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.
AstraZeneca (NYSE:AZN) reported 9M 2025 Total Revenue of $43,236m, up 11% CER, driven by Product Revenue of $43,143m. Core EPS rose 15% to $7.04 and Reported EPS was $5.10. Oncology revenue grew 16% and R&I grew 13%. The company announced 16 positive Phase III readouts and 31 approvals in major regions year-to-date. Guidance for FY 2025 at CER was reiterated: Total Revenue expected to increase by a high single-digit percentage and Core EPS by a low double-digit percentage. Corporate updates include a harmonised global listing effective 2 Feb 2026 and a $4.5bn Virginia plant as part of a $50bn US investment plan to 2030.
AstraZeneca (AZN) and Daiichi Sankyo announced that the first patient has been dosed in DESTINY-Lung06, a Phase 3 trial testing ENHERTU (trastuzumab deruxtecan) plus pembrolizumab versus pembrolizumab with platinum-based chemotherapy and pemetrexed as first-line treatment for unresectable, locally advanced or metastatic HER2 overexpressing, non-squamous NSCLC with PD-L1 TPS <50%.
The trial replaces traditional chemotherapy with ENHERTU in the experimental arm and evaluates whether combining ENHERTU with standard immunotherapy can improve outcomes for patients who typically have lower benefit from immunotherapy alone. The release notes there are currently no HER2 directed medicines approved in the first-line metastatic NSCLC setting.
AstraZeneca (NYSE:AZN) and Daiichi Sankyo announced Phase III TROPION-Breast02 results showing DATROWAY (datopotamab deruxtecan-dlnk) improved median overall survival by 5.0 months versus investigator’s choice chemotherapy (23.7 vs 18.7 months; HR 0.79; 95% CI 0.64-0.98; p=0.0291) in 1st-line metastatic triple-negative breast cancer patients not eligible for immunotherapy. DATROWAY also reduced risk of progression or death by 43% (PFS HR 0.57; median PFS 10.8 vs 5.6 months; p<0.0001) and showed higher confirmed response rates (62.5% vs 29.3%). Safety signals included Grade ≥3 TRAEs (33% vs 29%) and one drug-related Grade 5 ILD adjudicated in the DATROWAY arm.
AstraZeneca (AZN) and Daiichi Sankyo reported positive TROPION-Breast02 phase 3 results: DATROWAY (datopotamab deruxtecan) improved median overall survival by 5.0 months versus investigator's choice chemotherapy (23.7 vs 18.7 months; HR=0.79; 95% CI: 0.64-0.98; p=0.0291) in first-line metastatic triple negative breast cancer patients for whom immunotherapy was not an option.
DATROWAY also cut risk of progression or death by 43% (PFS HR=0.57; p<0.0001), showed higher ORR (62.5% vs 29.3%), longer median DoR (12.3 vs 7.1 months), and had comparable rates of grade ≥3 TRAEs (33% vs 29%); one drug-related adjudicated grade 5 ILD occurred.
AstraZeneca (AZN) and Daiichi Sankyo reported positive DESTINY-Breast05 Phase III results on October 18, 2025 showing ENHERTU reduced risk of invasive disease recurrence or death by 53% versus T-DM1 (HR 0.47; 95% CI 0.34-0.66; p<0.0001).
At three years, IDFS was 92.4% with ENHERTU vs 83.7% with T-DM1. Results were consistent across prespecified subgroups. Key secondary endpoints (DFS, DRFI, BMFI) also favored ENHERTU. Overall survival was immature (2.9% maturity at cut-off 2 July 2025).
Safety aligned with known profile: Grade ≥3 AEs were similar (50.6% vs 51.9%); ILD rates were 9.6% with ENHERTU and 1.6% with T-DM1, mostly Grade 1–2.
AstraZeneca (AZN) and Daiichi Sankyo reported DESTINY-Breast05 Phase 3 results showing ENHERTU reduced the risk of invasive disease recurrence or death by 53% (HR=0.47; 95% CI 0.34–0.66; p<0.0001) versus T-DM1 as post-neoadjuvant therapy in high-risk HER2+ early breast cancer.
Three-year IDFS was 92.4% for ENHERTU vs 83.7% for T-DM1; three-year DRFI was 93.9% vs 86.1%. OS was immature (2.9% mature; HR=0.61). Safety was consistent with known profile: grade ≥3 TEAEs ~50.6% (ENHERTU) vs 51.9% (T-DM1); ILD occurred in 9.6% (ENHERTU) with two adjudicated grade 5 events (0.2%).
ENHERTU (AZN) showed a statistically significant improvement in neoadjuvant pathologic complete response (pCR) in DESTINY-Breast11: 67.3% vs 56.3% with ddAC-THP (Δ11.2%; 95% CI 4.0-18.3; p=0.003).
ENHERTU followed by THP also produced higher RCB (0+I) rates (81.3% vs 69.1%) and consistent pCR gains across HR+ and HR– subgroups. Safety was described as favorable versus ddAC-THP with lower rates of grade ≥3 TEAEs (37.5% vs 55.8%), serious AEs (10.6% vs 20.2%), treatment interruptions (37.8% vs 54.5%) and left ventricular dysfunction (1.3% vs 6.1%).
Event-free survival was immature (4.5% maturity) with an early trend favoring ENHERTU (HR=0.56). The ENHERTU monotherapy arm was closed early; a supplemental BLA for ENHERTU followed by THP is under FDA review.
AstraZeneca (NYSE:AZN) and Daiichi Sankyo reported DESTINY-Breast11 Phase III results showing neoadjuvant ENHERTU (fam-trastuzumab deruxtecan-nxki) followed by THP produced a pCR rate of 67.3% vs 56.3% with a ΔpCR of +11.2% (95% CI 4.0–18.3), p=0.003. Improvements were seen in HR-positive (61.4% vs 52.3%) and HR-negative (83.1% vs 67.1%) subgroups.
Resection outcomes showed RCB 0+I 81.3% vs 69.1%. Safety favored ENHERTU with lower Grade ≥3 AEs (37.5% vs 55.8%), serious AEs (10.6% vs 20.2%) and left ventricular dysfunction (1.3% vs 6.1%). EFS was immature (4.5% maturity) with an early HR 0.56 (95% CI 0.26–1.17). A supplemental BLA is under FDA review.
AstraZeneca (NYSE:AZN) announced on October 17, 2025 that TEZSPIRE (tezepelumab‑ekko) received FDA approval for add‑on maintenance treatment of adults and pediatric patients aged 12+ with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP).
Approval was based on the Phase III WAYPOINT trial showing statistically significant reductions in nasal polyp severity, near‑elimination of the need for surgery and reduced systemic corticosteroid use versus placebo. TEZSPIRE is the first biologic targeting TSLP approved for CRSwNP. Regulatory applications are under review in the EU, China, Japan and other countries.
AstraZeneca (AZN) and Daiichi Sankyo reported initial results from a TROPION-PanTumor03 sub-study showing DATROWAY (datopotamab deruxtecan) plus rilvegostomig produced a confirmed objective response rate (ORR) of 68.2% (95% CI: 45.1–86.1) and disease control rate (DCR) of 95.5% (80% CI: 83.4–99.5) in cisplatin-ineligible first-line metastatic urothelial cancer (n=22).
In the second-line, previously platinum-treated/immunotherapy-naïve cohort (n=18), ORR was 38.9% (95% CI: 17.3–64.3) and median progression-free survival (PFS) was 12.5 months (95% CI: 4.2–NR). Median duration of response was not reached in either cohort. Safety was consistent with known profiles: grade ≥3 treatment-related adverse events occurred in 18.2% (first-line) and 38.9% (second-line); adjudicated ILD events were 1 (4.5%) and 2 (11.1%), respectively.