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AstraZeneca PLC (LSE/STO/NASDAQ:LON:AZN), a prominent pharmaceutical company with a market capitalization of $220.46 billion and an impressive gross profit margin of 82.18%, has received a recommendation for approval from the European Union’s Committee for Medicinal Products for Human Use (CHMP) for its drug Calquence (acalabrutinib), to be used in a fixed-duration regimen for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL), as per a press release statement. According to InvestingPro analysis, AstraZeneca (NASDAQ:AZN) maintains a "GREAT" financial health score, positioning it strongly for continued market expansion.
The recommendation is based on the results of the AMPLIFY Phase III trial, which demonstrated that Calquence combinations significantly improved progression-free survival in comparison to chemoimmunotherapy. The trial’s findings were presented at the American Society of Haematology (ASH) 2024 Annual Meeting and published in The New England Journal of Medicine. This development comes as AstraZeneca reports strong revenue growth of 18.03% in the last twelve months, reflecting its successful commercialization strategy. For deeper insights into AstraZeneca’s financial metrics and growth potential, investors can access comprehensive analysis through InvestingPro, which offers exclusive ProTips and detailed financial health assessments.
Patients treated with Calquence in combination with venetoclax, with or without obinutuzumab, showed a reduced risk of disease progression or death by 35% to 58% versus those treated with chemoimmunotherapy. At three years, 77% to 83% of patients on the Calquence regimen were progression free, compared to 67% on chemoimmunotherapy.
Dr. Wojciech Jurczak, an investigator for the trial, highlighted the benefit of fixed-duration regimens, which can allow patients to take breaks from treatment, potentially reducing long-term adverse events and drug resistance.
Susan Galbraith, Executive Vice President of AstraZeneca’s Oncology Haematology R&D, expressed that this recommendation could make Calquence plus venetoclax the only all-oral second-generation BTK inhibitor option approved in Europe for this patient population.
The safety profile of Calquence was consistent with previously known data, with no new safety signals identified. Regulatory applications based on the AMPLIFY results are currently under review in several countries.
CLL is the most common type of leukaemia in adults, with approximately 27,000 patients diagnosed in the UK, France, Germany, Spain, and Italy in 2024 alone. Calquence, a second-generation BTK inhibitor, is already approved for the treatment of CLL and small lymphocytic lymphoma (SLL) in various regions, including the US, Japan, and China, and for CLL in the EU.
AstraZeneca continues to explore the potential of Calquence in a comprehensive clinical development program for multiple B-cell blood cancers. The company’s strong financial position, with sufficient cash flows to cover interest payments and a moderate debt level, supports its ongoing research and development initiatives. InvestingPro analysis suggests the stock is currently trading below its Fair Value, presenting a potential opportunity for investors interested in the pharmaceutical sector. The company’s 33-year track record of consistent dividend payments further demonstrates its financial stability and commitment to shareholder returns.
In other recent news, AstraZeneca has reported a significant breakthrough in breast cancer treatment with its drug Enhertu, which, in combination with pertuzumab, has shown a meaningful improvement in progression-free survival for patients with HER2-positive metastatic breast cancer. The findings from the DESTINY-Breast09 Phase III trial mark the first time in over a decade that a treatment has demonstrated superior efficacy across a broad patient population compared to the current first-line standard of care. Meanwhile, AstraZeneca faced a setback as it discontinued the CAPItello-280 Phase III trial for its prostate cancer drug Truqap, following recommendations from an Independent (LON:IOG) Data Monitoring Committee. In a separate development, AstraZeneca has entered a strategic collaboration with Tempus AI and Pathos AI to create a multimodal foundation model in oncology, enhancing drug discovery and patient care. Tempus AI is set to receive $200 million for data licensing and model development fees. Additionally, BNP Paribas (OTC:BNPQY) Exane has initiated coverage of AstraZeneca with an "Outperform" rating, citing a positive outlook on the company’s revenue potential and strategic initiatives. In related company news, STAAR Surgical (NASDAQ:STAA) Company has reshuffled its Board of Directors to strengthen its focus on the Asia Pacific market, appointing Louis E. Silverman and assigning Wei Jiang as a special strategic advisor for the region. These developments reflect the ongoing strategic efforts by these companies to enhance their market positions and advance their research and development initiatives.
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