Latest news with #Novartis'
Yahoo
18-07-2025
- Business
- Yahoo
Novartis culls ianalumab in HS after Phase IIb trial failure
Novartis is stopping the development of ianalumab in hidradenitis suppurativa (HS) after a Phase IIb proof-of-concept trial failed to meet its primary endpoint. The study (NCT03827798) had enrolled 248 patients with HS and was evaluating the change in simplified Hidradenitis Suppurativa Clinical Response (sHiSCR) after 16 weeks. The termination of the therapy in HS was announced in Novartis' Q2 results, with the company stating: 'Novartis will not advance investigation of ianalumab in HS following a Phase II proof-of-concept study which did not meet our target criteria despite demonstrating efficacy vs placebo. No new safety signals were observed, and all other studies for ianalumab in B-cell driven diseases continue as planned.' The indications Novartis will continue the development of ianalumab for include lupus nephritis, Sjögren syndrome, and autoimmune hepatitis. Ianalumab is a monoclonal antibody directed against the BAFF (B cell-activating factor belonging to the TNF family) receptor. It acts by preventing the activation of B cells to avoid overproduction. By reducing the number and activity of B cells, ianalumab can help to dampen the harmful immune responses that drive autoimmune diseases. If approved, GlobalData predicts ianalumab to reach sales of $638m in 2031. GlobalData is the parent company of Clinical Trials Arena. Four other pipeline drugs in Phase IIb study The Phase IIb trial also evaluated the efficacy of four other drugs in Novartis' pipeline, namely iscalimab, remibrutinib, LYS-006 and MAS-825. Data from the remibrutinib was presented at the American Academy of Dermatology (AAD) meeting in March 2024, with the drug having met its primary endpoint. As a result, Novartis is now running a Phase III trial of the therapy in HS (NCT06799000). Novartis has already secured a drug in the HS treatment space, after Cosentyx (secukinumab) gained approval from the US Food and Drug Administration (FDA) in October 2023. UCB's Bimzelx (bimekizumab) is the most recent biologic in HS, having been approved by the FDA in November 2024. AbbVie's flagship Humira (adalimumab) is also approved in HS and was the first biologic to be approved in the indication in 2015. "Novartis culls ianalumab in HS after Phase IIb trial failure" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.
CNBC
17-07-2025
- Business
- CNBC
Novartis raises outlook on strong second-quarter sales
CNBC's Karen Gilchrist weighs in on Novartis' second-quarter earnings and efforts to diversify its drug portfolio beyond its blockbuster Entresto heart failure treatment.
CNBC
17-07-2025
- Business
- CNBC
Swiss pharma giant Novartis bets on a breast cancer blockbuster as sales rise
Swiss pharmaceutical firm Novartis said Thursday that it expects its Kisqali breast cancer treatment to be the next blockbuster drug within its portfolio, as it looks to shift reliance away from its Entresto heart failure therapy. Sales of Kisqali, which treats metastatic breast cancer, surged 64% globally on a constant currency basis in the three months to June, the company said in its second-quarter sales report. That includes 100% growth in the U.S. It follows a 56% increase in Kisqali sales in the first quarter to March. Speaking on an earnings call, CEO Vas Narasimhan said Kisqali was the drug with the greatest scope for outperformance. Global breast cancer diagnoses and deaths are projected to increase by 2050, according to the World Health Organization's cancer agency, with 1 in 20 women worldwide expected to be diagnosed with breast cancer in their lifetime. That could translate to 3.2 million new cases and 1.1 million deaths a year worldwide by 2050 if current trends continue, the study found — significantly higher than 2022's 2.3 million new cases and 670,000-related deaths. Narasimhan also cited Novartis' "strong pipeline" of other drugs, including its Pluvicto prostate cancer treatment and Scemblix for chronic myeloid leukemia, which he said was also "on track to be a blockbuster." "We continue to drive strong performance on our ongoing launches for Kisqali, Pluvicto, and Scemblix, demonstrating the replacement power in our portfolio," he added in a statement accompanying the results. The comments come as Novartis seeks to shake its reliance on its top-selling Entreso heart failure drug, which faces U.S. patent expiry next year. Entresto brought in $7.8 billion in 2024, accounting for around 15% of the company's overall global sales. It said Thursday that it expects generic drug makers to begin producing copycat versions of the drug by mid-2025, although that timeline is "subject to ongoing IP [intellectual property] and regulatory litigation." On Wednesday, a U.S. federal judge rejected Novartis' request for a preliminary injunction to stop MSN Pharmaceuticals from selling a generic version of the drug before the patent expires. Sales of Entresto rose 22% in the second quarter, in line with the prior three-month period. "Short-term it's an important product for us," outgoing chief financial officer Harry Kirsch said of Entresto Thursday. "We have IP that we're defending. Should we be successful in further defending our appeal, each month we'll have some nice significant upside," he added. Overall, Novartis' second-quarter net sales rose 11% on a constant currency basis to $14.05 billion, just shy of the $14.18 billion estimated by analysts in an LSEG poll. Quarterly adjusted core operating income, meanwhile, rose 21% to $5.93 billion, slightly above the $5.69 billion expected. Novartis said it now expects full-year core operating income to grow by "low teens," up from "low double-digit" previously, while it retained its forecast for sales growth in the high single digits. The company also announced an up to $10 billion share buyback, citing "confidence" in its mid- and long-term growth.
Yahoo
14-07-2025
- Business
- Yahoo
Novartis AG (VTX:NOVN) On An Uptrend: Could Fundamentals Be Driving The Stock?
Novartis' (VTX:NOVN) stock is up by 6.7% over the past three months. As most would know, long-term fundamentals have a strong correlation with market price movements, so we decided to look at the company's key financial indicators today to determine if they have any role to play in the recent price movement. Particularly, we will be paying attention to Novartis' ROE today. Return on Equity or ROE is a test of how effectively a company is growing its value and managing investors' money. In simpler terms, it measures the profitability of a company in relation to shareholder's equity. Trump has pledged to "unleash" American oil and gas and these 15 US stocks have developments that are poised to benefit. The formula for return on equity is: Return on Equity = Net Profit (from continuing operations) ÷ Shareholders' Equity So, based on the above formula, the ROE for Novartis is: 33% = US$13b ÷ US$38b (Based on the trailing twelve months to March 2025). The 'return' refers to a company's earnings over the last year. That means that for every CHF1 worth of shareholders' equity, the company generated CHF0.33 in profit. See our latest analysis for Novartis So far, we've learned that ROE is a measure of a company's profitability. We now need to evaluate how much profit the company reinvests or "retains" for future growth which then gives us an idea about the growth potential of the company. Assuming all else is equal, companies that have both a higher return on equity and higher profit retention are usually the ones that have a higher growth rate when compared to companies that don't have the same features. First thing first, we like that Novartis has an impressive ROE. Second, a comparison with the average ROE reported by the industry of 25% also doesn't go unnoticed by us. Despite this, Novartis' five year net income growth was quite flat over the past five years. So, there could be some other aspects that could potentially be preventing the company from growing. These include low earnings retention or poor allocation of capital We then compared Novartis' net income growth with the industry and found that the company's growth figure is lower than the average industry growth rate of 9.2% in the same 5-year period, which is a bit concerning. Earnings growth is an important metric to consider when valuing a stock. It's important for an investor to know whether the market has priced in the company's expected earnings growth (or decline). By doing so, they will have an idea if the stock is headed into clear blue waters or if swampy waters await. If you're wondering about Novartis''s valuation, check out this gauge of its price-to-earnings ratio, as compared to its industry. With a high three-year median payout ratio of 80% (implying that the company keeps only 20% of its income) of its business to reinvest into its business), most of Novartis' profits are being paid to shareholders, which explains the absence of growth in earnings. In addition, Novartis has been paying dividends over a period of at least ten years suggesting that keeping up dividend payments is way more important to the management even if it comes at the cost of business growth. Upon studying the latest analysts' consensus data, we found that the company's future payout ratio is expected to drop to 43% over the next three years. However, the company's ROE is not expected to change by much despite the lower expected payout ratio. In total, it does look like Novartis has some positive aspects to its business. Yet, the low earnings growth is a bit concerning, especially given that the company has a high rate of return. Investors could have benefitted from the high ROE, had the company been reinvesting more of its earnings. As discussed earlier, the company is retaining a small portion of its profits. Having said that, looking at the current analyst estimates, we found that the company's earnings are expected to gain momentum. To know more about the latest analysts predictions for the company, check out this visualization of analyst forecasts for the company. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.
Euronews
08-07-2025
- Health
- Euronews
Swiss regulator approves first malaria treatment for newborn babies
Switzerland's drug regulator has approved the world's first malaria treatment for newborn babies, clearing the way for the medicine to become available in parts of Africa where the life-threatening disease is endemic. In a late-stage clinical trial, pharmaceutical giant Novartis showed the drug was safe and effective for babies weighing less than five kilograms, which they typically reach by two months of age. Traditionally, these infants have been given either a full or half-dose of the antimalarial drug intended for babies six months or older. But because newborns do not process medicines the same way, there is a higher risk of side effects. The lack of specialised treatment – and the fact that babies are not vaccinated until they are around five months old – has left the youngest infants relatively unprotected against malaria, a mosquito-borne disease that kills about 597,000 people per year. Most deaths are among children under five years old in Africa. It's not clear exactly how many babies are affected, but in 2023, there were an estimated 36 million pregnancies in 33 African countries where malaria is widespread. About one in three mothers were infected with malaria while pregnant, raising the risk that they will pass the disease along to their newborns, according to the World Health Organization (WHO). 'Every one of those [babies] is a potential target for malaria infection,' Dr Lutz Hegemann, president of Novartis' global health programme, told Euronews Health. 'We don't want to leave any patient behind, no matter how small they are'. Eight African countries – Burkina Faso, Ivory Coast, Kenya, Malawi, Mozambique, Nigeria, Tanzania, and Uganda – are expected to quickly approve the medicine as part of a partnership with Swissmedic, the Swiss drugs regulator. Hegemann said Novartis hopes to roll the medicine out there this autumn, with more countries to follow, on a not-for-profit basis. The medicine, known as Coartem Baby, is similar to Novartis' existing drug to treat uncomplicated malaria in young children, but it has a different dose and ratio of ingredients to prevent side effects in the youngest infants. It also has a sweet cherry flavour and can be dissolved in breast milk to make it easier to give to patients. 'These are small changes, but big steps,' Dr Quique Bassat, head of the Barcelona Institute of Global Health, told Euronews Health. While the number of newborns with malaria 'still remains relatively modest in terms of the overall burden, those cases need to be treated, and therefore we need better drugs,' he added. 'Now we have something which is perfectly suitable for that specific age group where there was a gap'. Bassat advised Novartis on the clinical trial, which was funded by the European Union and the Swedish International Development Cooperation Agency.
