ENHERTU Shows Promising Results in Breast Cancer Treatment
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 1 hour ago
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Should l Buy AZN?
Source: Newsfilter
- Clinical Trial Results: The DESTINY-Breast05 phase 3 trial demonstrated that ENHERTU reduced the risk of invasive disease recurrence or death by 53% compared to T-DM1, indicating its potential as a new standard of care in early breast cancer treatment.
- Regulatory Progress: The European Medicines Agency has validated the marketing authorization application for ENHERTU, marking the commencement of the scientific review process, which is expected to expedite its availability for eligible patients in need of better treatment options.
- Patient Recruitment: The DESTINY-Breast05 trial enrolled 1,635 patients across Asia, Europe, and North America, showcasing the drug's broad applicability and potential market reach on a global scale.
- Future Development Directions: Additional regulatory submissions for ENHERTU are underway, including its combination with pertuzumab for the treatment of unresectable or metastatic HER2 positive breast cancer, highlighting its potential across multiple indications.
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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: 209.480
Low
157.61
Averages
213.64
High
252.18
Current: 209.480
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.
- Clinical Trial Results: The DESTINY-Breast05 phase 3 trial demonstrated that ENHERTU reduced the risk of invasive disease recurrence or death by 53% compared to T-DM1, indicating its potential as a new standard of care in early breast cancer treatment.
- Regulatory Progress: The European Medicines Agency has validated the marketing authorization application for ENHERTU, marking the commencement of the scientific review process, which is expected to expedite its availability for eligible patients in need of better treatment options.
- Patient Recruitment: The DESTINY-Breast05 trial enrolled 1,635 patients across Asia, Europe, and North America, showcasing the drug's broad applicability and potential market reach on a global scale.
- Future Development Directions: Additional regulatory submissions for ENHERTU are underway, including its combination with pertuzumab for the treatment of unresectable or metastatic HER2 positive breast cancer, highlighting its potential across multiple indications.
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- Collaborative Drug Development: AstraZeneca and Bristol Myers Squibb are partnering with Switzerland-based Evinova to leverage its AI-native platform for drug development, aiming to enhance research efficiency and reduce costs.
- Cost Savings in R&D: Evinova claims its platform can deliver at least 5%-7% savings per study, which will significantly improve the economic viability of drug development and enhance the competitive edge of the partners in the market.
- Intelligent Clinical Design: Evinova's AI digitizer capability converts clinical study designs, protocols, and documents into machine-readable formats, improving data processing efficiency and accelerating the drug development timeline.
- Multi-Partner Collaboration Model: The platform's flexible architecture enables a multi-model partner approach, providing access to advanced AI models and deep enterprise expertise, fostering smarter operational insights and driving innovation in the industry.
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Strategic Collaborations: EvinoVA has announced strategic collaborations with major pharmaceutical companies including Astellas, AstraZeneca, and Bristol Myers Squibb.
Focus on Clinical Development: These partnerships aim to advance EvinoVA's AI-native platform to accelerate global clinical development efforts.
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- Policy Advocacy: FDA Commissioner Marty Makary stated in Washington that the agency plans to push for more prescription drugs to become over-the-counter (OTC) this year, aiming to improve drug accessibility and reduce healthcare costs, which could allow patients to obtain basic safe medications without a doctor's visit.
- Regulatory Streamlining: Legislation passed by Congress in November simplifies the regulatory process for transitioning prescription drugs to OTC status, including full, conditional, and partial switch pathways, which is expected to accelerate drug availability and enhance patient convenience in medication access.
- Increased Transparency: Makary emphasized that OTC sales would bypass insurers and pharmacy benefit managers, potentially lowering drug prices and increasing transparency, with cash prices for OTC medications possibly being lower than patients' copays for prescription drugs, thereby alleviating financial burdens on patients.
- Industry Pushback: The pharmaceutical industry has raised concerns about this policy, arguing that OTC drugs may not be covered by insurance, leading to higher costs for patients, and that the FDA lacks authority over drug pricing, necessitating thorough consultations with manufacturers before any transitions.
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- Regulatory Reform Advocacy: FDA Commissioner Marty Makary asserts that all drugs should be over-the-counter unless deemed unsafe or addictive, aiming to enhance drug accessibility and reduce healthcare costs through streamlined regulatory processes.
- Drug Transition Process: The FDA is updating OTC monographs to transition basic, safe prescription drugs like nausea medications and vaginal estrogen to OTC status, allowing patients to obtain necessary medications without a doctor's visit.
- Industry Pushback: The pharmaceutical industry has expressed skepticism regarding the FDA's plans, arguing that many OTC drugs are not covered by insurance, potentially leading to higher costs for patients and decreased access to treatments.
- Transparency and Cost Control: Makary emphasizes that OTC sales will enhance price transparency, bypassing insurers and pharmacy benefit managers, thereby making drug prices more competitive and promoting patient adherence to medication regimens.
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- Bullish Outlook for Apple: Joshua Brown, CEO of Ritholtz Wealth Management, remains bullish on Apple, with Wedbush analyst Dan Ives reiterating an Outperform rating and maintaining a $350 price target, reflecting strong market confidence in Apple's growth potential.
- AstraZeneca's Solid Earnings: AstraZeneca reported Q4 2025 sales of $15.5 billion, a 4% year-over-year increase, nearly matching the consensus of $15.49 billion, with adjusted earnings of $2.12 per share exceeding expectations of $2.09, showcasing its competitive strength in the pharmaceutical sector.
- VICI Properties Rating Downgrade: Scotiabank analyst Nicholas Yulico downgraded VICI Properties from Sector Outperform to Sector Perform and lowered the price target from $36 to $30, indicating a cautious outlook on the company's future performance.
- Ulta Beauty's Middle East Expansion: Ulta Beauty announced its first store opening in the UAE at Mall of the Emirates on January 29, reflecting its strategic expansion into international markets, which could enhance brand visibility and market share.
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