US LNG exports surge but will buyers in China turn up?
AstraZeneca PLC (LSE/STO/Nasdaq: LON:AZN), a pharmaceutical giant with a market capitalization of $235 billion and currently trading above its InvestingPro Fair Value, has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), recommending approval of Enhertu as a monotherapy for certain breast cancer patients in the European Union (EU). The recommendation, announced today, specifically targets adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-low or HER2-ultralow breast cancer who have previously undergone at least one endocrine therapy.
This development follows the presentation of results from the DESTINY-Breast06 Phase III trial at the 2024 American Society of Clinical Oncology (ASCO) Meeting and their subsequent publication in The New England Journal of Medicine. The trial demonstrated that Enhertu, a HER2-directed antibody drug conjugate (ADC), significantly reduced the risk of disease progression or death by 38% compared to chemotherapy, achieving a median progression-free survival (PFS) of 13.2 months versus 8.1 months.
Susan Galbraith, Executive Vice President of Oncology Haematology R&D at AstraZeneca (NASDAQ:AZN), highlighted the potential for Enhertu to become the first HER2-directed treatment for this patient group in the EU following endocrine therapy. Ken Takeshita, Global Head of R&D at Daiichi Sankyo, expressed optimism about the CHMP recommendation supporting further development and advancement in breast cancer treatment classification.
The safety profile of Enhertu in the DESTINY-Breast06 trial was consistent with previous clinical trials, with no new safety concerns identified. Enhertu has already been approved in more than 75 countries, including the EU, for patients with HER2-low metastatic breast cancer based on the DESTINY-Breast04 trial results. As an InvestingPro tip indicates, AstraZeneca maintains a prominent position in the Pharmaceuticals industry, with impressive revenue growth of 18% and an industry-leading gross profit margin of 82%.
Approximately 85-90% of patients with HR-positive, HER2-negative metastatic breast cancer were determined to be HER2-low or HER2-ultralow, according to the trial data. The trial’s HER2 status confirmation was performed on tumor samples obtained at the initial metastatic diagnosis or later.
Enhertu is co-developed and commercialized by AstraZeneca and Daiichi Sankyo, with Daiichi Sankyo responsible for manufacturing and supply. The treatment is also under review in Japan and several other countries based on the DESTINY-Breast06 results.
The information in this article is based on a press release statement. According to InvestingPro data, AstraZeneca maintains a "GREAT" financial health score of 3.34, with 8 additional exclusive ProTips and comprehensive financial metrics available to subscribers. Access the detailed Pro Research Report, part of InvestingPro’s coverage of 1,400+ top stocks, for deeper insights into AstraZeneca’s market position and growth potential.
In other recent news, AstraZeneca has reported significant developments in its SERENA-6 Phase III trial, where the investigational drug camizestrant showed a meaningful improvement in progression-free survival for patients with HR-positive, HER2-negative advanced breast cancer. This trial represents a potential shift in treatment for patients with ESR1 mutations. Additionally, Moody’s has upgraded AstraZeneca’s senior unsecured ratings from A2 to A1, citing the company’s strong portfolio and pipeline, which supports robust growth in revenues and EBITDA. The company’s financial outlook is stable, with low leverage and a conservative financial policy.
Furthermore, AstraZeneca has announced the acquisition of FibroGen (NASDAQ:FGEN)’s China subsidiary for approximately $160 million, a move that will grant AstraZeneca all rights to the drug roxadustat in China. This transaction is expected to close by mid-2025, pending regulatory approval. AstraZeneca has also filed its 2024 Annual Report on Form 20-F with the U.S. Securities and Exchange Commission, providing a detailed overview of its financial performance and strategic direction. These developments reflect AstraZeneca’s ongoing efforts to redefine cancer care and maintain transparency with its shareholders.
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