Core Viewpoint - Analysts project Novartis (NVS) will report quarterly earnings of $2.26 per share, reflecting a 9.7% year-over-year increase, with revenues expected to reach $13.9 billion, an 8.4% increase from the same quarter last year [1]. Earnings Estimates - The consensus EPS estimate has remained unchanged over the last 30 days, indicating a collective reevaluation by analysts [1][2]. - Changes in earnings estimates are crucial for predicting investor reactions, as empirical research shows a strong correlation between earnings estimate revisions and short-term stock performance [2]. Revenue Projections - Analysts expect 'Revenues- Oncology- Tafinlar + Mekinist- Total' to be $555.75 million, a 4.1% increase year-over-year [4]. - 'Revenues- Net sales to third parties' are projected to reach $14.07 billion, indicating a 9.8% year-over-year change [4]. - 'Revenues- Oncology- Kisqali- Total' is estimated at $1.29 billion, reflecting a significant 64.2% year-over-year increase [4]. Specific Revenue Metrics - 'Revenues- Immunology- Cosentyx- Total' is expected to reach $1.72 billion, a 1.9% increase from the prior year [5]. - 'Revenues- Oncology- Tasigna- US' is projected at $119.43 million, showing a decline of 47.2% year-over-year [5]. - 'Revenues- Oncology- Promacta/Revolade- US' is estimated at $180.08 million, indicating a 41.2% decrease from the year-ago quarter [5]. Additional Revenue Insights - 'Revenues- Immunology- Cosentyx- US' is expected to be $990.42 million, a slight decrease of 0.3% year-over-year [6]. - 'Revenues- Cardiovascular- Entresto- US' is projected at $927.94 million, reflecting a 1.8% increase from the previous year [6]. - 'Revenues- Oncology- Tasigna- ROW' is estimated at $149.03 million, indicating a 22.8% decline year-over-year [7]. - 'Revenues- Oncology- Tafinlar + Mekinist- ROW' is expected to reach $320.55 million, a 4.4% increase year-over-year [7]. - 'Revenues- Oncology- Promacta/Revolade- ROW' is projected at $267.72 million, reflecting a 1.8% increase [7]. - 'Revenues- Immunology- Cosentyx- ROW' is expected to be $734.58 million, indicating a 4.9% increase from the prior year [8]. Stock Performance - Novartis shares have increased by 6.9% over the past month, outperforming the Zacks S&P 500 composite, which saw a 0.2% increase [8].

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Core Insights - Novartis announced that Cosentyx® (secukinumab) achieved significant results in the Phase III REPLENISH trial for treating polymyalgia rheumatica (PMR), meeting both primary and secondary endpoints [1][7] - The trial demonstrated that Cosentyx provided sustained remission compared to placebo at Week 52, indicating its potential as a novel treatment option for PMR [1][7] Company Overview - Novartis is an innovative medicines company focused on improving and extending patients' lives through advanced therapies, reaching nearly 300 million people globally [9] Product Information - Cosentyx is a fully human biologic that inhibits interleukin-17A, a key cytokine in various immune-mediated inflammatory diseases, and is already approved for multiple conditions including psoriatic arthritis and ankylosing spondylitis [4] - Since its launch in 2015, Cosentyx has treated over 1.8 million patients worldwide and is approved in more than 100 countries [4] Clinical Trial Details - The REPLENISH trial was a global Phase III, multicenter, randomized, double-blind, placebo-controlled study conducted in 27 countries, assessing the efficacy and safety of Cosentyx in PMR patients [3] - The primary endpoint was to determine if secukinumab 300mg plus a steroid taper was superior to placebo plus a steroid taper in achieving sustained remission at Week 52 [3] Disease Context - Polymyalgia rheumatica is the second most common inflammatory rheumatic disease in adults aged 50 and older, characterized by significant pain and stiffness, which can severely impact quality of life [5] - Long-term steroid use, the standard treatment, poses risks such as osteoporosis and diabetes, highlighting the need for effective alternatives like Cosentyx [5]

Core Points - Novartis announced the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act in relation to its tender offer to acquire Tourmaline Bio at a price of $48.00 per share in cash [1][2] - The expiration of the HSR Act waiting period is a necessary condition for the completion of the merger agreement dated September 8, 2025, which includes the tender offer and subsequent merger [2] - The tender offer will expire at 11:59 p.m. Eastern Time on October 27, 2025, unless extended or terminated earlier [2] Company Information - Novartis is an innovative medicines company focused on improving and extending people's lives through its products, reaching over 300 million people globally [7]

Group 1 - Chronic diseases account for 88.5% of total deaths in China, with cardiovascular diseases, cancer, and diabetes being the primary burdens [1] - The total number of cardiovascular disease patients in China is approximately 330 million, creating significant economic pressure on families and the healthcare system [1] - Novartis has proposed a digital blueprint for lipid management and cardiovascular prevention in Shanghai, aiming to establish an AI-driven health management system for city residents [1] Group 2 - The management of chronic diseases requires multi-departmental collaboration and public participation, as emphasized by Wu Jing, Director of the Chronic Disease Center at the Chinese CDC [2] - AstraZeneca has supported over ten basic research projects in the fields of oncology, chronic diseases, and rare diseases through its China Translational Medicine Research Fund [2] - AstraZeneca has initiated a "China Postdoctoral Program" to support future scientific leaders and enhance local research innovation capabilities in chronic and rare diseases [2] Group 3 - China has accumulated rich resources and experience in respiratory diseases and possesses internationally recognized disease cohorts and biobanks, which can support global target discovery and translational research [3]

Core Insights - Swiss drugmaker Novartis announced that its targeted radiotherapy treatment Pluvicto has demonstrated a 28% reduction in the risk of progression or death in patients with prostate cancer [1] Company Summary - Novartis is focusing on innovative treatments for cancer, with Pluvicto being a significant advancement in targeted radiotherapy [1] Industry Summary - The announcement highlights the ongoing advancements in cancer treatment, particularly in targeted therapies, which are becoming increasingly important in improving patient outcomes [1]

Core Insights - Novartis presented new data on Pluvicto™ at the ESMO Congress 2025, highlighting its efficacy in treating metastatic hormone-sensitive prostate cancer [1][5] Efficacy of Pluvicto - Pluvicto combined with standard of care (SoC) showed a 28% reduction in the risk of radiographic progression or death compared to SoC alone in patients with PSMA+ metastatic hormone-sensitive prostate cancer (mHSPC) [2][7] - An early positive trend in overall survival was observed with a hazard ratio (HR) of 0.84, indicating potential benefits in long-term outcomes [3][7] - The overall response rate (ORR) was higher in the Pluvicto plus SoC group (85.3%) compared to SoC alone (80.8%) [3][7] Safety Profile - The safety profile of Pluvicto was consistent with previous studies, with grade ≥3 adverse events reported in 50.7% of patients receiving Pluvicto plus SoC, compared to 43% in the SoC group [4][7] - Common adverse events included dry mouth, fatigue, nausea, hot flush, and anemia [4] Regulatory and Market Implications - PSMAddition marks the third positive Phase III trial for Pluvicto, reinforcing its potential to improve outcomes in earlier stages of metastatic prostate cancer [5][7] - Novartis plans to submit these findings to regulatory authorities by the end of the year, which could double the number of patients eligible for Pluvicto [7] Unmet Need in mHSPC - Approximately 172,000 men are diagnosed with mHSPC annually in major markets, with most progressing to metastatic castration-resistant prostate cancer (mCRPC) within 20 months [6] - The progression to mCRPC is associated with significantly worse outcomes, highlighting the urgent need for effective therapies [6][7] About Pluvicto - Pluvicto is a radioligand therapy that targets PSMA-expressing cells, delivering treatment directly to cancer cells [9][10] - It is the only PSMA-targeted agent approved for PSMA+ mCRPC and has shown clinical benefits in mHSPC [10] Novartis and RLT - Novartis is advancing cancer care through radioligand therapy (RLT), focusing on targeted radiation to treat advanced cancers [11] - The company is expanding its RLT manufacturing capabilities to meet growing demand [11]

Core Insights - Novartis presented new data on Pluvicto™ from the Phase III PSMAddition trial, showing significant improvements in treatment outcomes for patients with metastatic hormone-sensitive prostate cancer [1][5]. Efficacy of Pluvicto - Pluvicto combined with standard of care (SoC) reduced the risk of radiographic progression or death by 28% (HR 0.72; 95% CI: 0.58, 0.90) compared to SoC alone in patients with PSMA+ metastatic hormone-sensitive prostate cancer [2][6]. - An early positive trend in overall survival (OS) was observed with a hazard ratio of 0.84 (95% CI: 0.63, 1.13) for patients treated with Pluvicto plus SoC [3][6]. - The complete response rate was higher in the Pluvicto plus SoC group (57.1%) compared to SoC alone (42.3%), and the overall response rate was also numerically higher (85.3% vs. 80.8%) [3][6]. - Pluvicto delayed progression to metastatic castration-resistant prostate cancer (mCRPC) with a hazard ratio of 0.70 (95% CI: 0.58, 0.84) [3][6]. Safety Profile - The safety profile of Pluvicto was consistent with previous studies, with grade ≥3 adverse events reported in 50.7% of patients in the Pluvicto plus SoC arm compared to 43% in the SoC alone group [4][6]. - Common adverse events included dry mouth, fatigue, nausea, hot flush, and anemia [4][6]. Regulatory and Market Implications - PSMAddition is the third positive Phase III trial for Pluvicto, building on previous successes that led to FDA approval for mCRPC in March 2025 [5][6]. - Novartis plans to submit the new data to regulatory authorities by the end of the year, which could potentially double the number of patients eligible for Pluvicto [5][6]. Unmet Medical Need - Approximately 172,000 men are diagnosed with metastatic hormone-sensitive prostate cancer annually in major markets, highlighting the urgent need for effective therapies [6][7]. - Most patients with this condition progress to mCRPC, which is associated with significantly worse outcomes and a life expectancy of less than two years [7][6]. About Pluvicto - Pluvicto is a radioligand therapy that targets PSMA-expressing cells, delivering treatment directly to prostate cancer cells [9][10]. - It is the only PSMA-targeted agent approved for PSMA+ mCRPC and the first to show clinical benefit in mHSPC in a Phase III trial [10]. Novartis and Radioligand Therapy - Novartis is advancing cancer care through radioligand therapy, focusing on targeted radiation to treat advanced cancers [11]. - The company is expanding its RLT manufacturing capabilities to meet growing demand and is exploring new isotopes and combination therapies for various cancers [11].

Core Insights - Novartis announced positive results from the five-year analysis of the Phase III NATALEE trial for Kisqali (ribociclib), showing a sustained benefit in reducing the risk of recurrence in high-risk early breast cancer patients [1][2][4] Efficacy Results - The trial demonstrated a 28.4% reduction in the risk of recurrence (HR=0.716; 95% CI 0.618-0.829; nominal p-value <0.0001) for patients treated with Kisqali plus endocrine therapy (ET) compared to ET alone [1] - Five-year invasive disease-free survival (iDFS) rates were 85.5% for the Kisqali plus ET group versus 81.0% for the ET alone group, indicating a 4.5% improvement [2] - A 29.1% risk reduction in distant disease-free survival was also observed [6] Long-term Benefits - The benefits of Kisqali persist beyond the three-year treatment period, providing patients with a greater chance of remaining breast cancer-free [3][4] - Overall survival (OS) showed a trend towards improvement, with a hazard ratio of 0.800, indicating a 20% reduction in the risk of death compared to ET alone [4] Subgroup Analysis - iDFS results across pre-specified subgroups showed consistent benefits: - Stage II: HR 0.660 (3.7% absolute risk reduction) - Stage III: HR 0.730 (5.6% absolute risk reduction) - Node-negative: HR 0.606 (5.7% absolute risk reduction) - Node-positive: HR 0.737 (4.4% absolute risk reduction) [5] Safety Profile - Long-term safety data indicated no new safety signals, with secondary primary malignancies reported at 2.7% for Kisqali plus ET and 3.0% for ET alone [7] Regulatory Status - Kisqali is approved in over 100 countries, including the U.S. and EU, for various indications in HR+/HER2- early and advanced breast cancer [10][11] Clinical Guidelines - Kisqali is recommended as a Category 1 preferred treatment in the NCCN Guidelines for both node-positive and high-risk node-negative early breast cancer [11][12]

Core Insights - Novartis received a positive opinion from the CHMP of the EMA for Scemblix (asciminib) to treat adult patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase across all treatment lines [1][4] Group 1: Treatment Efficacy - Scemblix showed superior major molecular response (MMR) rates compared to all tyrosine kinase inhibitors (TKIs) in the Phase III ASC4FIRST trial, achieving 67.7% MMR at week 48 versus 49.0% for investigator-selected TKIs [2][5] - At week 96, Scemblix maintained superior MMR rates of 74.1% compared to 52% for investigator-selected TKIs [7] - The treatment demonstrated fewer dose reductions and half the rate of adverse events leading to discontinuation compared to existing therapies [2][4] Group 2: Patient Impact - The availability of Scemblix is expected to provide patients with better treatment options, improving their chances of achieving key efficacy milestones while maintaining quality of life [2][3] - Approximately 50% of newly diagnosed CML patients miss treatment goals within one year, highlighting the need for more effective and tolerable treatment options [6] Group 3: Regulatory and Market Position - Scemblix is already approved in over 20 countries, including the US, Japan, and China, and is recommended by the 2025 European LeukemiaNet guidelines for newly diagnosed Ph+ CML-CP patients [3][9] - If approved by the European Commission, Scemblix will expand access to treatment for four times as many patients in Europe [6]