Welcome to our dedicated page for AstraZeneca news (Ticker: AZN), a resource for investors and traders seeking the latest updates and insights on AstraZeneca stock.
AstraZeneca PLC (AZN) generates a steady flow of news driven by its global biopharmaceutical activities in Oncology, Rare Diseases and BioPharmaceuticals. Company announcements frequently cover clinical trial milestones, regulatory decisions, manufacturing investments and strategic collaborations, offering investors and healthcare professionals insight into how its pipeline and marketed medicines are evolving.
Recent news highlights include multiple updates on Enhertu (trastuzumab deruxtecan) and Datroway (datopotamab deruxtecan), two antibody drug conjugates jointly developed with Daiichi Sankyo. These stories describe new Phase 3 trials, Breakthrough Therapy Designations, and approvals in indications such as HER2-positive early breast cancer, metastatic breast cancer, HER2-expressing endometrial cancer and HER2-expressing ovarian cancer, as well as TROP2-directed approaches in lung and breast cancer.
News items also cover immuno-oncology developments with Imfinzi (durvalumab), including perioperative regimens for gastric and gastroesophageal junction cancers based on the MATTERHORN trial, and broader use in gastrointestinal and thoracic malignancies. In Rare Diseases and immunology, AstraZeneca reports on approvals for Koselugo in adult NF1-associated plexiform neurofibromas and on expanded administration options for Saphnelo in systemic lupus erythematosus.
Beyond clinical and regulatory updates, AstraZeneca’s news feed includes information on large-scale manufacturing investments in the United States, such as expansion of biologics facilities in Maryland, and technology partnerships like the selection of Salesforce’s Agentforce Life Sciences platform for AI-powered customer engagement. Visitors to this AZN news page can review these developments to understand how AstraZeneca’s pipeline, approvals and infrastructure may influence its long-term strategic direction.
DATROWAY® (datopotamab deruxtecan) has received EU approval for treating adult patients with unresectable or metastatic HR positive, HER2 negative breast cancer who have undergone endocrine therapy and at least one chemotherapy line in advanced settings. The approval is based on the TROPION-Breast01 phase 3 trial results.
Key findings show DATROWAY reduced disease progression or death risk by 37% compared to standard chemotherapy. The median progression-free survival was 6.9 months for DATROWAY versus 4.9 months with chemotherapy. The objective response rate was 36% for DATROWAY compared to 23% for chemotherapy, with a median duration of response of 6.7 months versus 5.7 months respectively.
Overall survival results were not statistically significant, with median OS of 18.6 months for DATROWAY versus 18.3 months for chemotherapy. The most common Grade 3 or higher adverse events included stomatitis (7.9%), fatigue (4.3%), and anemia (3.2%).
ENHERTU® has received EU approval as the first HER2-directed therapy for patients with HR positive, HER2 low or HER2 ultralow metastatic breast cancer who have received at least one endocrine therapy. The approval is based on the DESTINY-Breast06 phase 3 trial results, where ENHERTU showed:
- 38% reduction in disease progression or death risk vs chemotherapy
- Median progression-free survival of 13.2 months vs 8.1 months with chemotherapy
- Objective response rate of 56.5% vs 32.2% with chemotherapy
The approval expands ENHERTU's use to earlier treatment settings and broadens eligible patients to include HER2 ultralow disease. HR positive, HER2 negative represents approximately 70% of all breast cancers. Following this approval, AstraZeneca will pay Daiichi Sankyo a $125 million milestone payment.
AstraZeneca's AZD0780, a novel once-daily oral PCSK9 inhibitor, demonstrated significant results in the PURSUIT Phase IIb trial. The drug achieved a 50.7% reduction in LDL-C when administered with standard-of-care statin therapy, compared to placebo over 12 weeks.
The trial showed that 84% of participants receiving AZD0780 30mg reached their recommended LDL-C target (70 mg/dL), versus only 13% in the control group. The effectiveness was consistent across moderate and high-intensity statin doses. The drug was generally well-tolerated, with adverse events comparable between treatment (38.2%) and placebo (32.6%) groups, and similar discontinuation rates (1.5% vs 2.3%).
DESTINY-Gastric05, a new phase 3 trial, has commenced with the first patient dosed to evaluate ENHERTU® (trastuzumab deruxtecan) in combination therapy for previously untreated HER2 positive advanced gastric cancer. The study will test ENHERTU with fluoropyrimidine chemotherapy and KEYTRUDA® versus the current standard treatment.
The trial focuses on patients with unresectable, locally advanced or metastatic HER2 positive gastric or gastroesophageal junction cancer with PD-L1 CPS ≥1. An exploratory cohort with PD-L1 CPS 1 will also be included. This initiative follows positive survival results from DESTINY-Gastric04 in second-line treatment.ENHERTU, a HER2 directed DXd antibody drug conjugate jointly developed by Daiichi Sankyo and AstraZeneca, is currently approved in over 65 countries for second-line or third-line metastatic HER2 positive gastric cancer treatment.
AstraZeneca's IMFINZI (durvalumab) has received FDA approval as the first perioperative immunotherapy for muscle-invasive bladder cancer (MIBC) treatment in the US. The approval is based on the NIAGARA Phase III trial results, which demonstrated:
- 32% reduction in disease progression risk
- 25% reduction in death risk
- 67.8% of treated patients were event-free at two years
- 82.2% survival rate at two years
The treatment combines IMFINZI with gemcitabine and cisplatin before surgery, followed by IMFINZI monotherapy after bladder removal surgery. The therapy addresses a significant need, as over 20,000 people in the US were treated for MIBC in 2024. The treatment was well-tolerated, with manageable and mostly low-grade immune-mediated adverse events.
Lunit (KRX:328130.KQ) and AstraZeneca (AZN) will present a collaborative AI study at AACR 2025, showcasing the Lunit SCOPE Genotype Predictor. This deep learning model predicts EGFR mutations in non-small cell lung cancer (NSCLC) patients using H&E-stained tissue samples.
The study utilized the largest diverse training dataset to date, comprising over 12,000 pathology slides (>4,500 EGFR-mutated and >7,500 wild-type) from NSCLC patients across the US, China, and South Korea. The AI model demonstrated consistent performance across various clinical variables, including specimen types, EGFR mutation subtypes, slide scanners, and scan magnifications.
The technology aims to address current limitations in molecular testing accessibility for NSCLC patients, offering a rapid and cost-effective solution for predicting driver mutations. The presentation will take place at the AACR Annual Meeting from April 25-30, 2025, in Chicago.
AstraZeneca presented new study results at ELCC 2025 reinforcing TAGRISSO® (osimertinib) as a cornerstone therapy for EGFR-mutated non-small cell lung cancer (NSCLC). Key findings include:
The LAURA Phase III trial showed improved overall survival trend with TAGRISSO vs placebo in unresectable Stage III setting (58.8 vs 54.1 months). The SAVANNAH Phase II trial demonstrated 56% response rate combining TAGRISSO with savolitinib in patients with high MET levels after disease progression. The ORCHARD trial showed promising results combining TAGRISSO with datopotamab deruxtecan-dlnk, achieving up to 43% response rate.
The FLAURA2 trial analysis revealed progression-free survival of over two years when combining TAGRISSO with chemotherapy. Safety profiles across all trials were consistent with established data, though monitoring is required for potential serious side effects including interstitial lung disease, QT interval prolongation, and cardiomyopathy.
IgniteData has partnered with AstraZeneca (AZN) and Cambridge University Hospitals NHS Foundation Trust (CUH) to implement its Archer platform in an ongoing Phase 3 study. The platform automates data transfer between hospital Electronic Health Records and sponsor Electronic Data Capture systems.
The collaboration, which began in 2021, follows successful pilot studies at University College London Hospitals and Memorial Sloan Kettering Cancer Center. Archer's system-agnostic design can map hundreds of data points per patient while maintaining data security and privacy.
The platform aims to reduce time spent on manual data entry, allowing researchers to focus more on clinical research. This implementation at Cambridge marks a significant step in scaling the technology across NHS and European hospitals for future clinical trials.
AstraZeneca (AZN) has partnered with national sports broadcaster and cancer survivor Erin Andrews to launch the 'Get Body Checked Against Cancer' campaign, aimed at promoting early cancer detection. The initiative includes the release of a -edition t-shirt called SCREEN under Andrews' WEAR by EA brand, available at NHLshop.com and the NHL Flagship Store in NYC.
The campaign supports Hockey Fights Cancer™, a joint initiative with the NHL and NHLPA. AstraZeneca has already donated $500,000 to the V Foundation for Cancer Research. The company is also introducing the Body Check Cup, a league-wide challenge running from March 6 to April 7, where NHL team fans can pledge to discuss cancer screenings with their doctors.
A concerning statistic reveals that 65% of Americans aged 21 and older are not up to date on at least one routine cancer screening, highlighting the campaign's importance in promoting proactive healthcare.
AstraZeneca announced positive results from the MATTERHORN Phase III trial evaluating IMFINZI® (durvalumab) in combination with FLOT chemotherapy for resectable early-stage gastric and gastroesophageal junction (GEJ) cancers.
The trial demonstrated a statistically significant improvement in event-free survival (EFS) when using IMFINZI plus chemotherapy before and after surgery, followed by IMFINZI monotherapy. The study also showed a strong trend favoring IMFINZI in overall survival at interim analysis.
Notably, the IMFINZI combination more than doubled the pathologic complete response rate (19% versus 7%) compared to neoadjuvant chemotherapy alone. The safety profile remained consistent with known profiles of each medicine, with no new safety findings.
This marks the first Phase III trial demonstrating superior EFS with immunotherapy combination in this setting. The disease affects nearly one million people globally annually, with approximately 62,000 new diagnoses expected in the US, EU, and Japan by 2030 in early-stage and locally advanced cases.