Latest news with #Kisqali
Yahoo
22-07-2025
- Business
- Yahoo
Kisqali Emerges as Novartis AG (NVS) Blockbuster with Record Q2 Growth
We recently published Novartis AG stands third among the most undervalued stocks. Novartis AG (NYSE:NVS) is a Swiss pharmaceutical leader focused on developing innovative treatments across oncology, immunology, neuroscience, cardiovascular, and renal diseases. The company continues to invest heavily in research and development, aiming to deliver breakthrough medicines that improve patient outcomes worldwide. The company's Kisqali (ribociclib) has emerged as a major growth driver, with Q2 2025 sales surging 64% globally and 100% in the U.S. It targets metastatic breast cancer and is positioned as a potential blockbuster. Other notable therapies include Pluvicto for prostate cancer and Scemblix for chronic myeloid leukemia, both showing strong commercial momentum. Novartis AG (NYSE:NVS) is expanding its presence in nephrology. Vanrafia (atrasentan) recently received FDA accelerated approval for reducing proteinuria in IgA nephropathy, marking a key advancement. Fabhalta (iptacopan), an oral treatment for C3 glomerulopathy, also gained approval. Ongoing trials include zigakibart, a Phase III candidate for IgAN, with results expected in 2026. The business introduced Coartem Baby, a pediatric malaria treatment approved by Swissmedic. It addresses the unmet need for infants under 5 kg with a cherry-flavored, easily dissolvable formulation. Novartis AG (NYSE:NVS) plans to launch it on a not-for-profit basis in malaria-endemic regions. A pharmacy technician in a laboratory preparing medication for retail distribution. The corporation has streamlined its pipeline around core therapeutic areas, with several Phase III trials in progress. These include remibrutinib for autoimmune diseases, ianalumab for lupus, and YTB323 for neuroimmunological disorders. The company expects 15 submission-enabling data readouts over the next two years, which underscores a robust late-stage pipeline. While we acknowledge the potential of NVS as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: 30 Stocks That Should Double in 3 Years and 11 Hidden AI Stocks to Buy Right Now. Disclosure: None. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
22-07-2025
- Business
- Yahoo
Kisqali Emerges as Novartis AG (NVS) Blockbuster with Record Q2 Growth
We recently published Novartis AG stands third among the most undervalued stocks. Novartis AG (NYSE:NVS) is a Swiss pharmaceutical leader focused on developing innovative treatments across oncology, immunology, neuroscience, cardiovascular, and renal diseases. The company continues to invest heavily in research and development, aiming to deliver breakthrough medicines that improve patient outcomes worldwide. The company's Kisqali (ribociclib) has emerged as a major growth driver, with Q2 2025 sales surging 64% globally and 100% in the U.S. It targets metastatic breast cancer and is positioned as a potential blockbuster. Other notable therapies include Pluvicto for prostate cancer and Scemblix for chronic myeloid leukemia, both showing strong commercial momentum. Novartis AG (NYSE:NVS) is expanding its presence in nephrology. Vanrafia (atrasentan) recently received FDA accelerated approval for reducing proteinuria in IgA nephropathy, marking a key advancement. Fabhalta (iptacopan), an oral treatment for C3 glomerulopathy, also gained approval. Ongoing trials include zigakibart, a Phase III candidate for IgAN, with results expected in 2026. The business introduced Coartem Baby, a pediatric malaria treatment approved by Swissmedic. It addresses the unmet need for infants under 5 kg with a cherry-flavored, easily dissolvable formulation. Novartis AG (NYSE:NVS) plans to launch it on a not-for-profit basis in malaria-endemic regions. A pharmacy technician in a laboratory preparing medication for retail distribution. The corporation has streamlined its pipeline around core therapeutic areas, with several Phase III trials in progress. These include remibrutinib for autoimmune diseases, ianalumab for lupus, and YTB323 for neuroimmunological disorders. The company expects 15 submission-enabling data readouts over the next two years, which underscores a robust late-stage pipeline. While we acknowledge the potential of NVS as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: 30 Stocks That Should Double in 3 Years and 11 Hidden AI Stocks to Buy Right Now. Disclosure: None.
Medscape
18-07-2025
- Health
- Medscape
NICE Widens Access to Ribociclib for Early Breast Cancer
The National Institute for Health and Care Excellence (NICE) has recommended ribociclib (Kisqali, Novartis) for routine NHS use in adjuvant treatment of hormone receptor-positive, HER2-negative early breast cancer in patients at high risk of recurrence. The drug is now recommended for use alongside an aromatase inhibitor after initial treatments, such as surgery. In pre-menopausal women, the aromatase inhibitor should be combined with a luteinising hormone-releasing hormone agonist. Targeted Therapy for Common Breast Cancer Subtype Ribociclib is a cyclin-dependent kinase (CDK) 4/6 inhibitor. It works by blocking proteins that drive cancer cell growth and division. NICE said the treatment 'represents a significant advance' in managing hormone receptor-positive, HER2-negative early breast cancer. Breast cancer is the most common cancer in the UK. Hormone receptor-positive, HER2-negative breast cancer is the most common subtype, accounting for about 68% of all UK cases. Expanded NHS Use Follows Evidence Submission Until now, NHS access in England was limited to patients whose cancer had spread to nearby lymph nodes. NICE approved this use of ribociclib in April 2025 but asked Novartis for more evidence to justify broader access. Following further review, NICE concluded in final draft guidance that ribociclib with an aromatase inhibitor offers clinical benefit and value for money. It is now considered a cost-effective use of NHS resources. Trial Shows Delayed Recurrence A clinical trial involving more than 5000 patients showed that ribociclib combined with an aromatase inhibitor delayed disease recurrence compared with the aromatase inhibitor alone. The latest analysis, based on a mean of 33 months' follow-up, continued to show improved invasive disease-free survival across key subgroups. However, NICE said that it remained unclear whether the combination increased overall survival and that more mature data, including predictions of longer-term outcomes, is needed. Further data from the trial are expected in May 2026. Comparable to Other Options Indirect evidence suggests that ribociclib plus an aromatase inhibitor is as effective as abemaciclib plus endocrine therapy. Abemaciclib is currently used for node-positive breast cancer. Ribociclib in combination with fulvestrant is already recommended for treating hormone receptor-positive, HER2-negative, locally advanced or metastatic breast cancer in adults who have had previous endocrine therapy. This demonstrated 'the drug's versatility across different stages of the disease,', NICE said. Helen Knight, director of medicines evaluation at NICE, described the latest decision as 'fantastic news for the tens of thousands of patients and their loved ones'. An estimated 5700 people with early breast cancer could benefit from expanded access to the combination treatment. Relapse after initial treatment occurs in about 30% of people with early breast cancer. Patient experts told the NICE committee that the high risk of recurrence has a considerable impact on quality of life. 'The fear of the cancer returning is a common cause of stress and anxiety for people and their families, affecting physical and psychological wellbeing,' they said. Treatment options are limited and have unpleasant side effects. Having different options is particularly important because people often choose treatments based on their side-effect profiles. Both patient and clinical experts emphasised the importance of treatment choice. Dosage, Side Effects, and Pricing Ribociclib is taken orally, which may improve convenience and adherence compared with alternatives. The usual dose of ribociclib is: 400 mg once daily (two 200 mg tablets) for primary breast cancer 600 mg once daily (three 200 mg tablets) for locally advanced or secondary disease Common side effects include leukopaenia and increased infection risks, anaemia, anorexia, nausea and vomiting, diarrhoea and constipation, abdominal pain, fatigue, sore mouth, shortness of breath, cough, rashes, and hair loss. The list prices of ribociclib 200-mg tablets are: £983.33 for 21 tablets £1966.67 for 42 tablets £2950.00 for 63 tablets A simple patient access scheme allows the NHS to purchase the drug at a confidential discount. Knight said the expanded access was 'also due in no small part to the willingness of companies to engage with us constructively, as in the case with ribociclib, to ensure the benefits of their treatments are properly presented and appropriately priced'.
Yahoo
18-07-2025
- Business
- Yahoo
Novartis AG (NVS) Q2 2025 Earnings Call Highlights: Strong Growth and Strategic Initiatives ...
Sales Growth: Up 11% in constant currency for Q2 2025. Core Operating Income: Increased by 21% in constant currency. Core Margin: Improved by 340 basis points to 42.2%. Core EPS: $2.42, up 24%. Free Cash Flow: $6.3 billion, up 37% in US dollars. Priority Brands Growth: Up 30% in constant currencies; excluding Entresto, up 33%. Kisqali Growth: 64% increase in Q2, with 100% growth in the US. Kesimpta Growth: 33% increase in Q2, with 28% growth in the US. Pluvicto Growth: 30% increase in Q2, with 40% growth in new patient starts. Leqvio Growth: 61% increase in Q2, with 47% growth in the US. Scemblix Growth: 79% increase in constant currency. Cosentyx Growth: 6% increase in Q2. Entresto Sales: $1.2 billion in Q2 2025. Full Year Guidance: High single-digit sales growth; core operating income to grow in the low teens. New Share Buyback Program: Up to $10 billion targeted for completion by the end of 2027. Warning! GuruFocus has detected 4 Warning Sign with MMC. Release Date: July 17, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Positive Points Novartis AG (NYSE:NVS) reported double-digit sales growth of 11% in constant currency for Q2 2025. Core operating income increased by 21% in constant currency, reflecting strong financial performance. The company upgraded its full-year 2025 bottom line guidance, indicating confidence in continued growth. Key brands like Kisqali, Kesimpta, and Pluvicto showed robust growth, with Kisqali achieving 64% growth in the quarter. A new $10 billion share buyback program was announced, demonstrating strong cash flow and commitment to returning capital to shareholders. Negative Points Cosentyx growth moderated to 6% in Q2, with challenges from new competitor entries and geographic-specific headwinds. The company faces potential impacts from US generic entry for Entresto, which could affect future sales. There is a slowdown in pharmaceutical spending in China, impacting growth for certain products like Cosentyx and Entresto. The competitive environment in the US remains challenging, particularly with Medicare Part D redesign affecting rebates. Uncertainties remain regarding the resolution of US drug pricing reforms, which could impact future pricing strategies. Q & A Highlights Q: Can you update on your level of confidence in the Phase II data for Sjogren's disease and clarify whether both studies need to be positive for a filing process? A: We are excited about the opportunity in Sjogren's disease, but acknowledge the challenges as no drug has shown significant benefit on the SIs. We have strong Phase II data and believe in the mechanism, but it's a tough indication. Whether both studies need to be positive depends on the data. We've had robust discussions with the FDA on primary and secondary endpoints, and based on the data, we'll determine the best path forward. We plan to inform the market based on the results of both studies simultaneously. - Vasant Narasimhan, CEO Q: How significant is the impact of healthcare spending tightening in China on Cosentyx, and how are you adapting your strategy to maintain growth? A: We've seen a notable slowdown in China, with our business growth coming down from over 20% last year. We expect China to grow in the high single-digit to low-teens range, which is factored into our guidance. The slowdown impacts medicines on the NRDL listing, like Cosentyx and Entresto. However, the out-of-pocket market for Leqvio has been strong, and we are considering whether to move it into the NRDL listing. - Vasant Narasimhan, CEO Q: What is the latest you've heard from CMS, HHS, or your people on the hill about the administration's plans for drug pricing in the US? A: Conversations with the administration have been productive, focusing on having OECD markets pay more for innovative medicines and reducing US patient costs by cutting out intermediaries. We're moving forward with proposals, and HHS is evaluating them. The administration aims to maintain US leadership in biopharmaceutical innovation, balancing innovation rewards with patient affordability. - Vasant Narasimhan, CEO Q: Can you elaborate on the price/volume dynamics for Cosentyx and why you see the competitive environment as a temporary factor? A: The Medicare Part D redesign has impacted Cosentyx, increasing rebates. The competitive entry has caused an initial impact, but we expect the market to settle. We have strong frontline access across indications, and we're educating on dosing options to moderate switches. We see opportunities in the first switch off anti-TNFs and expect HS to be a $3 billion-plus market, with Cosentyx delivering $1 billion in sales. - Vasant Narasimhan, CEO & Harry Kirsch, CFO Q: How are you thinking about using Pluvicto in earlier lines, and are there concerns about its impact on continence and sexual function? A: We haven't heard concerns about continence and sexual function with Pluvicto. Its safety profile is compelling, with primary topics being salivary glands and bone marrow. We expect significant use in HSPC, with compelling RPFS data and maturing OS data. Ex-US, the topic is comparator choice, and we're confident in Pluvicto's peak sales guidance. Actinium PSMA is planned for post-Pluvicto settings, with potential earlier use depending on safety profile. - Vasant Narasimhan, CEO For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
17-07-2025
- Business
- Yahoo
Novartis Trims Operating Income Outlook After Strong Q2 Performance, Initiates $10 Billion Stock Buyback
Swiss pharmaceutical giant Novartis AG (NYSE:NVS) reported second-quarter 2025 earnings on Thursday and raised its full-year earnings forecast. Quarterly sales reached $14.05 billion, almost in line with the analysts' consensus estimate of $14.06 billion. Net sales grew 12% year over year (+11% on constant currency or cc) with core operating income up 20% to $5.93 billion (+21% on constant currency).Sales growth driven by performance from breast cancer treatment, Kisqali ($1.18 billion, +64% cc), Entresto ($2.36 billion, +22% cc), multiple sclerosis drug, Kesimpta ($1.08 billion, +33% cc), Scemblix ($298 million, +79% cc), Leqvio ($298 million, +61% cc), and Pluvicto ($454 million, +30% cc). Novartis reported adjusted earnings of $2.42 per share, beating the consensus of $2.38. The company also announced a substantial share buyback program. Novartis said it is initiating a share buyback of up $10 billion to be completed by year-end 2027. View more earnings on NVS 'Our robust balance sheet and confidence in our mid- and long-term growth enable us to initiate an up-to $10 billion share buyback as part of our commitment to balanced capital allocation,' stated CEO Vas Narasimhan in a statement on Thursday. Earlier in July, Novartis released topline results from the Phase 3 GCAptAIN study evaluating Cosentyx (secukinumab) for newly diagnosed or relapsing giant cell arteritis (GCA). The study evaluated Cosentyx with a 26-week steroid taper and compared it to a placebo plus a 52-week steroid taper. Cosentyx did not demonstrate a statistically significant improvement in sustained remission at Week 52 compared to placebo. Outlook For fiscal year 2025, Novartis reaffirms that net sales will grow in the high single digits. 2025 core operating income is expected to grow in the low teens, compared to the low double digits forecasted earlier. 'We continue to assume Entresto US generic entry in mid-2025 for forecasting purposes, though the timing of generic entry is subject to ongoing IP and regulatory litigation,' Novartis said in the release. Management Update In a separate announcement, Novartis provided a key leadership update: Chief Financial Officer Harry Kirsch will retire in March 2026, concluding an impressive 22-year tenure at the company, including 12 years in the CFO role since 2013. He will be succeeded by Mukul Mehta, who currently serves as the company's head of business planning and analysis, digital finance, and tax. Price Action: NVS stock is trading lower by 1.71% to $116.35 during the premarket session at last check Thursday. Read Next:Photo via Shutterstock UNLOCKED: 5 NEW TRADES EVERY WEEK. Click now to get top trade ideas daily, plus unlimited access to cutting-edge tools and strategies to gain an edge in the markets. Get the latest stock analysis from Benzinga? NOVARTIS (NVS): Free Stock Analysis Report This article Novartis Trims Operating Income Outlook After Strong Q2 Performance, Initiates $10 Billion Stock Buyback originally appeared on © 2025 Benzinga does not provide investment advice. All rights reserved. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
