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AstraZeneca PLC (LSE/STO/Nasdaq: LON:AZN), a prominent pharmaceutical company with a market capitalization of $225 billion and an impressive gross profit margin of 82%, has reached a significant milestone as the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended its drug Calquence (acalabrutinib) for approval in the European Union (EU) as a first-line treatment for adult patients with previously untreated mantle cell lymphoma (MCL) who are ineligible for stem cell transplantation. According to InvestingPro analysis, AstraZeneca (NASDAQ:AZN) maintains strong financial health with a "GREAT" overall score, positioning it well for continued growth in the pharmaceutical sector. The recommendation, announced today, is based on the ECHO Phase III trial results, which showed a notable improvement in progression-free survival when Calquence was used in combination with bendamustine and rituximab, compared to chemoimmunotherapy alone.
The ECHO trial, presented at the European Hematology Association 2024 Congress, demonstrated that the Calquence combination reduced the risk of disease progression or death by 27% and improved median progression-free survival to 66.4 months from 49.6 months for the standard chemoimmunotherapy. This recommendation follows a recent positive opinion for Calquence as a monotherapy for relapsed or refractory MCL. The company’s robust revenue growth of 18% in the last twelve months reflects its successful drug development strategy. For deeper insights into AstraZeneca’s financial performance and growth prospects, InvestingPro subscribers can access comprehensive analysis and 8 additional ProTips.
Martin Dreyling, MD, from the University Hospital LMU Munich and an investigator in the trial, highlighted the importance of the recommendation for older patients who require both efficacy and tolerability in treatment. Susan Galbraith, Executive Vice President of Oncology R&D at AstraZeneca, emphasized the potential of Calquence to transform the standard of care for MCL patients in Europe.
MCL is a rare, typically aggressive form of non-Hodgkin lymphoma that is often diagnosed at an advanced stage. In 2024, it was estimated that over 6,000 patients were diagnosed with MCL in key European countries. The safety profile of Calquence was consistent with previous findings, with no new safety concerns identified. With a strong track record of maintaining dividend payments for 33 consecutive years and operating with moderate debt levels, AstraZeneca demonstrates financial stability in its pursuit of medical breakthroughs. Detailed financial metrics and valuation analysis are available through InvestingPro’s comprehensive research reports.
Calquence, a second-generation BTK inhibitor, is already approved in the US and several other countries for the treatment of MCL and is undergoing regulatory review in Japan and other regions. This drug is part of AstraZeneca’s extensive clinical development program aimed at multiple B-cell blood cancers.
The positive CHMP opinion is a critical step towards full EU approval, which could significantly impact the treatment landscape for MCL patients. This news is based on a press release statement.
In other recent news, AstraZeneca has received U.S. Food and Drug Administration (FDA) approval for its drug Imfinzi as a treatment for muscle-invasive bladder cancer (MIBC). This approval is based on the results of the Phase III NIAGARA trial, which demonstrated a 32% reduction in the risk of disease recurrence and a 25% reduction in the risk of death compared to chemotherapy alone. The treatment regimen involves Imfinzi in combination with gemcitabine and cisplatin before surgery, followed by Imfinzi alone after surgery. The trial showed that approximately 80% of patients treated with this regimen were still alive two years later.
Additionally, Goldman Sachs has maintained its Conviction Buy rating on AstraZeneca, citing the potential growth in the oral PCSK9 inhibitor market with AZD0780. The firm has also raised its price target for AstraZeneca shares, reflecting optimism about the upcoming Phase 2 PURSUIT trial data for AZD0780. This data is anticipated to influence the competitive landscape for cardiovascular drugs. AstraZeneca’s focus on oral therapies, including AZD0780, is seen as a strategic move to improve patient convenience and adherence.
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