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Novartis' Cholesterol Drug Meets Primary Goals in Late-Stage Study
ZACKS· 2024-08-29 14:51
Novartis (NVS) announced positive data on the cholesterol drug Leqvio (inclisiran) from the late-stage VMONO study. Leqvio is the first and only small interfering RNA (siRNA) therapy to lower low-density lipoprotein cholesterol (LDL-C). The drug is administered as a subcutaneous injection with an initial dose, another at three months, and then every six months. The drug is approved in several countries, including the United States, EU, Japan and China. Shares of Novartis have risen 18.8% year to date compar ...
Novartis twice-yearly* Leqvio® demonstrated clinically meaningful, statistically significant LDL-C lowering as a monotherapy in patients at low or moderate ASCVD risk
GlobeNewswire News Room· 2024-08-28 05:15
Phase III V-MONO study met its primary endpoints, demonstrating superiority of Leqvio (inclisiran) monotherapy vs both placebo and ezetimibe in LDL-C reduction1 Results add to growing body of evidence for Leqvio across the ASCVD continuum Data will be shared with regulatory agencies and presented at an upcoming medical meeting V-MONO is part of the 60,000-patient VictORION clinical trial program assessing Leqvio for primary and secondary ASCVD prevention Basel, August 28, 2024 – Novartis announced today pos ...
Novartis' (NVS) Motion to Block Entresto Generic Denied: What's Next?
ZACKS· 2024-08-15 15:20
Novartis (NVS) recently suffered another setback in its attempt to block the entry of a generic version of its blockbuster heart drug Entresto. On Aug 12, judge Richard Andrews of The United States District Court For The District Of DelaWare denied Novartis' motion for preliminary injunction against MSN Pharmaceuticals Inc., MSN Laboratories Private Limited and MSN Life Sciences Private Limited for the launch of a generic version of Entresto. Several generic manufacturers are looking to launch a generic ver ...
Novartis receives FDA accelerated approval for Fabhalta® (iptacopan), the first and only complement inhibitor for the reduction of proteinuria in primary IgA nephropathy (IgAN)
Prnewswire· 2024-08-07 23:38
Fabhalta achieved a 44% proteinuria reduction from baseline in Phase III APPLAUSE-IgAN interim analysis, compared with 9% in placebo arm, demonstrating a clinically meaningful reduction of 38% vs. placebo (p<0.0001)1 Fabhalta is an inhibitor of the alternative complement pathway, activation of which is thought to contribute to the pathogenesis of IgAN1-4 Despite current standard of care, up to 50% of IgAN patients with persistent proteinuria progress to kidney failure within 10 to 20 years of diagnosis5-11 ...
Exploring New Frontiers in Food Allergy Treatments: Market Set for $14B Growth
Prnewswire· 2024-07-29 20:53
VANCOUVER, BC, July 29, 2024 /PRNewswire/ -- USA News Group – How and what we eat is always changing. But for more and more people, the options to eat are drastically being reduced, due to rising amounts of food allergies. According to Food Allergy Research & Education (FARE), food allergy prevalence among children has been surging, up by 50% between 1997 and 2011, and up again by another 50% between 2007 and 2021. Research analysts at Spherical Insights projects strong growth in the Global Allergy Treatmen ...
Novartis: Another Beat, Another Raise
Seeking Alpha· 2024-07-20 07:50
Core Viewpoint - Following the Sandoz spin-off, Novartis is now focused solely on innovative medicines, leading to a significant increase in margins and a stock price rise of 14.96% since the upgrade to a buy rating in April 2024 [1][17]. Financial Performance - In Q2 2024, Novartis reported net revenues of $12.51 billion, an 11% increase year-over-year, with a 9% increase at constant rates, driven by products like Entresto, Kesimpta, Cosentyx, and Kisqali [2][3]. - The EBIT margin rose by 270 basis points to 39.6%, attributed to operating leverage from higher sales [2]. - For the first half of 2024, sales increased to $24.34 billion from $22.24 billion in H1 2023, with an operating income margin improvement of nearly 600 basis points [3]. Dividend and Shareholder Returns - Novartis increased its dividend per share, with total payouts reaching $8.6 billion, making it one of the largest dividend payers globally [1]. - The company has an ongoing buyback plan of up to $15 billion, with approximately $10.1 billion remaining to be executed [12]. Guidance and Future Outlook - Novartis has raised its guidance for core operating income growth to the mid-to-high teens, reflecting strong momentum in key growth drivers [6]. - The company expects no change in net sales but anticipates improved margins, with core operating income projected to grow from low double-digit performance [6]. Product Pipeline and Growth Drivers - Key growth drivers include the acceleration of Cosentyx in the US, with a projected peak sales of $7 billion by 2029, and supportive momentum from Leqvio and Pluvicto [7]. - The pipeline includes promising products like Kisqali and Kesimpta, both with expected peak sales of $4 billion, expiring by 2030-2031 [12]. Market Position and Valuation - Novartis reported sales and EPS that exceeded consensus estimates by 2% and 5%, respectively, indicating a potential stock price upgrade [12]. - The company's core operating margin reached 40.4%, surpassing the consensus of 38.4%, with new guidance approximately 3% higher than current consensus [12][14].
Pharma Leader Beats on Earnings, But Shares Fall
MarketBeat· 2024-07-19 12:55
NVS -4.59 (-4.11%) $112.48 Price Target $118.13 Get XLV alerts: In 2023, 70% of revenue came from promoted brands, and 30% from established brands. Within promoted brands, the company divided revenue into four broad therapeutic areas: Cardiovascular, renal & metabolic, Immunology, Neuroscience, and Oncology. A notable strategic move by Novartis in 2023 was the spin-off of Sandoz. Sandoz is a producer of generics and biosimilars. This spin-off enables Novartis to focus on being what it calls a "pure-play inn ...
Why Novartis Stock Is Down Today Despite Topping Q2 Estimates
The Motley Fool· 2024-07-18 18:15
Investors were caught off guard by a decision on the research and development front. And yet, Novartis stock is down 4.5% as of 1:55 p.m. ET Thursday, according to data from S&P Global Market Intelligence. One red flag spoils an otherwise solid quarter Novartis is looking for more of the same in the near future. Its previous full-year projection for operating income growth in the low to mid teens was raised to an expectation of growth in the mid to high teens. That's a considerable increase for a company of ...
Novartis(NVS) - 2024 Q2 - Earnings Call Transcript
2024-07-18 16:49
Operator Thank you. Your next question comes from the line of Mark Purcell from Morgan Stanley. Mark Purcell Yes, thank you very much for taking my question. Vas, your revenue aspiration is for mid-single-digit growth out to 2030, and now on a 2024 basis with about $66 billion. And when we look at consensus, it's about $53 billion at the moment before the results that were very strong today, so about a $13 billion gap. So which growth drivers, in your opinion, does consensus underappreciate? And what are th ...
Novartis Falls Despite Earnings Beat, Guidance Raise
Investopedia· 2024-07-18 14:51
Novartis ADRs slid 3.5% to $107.83 as of 10:13 a.m. ET Thursday. They are up about 7% this year. Do you have a news tip for Investopedia reporters? Please email us at tips@investopedia.com Key Takeaways Novartis posted second-quarter net sales and adjusted profit that beat analysts' expectations. The drugmaker upped its full-year core operating income outlook for the second time in as many quarters. Novartis now expects fiscal 2024 core operating income to grow by a mid- to high-teen-percentage rate, up fro ...