FDA Approves AstraZeneca's Blockbuster Cancer Drug, Imfinzi, In Combination With Chemo For Non-Small Cell Lung Cancer
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Aug 16 2024
0mins
Should l Buy AZN?
Source: Benzinga
FDA Approval of Imfinzi: The FDA has approved AstraZeneca's Imfinzi in combination with chemotherapy for adult patients with resectable early-stage non-small cell lung cancer, showing a significant reduction in the risk of recurrence and improved pathologic complete response rates compared to chemotherapy alone.
Upcoming Regulatory Review: A supplemental marketing application for Imfinzi in limited-stage small cell lung cancer has been accepted by the FDA, with a decision expected in Q4 2024; the application is based on data demonstrating improved overall survival and progression-free survival compared to placebo.
Trade with 70% Backtested Accuracy
Stop guessing "Should I Buy AZN?" and start using high-conviction signals backed by rigorous historical data.
Sign up today to access powerful investing tools and make smarter, data-driven decisions.
Analyst Views on AZN
Wall Street analysts forecast AZN stock price to rise
14 Analyst Rating
13 Buy
0 Hold
1 Sell
Strong Buy
Current: 204.520
Low
157.61
Averages
213.64
High
252.18
Current: 204.520
Low
157.61
Averages
213.64
High
252.18
About AZN
AstraZeneca PLC is a United Kingdom-based science-led biopharmaceutical company. The Company focuses on the discovery, development, and commercialization of prescription medicines. The Company operates across therapy areas, including Oncology; Cardiovascular, Renal and Metabolism (CVRM); Respiratory and Immunology (R&I); Vaccines and Immune Therapies (V&I), and Rare Disease. In the Oncology area, its key products include Tagrisso, Imfinzi, Calquence, Lynparza, and Enhertu. The key products of CVRM area include Farxiga/Forxiga, Brilinta/Brilique, Crestor, and Lokelma. In the R&I area, the key products are Symbicort, Fasenra, Breztri/Trixeo, and Tezspire. In the V&I Therapies area, the products are Beyfortus and FluMist. The products in the Rare Disease area are Ultomiris, Soliris, Strensiq, and Koselugo. It has about 191 projects in its development pipeline, including 19 new molecular entities (NMEs) in the late-stage pipeline. The Company distributes its products in over 125 countries.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Goldman Sachs Updates 10-Year Global Equity Forecast
- Optimistic European Outlook: Goldman Sachs projects a 7.5% annual return for European stocks over the next decade, driven by strong earnings growth and a dividend yield of about 3%, which is likely to attract more investor interest in the European market.
- Emerging Market Potential: Emerging market stocks are expected to return 12.8% annually, primarily supported by robust earnings growth in China and India, highlighting the significance and appeal of these markets in the global economy.
- Vanguard ETF Advantages: The Vanguard FTSE Europe ETF boasts an expense ratio of just 0.06%, significantly lower than the average 0.81% for similar funds, providing investors with a cost-effective avenue for European stock exposure, thereby enhancing its market competitiveness.
- US vs. European Stocks: While US stocks outperformed European stocks over the past decade, Goldman believes that due to high valuations in the US market, European stocks may surpass them in the next decade, prompting investors to reassess their asset allocation strategies.
See More
Health Care Stocks Rise as NYSE Index Gains 1.1%
- Strong Performance in Health Care: Health care stocks rose on Friday afternoon, with the NYSE Health Care Index gaining 1.1%, reflecting increased investor confidence in the sector, likely driven by an overall improvement in market sentiment.
- Market Sentiment Recovery: The rise in health care stocks may be correlated with a broader market recovery trend, as investors reassess the investment value of the health care sector after recent volatility, indicating optimism about future growth potential.
- Increased Investor Attention: With ongoing innovations and policy support in the health care industry, investor attention towards health care stocks has significantly increased, potentially attracting more capital into the sector and driving stock prices higher.
- Optimistic Industry Outlook: The growth potential and stability of the health care sector make it attractive amid economic uncertainties, leading investors to view it as a safe haven, further propelling the upward trend in health care stocks.
See More
AstraZeneca's BREZTRI Shows Significant Asthma Improvement in Phase III Trials
- Clinical Trial Results: AstraZeneca's BREZTRI demonstrated significant lung function improvements in the KALOS and LOGOS Phase III trials, with a 76 mL increase in FEV1 over 24 weeks compared to dual therapy, highlighting its potential in asthma management.
- Reduction in Severe Exacerbations: The pooled analysis from both trials showed that BREZTRI significantly reduced the annualized rate of severe asthma exacerbations, underscoring its importance in patient care and management.
- Global Market Potential: Approved in over 80 countries for COPD treatment, BREZTRI's ongoing regulatory filings for asthma indications are expected to further expand its market reach and patient access.
- R&D Outlook: AstraZeneca executives noted that BREZTRI's success could enhance the quality of life for millions of asthma patients globally, emphasizing the company's leadership and commitment to innovation in respiratory therapeutics.
See More
AstraZeneca Announces BrePREMIUM Trial Results
- Trial Results Announced: AstraZeneca announced on Friday the pooled results from its phase 3 Kalos and Logos trials, indicating the efficacy and safety of BrePREMIUM, although specific data has not been disclosed, which has drawn market attention.
- Market Reaction: The news did not significantly impact AstraZeneca's stock price, reflecting investor caution regarding drug development progress, which may affect the company's future market performance.
- R&D Strategy: AstraZeneca continues to advance its innovative drug development, with BrePREMIUM being a crucial component of its product line, potentially playing a key role in future market competition.
- Regulatory Outlook: With the trial results announced, AstraZeneca may expedite communication with regulatory agencies to seek swift approval, further enhancing its positioning in the biopharmaceutical sector.
See More
Analyzing Earnings in the Healthcare Sector: AZN, EW, and ZBH Compared
Earnings Reports in Healthcare Sector: Companies in the healthcare sector are reporting earnings that provide insights into their development progress and potential growth opportunities, particularly with the release of new drugs and medical devices.
AstraZeneca's Strong Performance: AstraZeneca reported a strong quarterly performance, with significant sales growth driven by its cancer medicines, which accounted for a large portion of its revenue, prompting positive investor sentiment.
Zimmer Biomet's Market Position: Zimmer Biomet is experiencing high demand for its orthopedic products, contributing to revenue growth, although it faces challenges from tariffs that may impact future earnings.
Investment Recommendations: Analysts are recommending specific stocks in the healthcare sector for investors to consider, highlighting potential growth opportunities and the importance of monitoring earnings and market conditions.
See More
CSPC Unveils Record Licensing Deal with AstraZeneca Amid Stock Decline
- Deal Details: CSPC's collaboration with AstraZeneca grants the latter exclusive global rights to CSPC's developing anti-obesity drugs, including SYH2082, yet the market's tepid response has led to a stock price decline following the announcement.
- Financial Performance Pressure: CSPC reported a 12.32% year-over-year revenue drop to 19.89 billion yuan and a 7.1% decline in net profit to 3.51 billion yuan in the first three quarters of 2025, highlighting the severe impact of China's centralized procurement policies on its core drug business.
- Executive Changes and Strategic Shift: The appointment of Cai Lei as CEO signals CSPC's commitment to accelerating its transition to innovative drugs, leveraging his experience from the U.S. R&D division to enhance global competitiveness.
- Market Reaction and Governance Risks: Despite the licensing deal's potential value of $18.5 billion, investor confidence has been undermined by corporate governance issues and insider trading scandals, resulting in a stock price drop post-announcement.
See More
Goldman Sachs Updates 10-Year Global Equity Forecast
- Optimistic European Outlook: Goldman Sachs projects a 7.5% annual return for European stocks over the next decade, driven by strong earnings growth and a dividend yield of about 3%, which is likely to attract more investor interest in the European market.
- Emerging Market Potential: Emerging market stocks are expected to return 12.8% annually, primarily supported by robust earnings growth in China and India, highlighting the significance and appeal of these markets in the global economy.
- Vanguard ETF Advantages: The Vanguard FTSE Europe ETF boasts an expense ratio of just 0.06%, significantly lower than the average 0.81% for similar funds, providing investors with a cost-effective avenue for European stock exposure, thereby enhancing its market competitiveness.
- US vs. European Stocks: While US stocks outperformed European stocks over the past decade, Goldman believes that due to high valuations in the US market, European stocks may surpass them in the next decade, prompting investors to reassess their asset allocation strategies.
See More
Health Care Stocks Rise as NYSE Index Gains 1.1%
- Strong Performance in Health Care: Health care stocks rose on Friday afternoon, with the NYSE Health Care Index gaining 1.1%, reflecting increased investor confidence in the sector, likely driven by an overall improvement in market sentiment.
- Market Sentiment Recovery: The rise in health care stocks may be correlated with a broader market recovery trend, as investors reassess the investment value of the health care sector after recent volatility, indicating optimism about future growth potential.
- Increased Investor Attention: With ongoing innovations and policy support in the health care industry, investor attention towards health care stocks has significantly increased, potentially attracting more capital into the sector and driving stock prices higher.
- Optimistic Industry Outlook: The growth potential and stability of the health care sector make it attractive amid economic uncertainties, leading investors to view it as a safe haven, further propelling the upward trend in health care stocks.
See More
AstraZeneca's BREZTRI Shows Significant Asthma Improvement in Phase III Trials
- Clinical Trial Results: AstraZeneca's BREZTRI demonstrated significant lung function improvements in the KALOS and LOGOS Phase III trials, with a 76 mL increase in FEV1 over 24 weeks compared to dual therapy, highlighting its potential in asthma management.
- Reduction in Severe Exacerbations: The pooled analysis from both trials showed that BREZTRI significantly reduced the annualized rate of severe asthma exacerbations, underscoring its importance in patient care and management.
- Global Market Potential: Approved in over 80 countries for COPD treatment, BREZTRI's ongoing regulatory filings for asthma indications are expected to further expand its market reach and patient access.
- R&D Outlook: AstraZeneca executives noted that BREZTRI's success could enhance the quality of life for millions of asthma patients globally, emphasizing the company's leadership and commitment to innovation in respiratory therapeutics.
See More
AstraZeneca Announces BrePREMIUM Trial Results
- Trial Results Announced: AstraZeneca announced on Friday the pooled results from its phase 3 Kalos and Logos trials, indicating the efficacy and safety of BrePREMIUM, although specific data has not been disclosed, which has drawn market attention.
- Market Reaction: The news did not significantly impact AstraZeneca's stock price, reflecting investor caution regarding drug development progress, which may affect the company's future market performance.
- R&D Strategy: AstraZeneca continues to advance its innovative drug development, with BrePREMIUM being a crucial component of its product line, potentially playing a key role in future market competition.
- Regulatory Outlook: With the trial results announced, AstraZeneca may expedite communication with regulatory agencies to seek swift approval, further enhancing its positioning in the biopharmaceutical sector.
See More
Analyzing Earnings in the Healthcare Sector: AZN, EW, and ZBH Compared
Earnings Reports in Healthcare Sector: Companies in the healthcare sector are reporting earnings that provide insights into their development progress and potential growth opportunities, particularly with the release of new drugs and medical devices.
AstraZeneca's Strong Performance: AstraZeneca reported a strong quarterly performance, with significant sales growth driven by its cancer medicines, which accounted for a large portion of its revenue, prompting positive investor sentiment.
Zimmer Biomet's Market Position: Zimmer Biomet is experiencing high demand for its orthopedic products, contributing to revenue growth, although it faces challenges from tariffs that may impact future earnings.
Investment Recommendations: Analysts are recommending specific stocks in the healthcare sector for investors to consider, highlighting potential growth opportunities and the importance of monitoring earnings and market conditions.
See More
CSPC Unveils Record Licensing Deal with AstraZeneca Amid Stock Decline
- Deal Details: CSPC's collaboration with AstraZeneca grants the latter exclusive global rights to CSPC's developing anti-obesity drugs, including SYH2082, yet the market's tepid response has led to a stock price decline following the announcement.
- Financial Performance Pressure: CSPC reported a 12.32% year-over-year revenue drop to 19.89 billion yuan and a 7.1% decline in net profit to 3.51 billion yuan in the first three quarters of 2025, highlighting the severe impact of China's centralized procurement policies on its core drug business.
- Executive Changes and Strategic Shift: The appointment of Cai Lei as CEO signals CSPC's commitment to accelerating its transition to innovative drugs, leveraging his experience from the U.S. R&D division to enhance global competitiveness.
- Market Reaction and Governance Risks: Despite the licensing deal's potential value of $18.5 billion, investor confidence has been undermined by corporate governance issues and insider trading scandals, resulting in a stock price drop post-announcement.
See More
