AstraZeneca’s Calquence Regimen Receives EU Approval Recommendation for CLL

PUBLISHED: 29 Apr 2025 @ 18:14 | Comments (0) | More info about Fiona Craig

AstraZeneca (LSE:AZN) has announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of a fixed-duration regimen of its drug Calquence, in combination with venetoclax, with or without obinutuzumab, for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL) in the European Union. This recommendation follows the positive results from the AMPLIFY Phase III trial, which demonstrated significant improvements in progression-free survival compared to standard chemoimmunotherapy. If approved, this regimen could position Calquence as a leading treatment option in Europe, providing patients with a more flexible and potentially safer alternative.

Financial Outlook and Market Impact

AstraZeneca continues to show strong financial performance, bolstered by solid revenue and earnings per share (EPS) growth. While the company faces some short-term challenges, including technical signals of potential weakness and concerns over its stock valuation, the long-term outlook remains positive. Ongoing regulatory hurdles, particularly in China, and potential risks in other markets should be considered, but the company’s strategic initiatives and recent drug approvals provide a promising foundation for future growth.

About AstraZeneca

AstraZeneca is a global, science-led biopharmaceutical company based in Cambridge, UK, with a focus on discovering, developing, and commercializing prescription medicines. The company specializes in Oncology, Rare Diseases, and BioPharmaceuticals, which includes Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. AstraZeneca’s medicines are sold in over 125 countries and are used by millions of patients worldwide.

Market Snapshot

Year-to-Date Price Performance: 0.80%
Average Trading Volume: 2,918,273 shares
Technical Sentiment: Hold
Market Capitalization: £161.3 billion

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