ENHERTU® and THP Supplemental Biologics License Application Approved in the U.S. for High-Risk HER2 Positive Early-Stage Breast Cancer Patients Before Surgery
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Oct 01 2025
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Source: Newsfilter
ENHERTU's Approval Status: Daiichi Sankyo and AstraZeneca's ENHERTU has been accepted for review by the FDA for neoadjuvant treatment of HER2 positive early-stage breast cancer, based on positive results from the DESTINY-Breast11 phase 3 trial showing improved pathologic complete response rates and safety compared to standard treatments.
Clinical Significance: Achieving a pathologic complete response (pCR) is crucial for patients with high-risk HER2 positive early-stage breast cancer, as it is associated with better long-term outcomes, addressing the unmet medical need for effective treatment options in this patient population.
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: 91.690
Low
95.00
Averages
102.75
High
108.00
Current: 91.690
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.
