AstraZeneca's SBLA for Enhertu and Pertuzumab Combination Receives Priority Review Status in the US
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Sep 24 2025
0mins
Source: NASDAQ.COM
Regulatory Approval: AstraZeneca and Daiichi Sankyo's supplemental Biologics License Application for Enhertu, in combination with pertuzumab, has been accepted for Priority Review by the FDA for treating HER2-positive breast cancer.
Clinical Trial Basis: The application is based on results from the DESTINY-Breast09 Phase III trial, with a regulatory decision expected in the first quarter of 2026.
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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.
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AstraZeneca Announces $15 Billion Investment in China
- Investment Scale: AstraZeneca has announced a $15 billion investment in China by 2030 to expand its medicines manufacturing and R&D capabilities, further solidifying its market position in the region.
- UK-China Collaboration: This investment was announced during the UK Prime Minister's visit to China, expected to strengthen collaboration in healthcare innovation and promote the development of life sciences ecosystems in both countries.
- Job Creation: AstraZeneca's investment will grow its highly skilled workforce in China to over 20,000 and create thousands of additional jobs across the healthcare ecosystem, supporting job growth in the UK.
- Enhanced R&D Capabilities: The investment will significantly enhance AstraZeneca's capabilities in cell therapy and radioconjugates, leveraging its global strategic R&D centers in Beijing and Shanghai, which collaborate with over 500 clinical hospitals to advance global clinical trials.
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