AstraZeneca Secures FDA Approval for Enhertu in First-Line Breast Cancer, Triggers $150M Milestone Payment
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 23 2025
0mins
Source: NASDAQ.COM
- FDA Approval: AstraZeneca and its partner Daiichi Sankyo's antibody-drug conjugate Enhertu has received FDA approval for first-line treatment of unresectable or metastatic HER2-positive breast cancer, marking a significant milestone in the U.S. market.
- Clinical Trial Results: The DESTINY-Breast09 study demonstrated that the Enhertu-Perjeta combination achieved a median progression-free survival of 40.7 months, a 51.5% improvement over the 26.9 months seen with the standard taxane chemotherapy, highlighting its superior efficacy.
- Financial Impact: This approval triggers a $150 million milestone payment from AstraZeneca to Daiichi Sankyo, further solidifying their global partnership and providing a new revenue growth avenue for AstraZeneca.
- Market Performance: Over the past year, AstraZeneca's stock has surged by 36.3%, significantly outperforming the industry average growth of 12.1%, reflecting strong market confidence in its newly approved drug and future growth potential.
Get Free Real-Time Notifications for Any Stock
Monitor tickers like AZN with instant alerts to capture every critical market movement.
Sign up for free to build your custom watchlist and receive professional-grade stock notifications.
Analyst Views on AZN
Wall Street analysts forecast AZN stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for AZN is 102.75 USD with a low forecast of 95.00 USD and a high forecast of 108.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
5 Analyst Rating
5 Buy
0 Hold
0 Sell
Strong Buy
Current: 93.220
Low
95.00
Averages
102.75
High
108.00
Current: 93.220
Low
95.00
Averages
102.75
High
108.00
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.
AstraZeneca Announces $15B Investment in China to Expand Operations
- Major Investment Plan: AstraZeneca has announced a $15 billion investment in China by 2030 to expand its drug manufacturing and R&D capabilities, marking the next phase of the company's development in China, which is expected to significantly enhance its cell therapy and radioconjugates capabilities.
- Strategic Market Positioning: China has become AstraZeneca's second-largest market, and this investment will further solidify its strategic hub status in global innovation, particularly with two global R&D centers in Beijing and Shanghai that have led 20 global clinical trials to date.
- Enhancing Public Health Contribution: CEO Pascal Soriot stated that this investment will strengthen AstraZeneca's contribution to high-quality development in China, especially in breakthrough treatment areas like cell therapy, bringing next-generation modalities to patients.
- Manufacturing and R&D Capacity Boost: This investment will not only increase the capacity of four manufacturing sites but also drive commercial operations across five regional hubs, further enhancing the company's competitiveness and influence in the Chinese market.
Continue Reading
CSPC Pharmaceutical Partners with AstraZeneca for Obesity Therapies
- Partnership Agreement: CSPC Pharmaceutical has signed an agreement with AstraZeneca to jointly develop innovative long-acting peptide therapies targeting obesity and related weight-management conditions, marking a significant collaboration in the biopharmaceutical sector.
- Upfront Payment and Potential Earnings: AstraZeneca will pay CSPC an upfront fee of $1.2 billion, with the potential for up to $3.5 billion in research and development milestone payments, indicating strong confidence in the project's viability.
- Sales Milestones and Royalties: The agreement includes up to $13.8 billion in sales-based milestone payments and double-digit percentage royalties tied to annual net sales of the licensed products, enhancing CSPC's revenue potential significantly.
- Broad Market Prospects: This collaboration not only aids CSPC in accumulating technological expertise in obesity treatment but also boosts its competitiveness in the global market, particularly in the rapidly growing health management sector.
Continue Reading