 million [4] - Xgeva delivered revenues of $539 million, flat year-over-year, but exceeded the Zacks Consensus Estimate of $428 million and the model estimate of $408.6 million [5] - Blincyto sales were $392 million, a 20% increase year-over-year, but missed the Zacks Consensus Estimate of $413 million [7] - Otezla sales were $585 million, up 4% year-over-year, beating the Zacks Consensus Estimate of $582 million but missing the model estimate of $648.2 million [8] - Enbrel revenues declined by 30% year-over-year to $580 million, missing the Zacks Consensus Estimate of $645 million but beating the model estimate of $530.4 million [9] - Tezspire recorded sales of $377 million, a 40% year-over-year increase, exceeding both the Zacks Consensus Estimate of $364 million and the model estimate of $270.6 million [10] Cost and Margin Analysis - Adjusted operating margin decreased by 2.5 percentage points to 47.1%, with adjusted operating expenses rising by 18% to $5.25 billion [14] - R&D expenses increased by 31% year-over-year to $1.89 billion, reflecting ongoing investment in the late-stage pipeline [14] Future Outlook - Amgen raised its 2025 revenue and earnings guidance, expecting total revenues between $35.8 billion and $36.6 billion, and adjusted earnings per share in the range of $20.60 to $21.40 [15] - The company anticipates continued growth from key drugs like Repatha, Evenity, Tezspire, and its biosimilar portfolio, although erosion from biosimilars of Prolia and Xgeva may offset some growth [21] Pipeline Developments - Amgen is advancing its obesity drug MariTide, which has shown strong efficacy in clinical studies, with six global phase III studies currently underway [16][17] - Enrollment has been completed in two phase III studies for MariTide, with ongoing studies for cardiovascular disease and heart failure [18]

Core Insights - Amgen (AMGN) is set to report its third-quarter 2025 results on November 4, with earnings expected to be $5.00 per share and sales at $8.94 billion, reflecting a 14.5% earnings surprise in the last quarter [1][9] Sales Performance - Strong volume growth from products like Evenity, Repatha, and Blincyto is anticipated to drive sales, with consensus estimates for these products at $519 million, $720 million, and $413 million respectively [2] - The company's own estimates for Evenity, Repatha, and Blincyto are slightly lower at $463.9 million, $672.2 million, and $395.5 million respectively [3] - Sales of RANKL antibodies, Prolia, and Xgeva are expected to decline significantly due to patent expirations and the launch of three biosimilars in the U.S. market [4] New Product Contributions - Newer drugs such as Imdelltra, Tavneos, and Tezspire are projected to contribute positively to top-line growth, with consensus estimates for Tezspire and Tavneos at $364 million and $119 million respectively [5] - The company's estimates for Tezspire and Tavneos are $270.6 million and $120.7 million respectively [5] Competitive Pressures - Kyprolis is expected to face continued competitive pressure, with consensus sales estimates at $374 million and the company's estimate at $372.6 million [6] - Enbrel sales are likely to decline due to price reductions, while Otezla is expected to benefit from volume growth, with consensus estimates for Otezla at $582 million and Enbrel at $645 million [6] Recent Acquisitions - Sales of rare disease drugs Tepezza, Krystexxa, and Uplizna, acquired from Horizon in October 2023, showed improvement in the second quarter and are expected to continue this trend [7] Biosimilar Market Impact - Lower revenues from oncology biosimilars and legacy products are anticipated, although newer biosimilars like Wezlana and Pavblu may contribute to sales growth [8][10] Financial Outlook - Higher R&D costs are likely to impact operating margins negatively in the third quarter [11] - Amgen's earnings surprise history shows a strong performance, with an average surprise of 11.75% over the last four quarters [12] Earnings Prediction - The current Earnings ESP for Amgen is -1.25%, indicating uncertainty regarding an earnings beat this quarter [14]

Core Insights - Dr. Reddy's Laboratories Limited (RDY) reported Q2 fiscal 2026 earnings of 19 cents per American Depositary Share (ADS), exceeding the Zacks Consensus Estimate of 18 cents, and up from 17 cents per ADS in the same quarter last year [1][5] - Revenues increased by 9.8% year over year to $992 million, surpassing the Zacks Consensus Estimate of $983 million, primarily driven by growth in global generics revenues [1][5] Revenue Breakdown - Global Generics revenues reached INR 78.5 billion, reflecting a 10% year-over-year increase, mainly due to the acquired Nicotine Replacement Therapy portfolio in Europe and strong performance in branded markets [2] - Pharmaceutical Services & Active Ingredients (PSAI) revenues amounted to INR 9.5 billion, up 12% year over year, driven by new active pharmaceutical ingredients (APIs) and favorable foreign exchange [7] - Revenues in the Others segment totaled INR 0.1 billion, down 42% year over year [7] Regional Performance - North America segment revenues declined by 13%, attributed to increased price erosion in key products like Lenalidomide, although this was partially offset by favorable foreign exchange and contributions from new product launches [3] Product Development and Approvals - As of September 30, 2025, Dr. Reddy's had 75 generic filings pending FDA approval, including 73 abbreviated new drug applications (ANDAs) and two new drug applications, with 45 of the ANDAs being Para IVs [4] - The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for AVT03, a proposed biosimilar to Amgen's Prolia and Xgeva, which is now under review by the European Commission [10][12] Financial Metrics - Gross margin decreased by 492 basis points to 54.7% due to higher price erosion in generics and reduced operating leverage [8] - Research and development (R&D) expenses were $70 million, down 15% year over year, as investments in biosimilars decreased following major funding completion for the Abatacept biosimilar candidate [8] - Selling, general and administrative expenses rose to $298 million, up 15% year over year, driven by increased sales and marketing investments [9] Strategic Moves - Dr. Reddy's announced an agreement to acquire the Stugeron portfolio from Johnson & Johnson, marking its entry into the anti-vertigo market, enhancing its central nervous system portfolio [16]

Core Viewpoint - Alvotech has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use recommending approval for its biosimilar AVT03, which is a proposed alternative to Prolia and Xgeva, pending final decision by the European Commission [1][4]. Company Overview - Alvotech is a global biotech company focused on developing and manufacturing biosimilar medicines, aiming to provide affordable biologic treatments to patients worldwide [7]. - The company has already approved and marketed two biosimilars, targeting Humira and Stelara, and has a pipeline of nine additional biosimilar candidates for various conditions [7]. Product Details - AVT03 is a human monoclonal antibody biosimilar candidate to Prolia (denosumab 60 mg/mL) and Xgeva (denosumab 70 mg/mL) [5]. - Prolia is used for treating osteoporosis and bone loss in specific patient populations, while Xgeva is indicated for preventing bone complications in advanced cancer patients [3]. Commercial Partnerships - Upon approval, Alvotech's commercial partners, STADA and Dr. Reddy's, will market AVT03 in Europe, with STADA using the tradenames Kefdensis and Zvogra, and Dr. Reddy's using Acvybra and Xbonzy [4][6].

Core Viewpoint - Alvotech has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use recommending approval for its biosimilar AVT03, which is a proposed alternative to Prolia® and Xgeva® [1][4] Company Overview - Alvotech is a global biotech company focused on developing and manufacturing biosimilar medicines, aiming to provide affordable biologic treatments to patients worldwide [7] - The company has already approved and marketed two biosimilars, with a pipeline that includes nine additional candidates targeting various diseases [7] Product Details - AVT03 is a human monoclonal antibody biosimilar candidate to Prolia® (denosumab 60 mg/mL) and Xgeva® (denosumab 70 mg/mL) [5] - Prolia® is indicated for treating osteoporosis and bone loss in specific patient populations, while Xgeva® is used to prevent bone complications in advanced cancer patients [3] Commercial Partnerships - Upon approval, AVT03 will be marketed by Alvotech's partners, STADA and Dr. Reddy's, each holding semi-exclusive commercial rights in Europe, including Switzerland and the UK [1][4] - STADA will market the biosimilar under the names Kefdensis® and Zvogra®, while Dr. Reddy's will use the names Acvybra® and Xbonzy® [4] Regulatory Status - AVT03 is currently under review by the EMA, with a final decision pending from the European Commission [4]