Latest news with #Datroway
Reuters
18 hours ago
- Business
- Reuters
US approves AstraZeneca, Daiichi's treatment for lung cancer
June 24 (Reuters) - AstraZeneca (AZN.L), opens new tab said on Tuesday that U.S. regulators have approved its precision drug Datroway to treat a type of lung cancer, adding that the drugmaker would now pay partner Daiichi Sankyo (4568.T), opens new tab $45 million in milestone-related considerations.
Yahoo
21-05-2025
- Business
- Yahoo
AstraZeneca Stock Declines 6% in 3 Months: Time to Buy the Dip?
AstraZeneca AZN stock has declined 6.4% in the past three months. Although AstraZeneca faces its share of challenges, a significant portion of this price decline is attributed to broader market uncertainties and a volatile macroeconomic environment. The sky-high tariffs imposed by the United States and retaliatory tariffs by China and some other countries hurt global stock markets. Though the massive tariffs imposed by the United States and China are now on a pause, it is only a temporary suspension, and no one knows what will happen after the 90-day tariff suspension ends. The uncertainty around tariffs and trade production measures remains, slowing down economic growth. Although pharmaceuticals have been exempted from tariffs in the first round, they could be Trump's target in the next round, considering the President's goal to shift pharmaceutical production back to the United States, primarily from European and Asian countries. Trump and the Republican government also continue to stress on the control of drug prices with the latest attempt being his 'most favored nations' policy.' Let's understand AZN's strengths and weaknesses to better analyze how to play the stock in an uncertain macro environment. AstraZeneca boasts a diversified geographical footprint as well as a product portfolio with several blockbuster medicines. AstraZeneca now has 16 blockbuster medicines in its portfolio with sales exceeding $1 billion, including Tagrisso, Fasenra, Farxiga, Imfinzi, Lynparza (partnered with Merck [MRK]), Calquence and Ultomiris. These drugs are driving the company's top line, backed by increasing demand trends. The company is confident that the growth will continue in 2025. Almost every new product it has launched in recent years has done well. Newer drugs like Wainua, Airsupra, Saphnelo, Datroway (partnered with Daiichi Sankyo) and Truqap are also expected to continue to contribute to top-line growth in 2025. Oncology is AstraZeneca's biggest segment. The company is working on strengthening its oncology product portfolio through label expansions of existing products and progressing oncology pipeline candidates. Oncology sales (comprising around 41% of AstraZeneca's total revenues) rose 13% in the first quarter of 2025, generating $5.6 billion in sales. The strong oncology performance is being driven by medicines such as Tagrisso, Merck-partnered Lynparza, Imfinzi, Calquence and Daiichi Sankyo-partnered Enhertu. A key new cancer drug approval was that of Truqap for HR-positive, HER2-negative (HR+ HER2-) breast cancer. The drug has seen a robust launch, recording sales of $430 million in 2024 and $132 million in the first quarter of 2025. In January this year, AstraZeneca and partner Daiichi's drug, Datroway, was approved by the FDA for HR+ HER2- breast cancer, while a regulatory application is under review for EGFR-mutated non-small cell lung cancer (NSCLC). Datroway witnessed encouraging early launch signals in the United States. AstraZeneca expects continued growth of its oncology medicines in 2025, particularly Tagrisso, Enhertu and Imfinzi, despite the incremental impact of the Part D redesign. The impact of Part D redesign hurt sales of AZN's older drugs, Tagrisso, Lynparza and Ultomiris, as well as newer drugs, Truqap and Wainua, in the United States in the first quarter of 2025, with the trend expected to continue through the rest of the year. AstraZeneca expects Farxiga and Lynparza to be included in the volume-based procurement plans in China in mid-2025, which can hurt sales of these drugs in the country. Pricing and competitive pressure in Europe and generic competition in some emerging markets are expected to hurt sales of some drugs. Brilinta generics are expected to be launched in the United States in 2025. This will hurt sales of the drug. Biosimilar versions of Soliris were launched in the United States in March 2025, which, along with successful conversion to Ultomiris, biosimilar pressure in Europe and unfavorable order timing in certain tender markets, is expected to lead to a continuous decline in sales of Soliris. AstraZeneca is facing ongoing investigations at its China subsidiary. The Chinese authorities are investigating some current and former AstraZeneca employees at its China subsidiary for medical insurance fraud, illegal drug importation and personal information breaches. AZN stock has risen 8.2% so far this year againsta decrease of 3.1% for the industry. The stock has also outperformed the sector and S&P 500 index, as seen in the chart below. Image Source: Zacks Investment Research From a valuation standpoint, AstraZeneca is slightly expensive. Going by the price/earnings ratio, the company's shares currently trade at 14.93 forward earnings, slightly higher than 14.74 for the industry. However, AZN's stock is trading below its 5-year mean of 18.05. The stock is also much cheaper than other large drugmakers like Eli Lilly LLY and Novo Nordisk NVO. Eli Lilly and Novo Nordisk currently dominate the obesity space. Image Source: Zacks Investment Research The Zacks Consensus Estimate for 2025 earnings has risen from $4.47 per share to $4.50 per share over the past 60 days. For 2026, earnings estimates have risen from $4.95 per share to $4.98 per share over the same timeframe. Image Source: Zacks Investment Research Despite the potential impact from Part D redesign, AstraZeneca expects total revenues to grow by a high single-digit percentage at CER in 2025. Growth momentum in Oncology and CVRM(cardiovascular, renal and metabolism) segments is expected to continue in 2025. However, in Rare Disease, though AstraZeneca expects growth in 2025, it will be at a slower pace than in 2024. Regarding the potential impact of tariffs, AstraZeneca had a positive tone on the first-quarter conference call. The company said it has limited commercialized finished medicines imported to the United States from China, which lowers its exposure to potential China tariffs on pharmaceuticals. It also has a substantial and growing manufacturing footprint in the United States, and the majority of its medicines sold in the United States are manufactured domestically. It does import some medicines from Europe but believes that if tariffs on pharmaceutical imports from Europe are implemented in a similar range as other industries, it will be manageable and allow the company to remain within its guidance range for EPS. In 2025, AstraZeneca expects core EPS to increase by a low double-digit percentage. Backed by its new products and pipeline drugs, AstraZeneca believes it can post industry-leading top-line growth in the 2025-2030 period. AstraZeneca expects to generate$80 billion in total revenues by 2030, a significant increase from the $54 billion it generated in 2024. By the said time frame, AstraZeneca plans to launch 20 new medicines, with nine new medicines already launched/approved. It believes that many of these new medicines will have the potential to generate more than $5 billion in peak-year revenues. The company is also on track to achieve a mid-30s percentage core operating margin by 2026 Considering AZN's growth prospects, investors may take advantage of the recent dip and consider buying this Zacks Rank #2 (Buy) stock, more so as it is trading below its five-year mean. Consistently rising estimates also indicate analysts' optimistic outlook for growth. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report AstraZeneca PLC (AZN) : Free Stock Analysis Report Novo Nordisk A/S (NVO) : Free Stock Analysis Report Merck & Co., Inc. (MRK) : Free Stock Analysis Report Eli Lilly and Company (LLY) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research 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
05-05-2025
- Business
- Yahoo
FDA grants breakthrough status to Roche's VENTANA TROP2 device
The US Food and Drug Administration (FDA) has granted breakthrough device designation to Roche's computational pathology companion diagnostic (CDx) VENTANA TROP2 (EPR20043) RxDx device. Roche noted that this immunohistochemistry (IHC) assay is the first AI-driven companion diagnostic intended for use in determining non-small cell lung cancer (NSCLC). The VENTANA TROP2 device aims to help identify NSCLC subjects who are likely to benefit from Daiichi Sankyo and AstraZeneca's Trop2-directed antibody drug conjugate, Datroway's (datopotamab deruxtecan-dlnk) treatment. It is specifically indicated for patients with advanced or metastatic non-squamous NSCLC without actionable genomic alterations. The device comprises the TROP2 algorithm, Roche digital pathology scanners, navify Digital Pathology Image Management System, and the VENTANA TROP2 RxDx Assay, which is designed to work with the OptiView DAB Detection Kit to facilitate staining processes on the BenchMark ULTRA IHC/in situ hybridisation (ISH) staining instrument. It is designed to deliver a quantitative trophoblast cell surface antigen 2 (Trop2) score by analysing whole slide images of NSCLC tissue, which are stained with TROP2. Roche noted that incorporating AstraZeneca's Quantitative Continuous Scoring (QCS) platform, the algorithm achieves a level of diagnostic precision beyond traditional manual scoring methods. The breakthrough device status by the FDA will expedite the availability of the TROP2 CDx system. According to the company, a qualified pathologist plays a crucial role in reviewing staining and image quality, ensuring tumour detection sensitivity and precision. Following this assessment, the nDP TROP2 algorithm identifies tumour cells independently and calculates the normalised membrane ratio (NMR) score, classifying the TROP2 status as positive or negative based on a predefined cutoff. Roche Diagnostics CEO Matt Sause said: 'This FDA breakthrough device designation is another example of our commitment to deliver innovation that enables more precise diagnosis in oncology. 'This solution, which leverages our industry-leading expertise in companion diagnostics development, uses AI for a greater depth of sample analysis, helping to deliver truly personalised treatment.' Earlier this year, the company secured FDA 510(k) clearance for its Tina-quant Lipoprotein (a) Gen.2 Molarity assay. "FDA grants breakthrough status to Roche's VENTANA TROP2 device" was originally created and published by Medical Device Network, 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. Sign in to access your portfolio
Japan Times
31-01-2025
- Business
- Japan Times
AstraZeneca and Daiichi's breast cancer drug gets EU backing
AstraZeneca and Daiichi Sankyo's Datroway breast cancer treatment, which the companies expect will eventually become a blockbuster, was recommended for approval in the European Union. The green light from the European Medicines Agency is the first backing in the EU for the medicine, following its approval in the U.S. and Japan. Datroway is used to treat patients with a type of breast cancer that has spread or can't be removed by surgery, and whose cells bear a certain genetic signature. The treatment pairs a tumor-killing drug with an antibody designed to home in on cancerous tissue. In December, Astra and Daiichi withdrew an application in the EU for the drug to treat a type of lung cancer after feedback from regulatory advisers. Mixed results from a late-stage trial showed that, while some patients benefited from the drug, results across all patients weren't statistically significant. An earlier trial in a type of breast cancer also showed disappointing results. Still, Astra and Daiichi are optimistic about the use of Datroway to treat some patients with breast and lung cancers. The drug, previously called Dato-DXd, is among a group that Astra is counting on for peak annual sales of at least $5 billion, to help it reach $80 billion in annual revenue by the end of the decade.
Bloomberg
31-01-2025
- Business
- Bloomberg
AstraZeneca, Daiichi's Breast Cancer Drug Gets EU Backing
AstraZeneca Plc and Daiichi Sankyo Co. 's Datroway breast cancer treatment, which the companies expect will eventually become a blockbuster, was recommended for approval in the European Union. The green light from the European Medicines Agency is the first backing in the EU for the medicine, following its approval in the US and Japan.
