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 develops and commercializes prescription medicines across oncology, rare diseases, and BioPharmaceuticals, including cardiovascular, renal and metabolism, respiratory, and immunology. News about AZN commonly covers clinical-trial results, FDA and advisory-committee actions, product approvals, and updates to marketed medicines such as TRUQAP, BREZTRI, SAPHNELO, IMFINZI, IMJUDO, and ULTOMIRIS.
Company updates also address quarterly revenue and earnings trends, alliance and collaboration revenue, licensing transactions for pipeline assets, and governance changes. Recurring development themes include targeted oncology, COPD, asthma, systemic lupus erythematosus, liver cancer, prostate cancer, and rare or immune-mediated diseases.
AstraZeneca (AZN) reported positive interim Phase III DeLLphi-305 results for IMFINZI (durvalumab) plus tarlatamab in 1st-line extensive-stage small cell lung cancer (ES-SCLC).
The combination, used as maintenance after induction with IMFINZI plus platinum chemotherapy and etoposide, delivered a statistically significant and highly clinically meaningful improvement in overall survival versus IMFINZI alone, meeting the trial’s primary endpoint. Key secondary endpoints of progression-free survival and objective response rate were also improved with statistical significance. The regimen is described as the first and only immunotherapy combined with a bispecific T‑cell engager to show a survival benefit in this setting. The safety and tolerability profile of IMFINZI plus tarlatamab was consistent with the known profiles of the individual agents, with no new safety signals reported. Full data will be presented at a future medical meeting and shared with regulators.
AstraZeneca (AZN) reported full Phase III results from the OBERON and TITANIA trials showing tozorakimab 300mg every four weeks significantly reduced moderate and severe COPD exacerbations versus placebo on top of inhaled standard of care.
In former smokers, exacerbations fell by 29% in OBERON and 34% in TITANIA; in the overall population of current and former smokers, reductions were 30% and 29%, respectively. A pooled analysis showed clinically meaningful reductions across all prespecified blood eosinophil count (BEC) subgroups, including 23% reduction for BEC <150 cells/µL, 34% for ≥150, and 43% for ≥300. Tozorakimab was generally well tolerated; the only reported adverse drug reaction was injection-site reaction. The Biologics License Application for tozorakimab in COPD has been accepted for Priority Review by the US FDA, with an anticipated PDUFA date in Q1 2027, and the drug is also under review in the EU, China and other major markets.
AstraZeneca (AZN) received US FDA accelerated approval for ETCAMAH (camizestrant) plus a CDK4/6 inhibitor as 1st-line treatment for adult patients with HR‑positive, HER2‑negative, locally advanced or metastatic breast cancer with an emergent ESR1 mutation detected during aromatase inhibitor and CDK4/6 inhibitor therapy.
The decision is based on Phase III SERENA‑6, where ETCAMAH plus a CDK4/6 inhibitor reduced risk of disease progression or death by 56% versus an aromatase inhibitor plus CDK4/6 inhibitor (HR 0.44; median PFS 16.0 vs 9.2 months; p<0.00001). A pre‑planned analysis showed PFS2 of 25.7 vs 19.1 months (HR 0.63; p=0.00373) and overall survival data trending in favour of the ETCAMAH combination (HR 0.87) but still maturing.
The FDA simultaneously approved a companion ctDNA test to detect emerging ESR1 mutations and guide early therapy switch. Safety in SERENA‑6 was consistent with known profiles, though warnings highlight QTc prolongation, bradycardia, embryo‑fetal toxicity, common hematologic lab abnormalities and visual disturbances.
AstraZeneca (NASDAQ: AZN) has completed its previously announced exclusive global license agreement with Dizal Pharmaceutical for ZEGFROVY (sunvozertinib), an oral irreversible EGFR inhibitor for lung cancer, securing worldwide rights to develop and commercialize the medicine.
ZEGFROVY is approved in the US and China for 2nd-line treatment of adult patients with locally advanced or metastatic NSCLC harboring EGFR exon 20 insertion mutations after progression on platinum-based chemotherapy. AstraZeneca plans a US launch in 4Q 2026. A supplemental NDA for 1st-line NSCLC has been accepted by the US FDA and submitted in China, supported by positive Phase III WU-KONG28 data, and the drug has Breakthrough Therapy Designation in both markets. Financial terms include a $600m upfront payment, up to $900m in milestones, and tiered royalties to Dizal, with no change to AstraZeneca’s 2026 financial guidance.
AstraZeneca (AZN) and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) plus pertuzumab has been approved in the EU as first-line treatment for adults with unresectable or metastatic HER2 positive breast cancer. The European Commission decision is based on phase 3 DESTINY-Breast09 data.
In 383 previously untreated HER2 positive metastatic patients, Enhertu plus pertuzumab reduced the risk of disease progression or death by 44% versus taxane, trastuzumab and pertuzumab (THP) (hazard ratio 0.56; 95% CI 0.44–0.71). Median progression-free survival reached 40.7 months versus 26.9 months with THP, and confirmed objective response rates were 85.1% versus 78.6%. Safety was consistent with known profiles, though grade 3/4 neutropenia occurred in 24.8% and grade 5 events in 1.6% of patients.
Following this EU approval, AstraZeneca will pay Daiichi Sankyo a $100 million milestone, and Enhertu plus pertuzumab is now approved as first-line HER2 positive metastatic breast cancer therapy in more than 40 countries/regions.
AstraZeneca (LSE/STO/NYSE: AZN) reported positive high-level Phase III results from the randomized, double-blind CROSSING trial of TEZSPIRE (tezepelumab-ekko) in 368 patients aged 12-80 with eosinophilic esophagitis (EoE). TEZSPIRE, given subcutaneously every four weeks, achieved statistically significant and clinically meaningful improvements versus placebo in both co-primary endpoints—histologic remission and dysphagia symptoms (DSQ score)—at Week 24, sustained through Week 52 for both tested doses.
According to AstraZeneca, all key secondary endpoints, including longer-term histologic, endoscopic and inflammatory measures, were also met, and the safety profile was generally consistent with existing approved indications. TEZSPIRE, a first-in-class TSLP inhibitor already approved in severe asthma and CRSwNP, is being co-developed and co-commercialized globally with Amgen.
Daiichi Sankyo (TSE:4568) and AstraZeneca (LSE/STO/NYSE:AZN) have dosed the first patient in the global phase 3 TROPION-Urothelial04 trial. The study evaluates Datroway (datopotamab deruxtecan) plus rilvegostomig or Datroway monotherapy versus standard adjuvant options (durvalumab, nivolumab, or enfortumab vedotin plus pembrolizumab) in high-risk muscle invasive urothelial cancer (MIUC) after surgery.
The open-label, three-arm trial will randomize about 915 patients worldwide. The primary endpoint is investigator-assessed disease-free survival for Datroway plus rilvegostomig versus standard of care; key secondary endpoints include overall survival, multiple recurrence-free measures, patient-reported outcomes and safety. According to Daiichi Sankyo, the TIGIT component of rilvegostomig is derived from Compugen’s (Nasdaq/TASE:CGEN) clinical-stage antibody COM902.
Datroway, a TROP2-directed DXd antibody-drug conjugate, is already approved at 6 mg/kg in numerous countries for specific advanced breast cancer and EGFR-mutated NSCLC indications, and is being studied in more than 20 trials across lung, breast and urothelial cancers.
AstraZeneca (NASDAQ:AZN) and Daiichi Sankyo reported that Phase III DESTINY-Lung04 met its primary endpoint, with ENHERTU (fam-trastuzumab deruxtecan-nxki) showing a statistically significant and clinically meaningful improvement in progression-free survival (PFS) versus global standard 1st-line therapy (platinum-pemetrexed plus pembrolizumab) in unresectable, locally advanced or metastatic HER2‑mutant non-squamous NSCLC.
The trial will continue to assess overall survival and other secondary endpoints. According to AstraZeneca, the ENHERTU safety profile in DESTINY-Lung04 was generally consistent with its known risks, including interstitial lung disease/pneumonitis, neutropenia, left ventricular dysfunction, and embryo‑fetal toxicity, for which detailed boxed warnings and management guidelines are provided.
AstraZeneca (AZN) reported positive high-level results from the global Phase III SAFFRON trial evaluating TAGRISSO (osimertinib) plus savolitinib versus doublet platinum-based chemotherapy in 338 patients with EGFR‑mutated, locally advanced or metastatic NSCLC whose tumors had high MET overexpression or amplification and had progressed on prior TAGRISSO.
The combination demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (primary endpoint) and overall survival versus chemotherapy. The safety profile was consistent with known profiles of each medicine, with no new safety findings. Data will be presented at a future medical meeting and shared with global regulators. TAGRISSO plus savolitinib is already approved in China in a related post‑EGFR‑TKI setting based on the SACHI Phase III trial.
AstraZeneca (AZN) and Daiichi Sankyo reported positive topline results from the phase 3 DESTINY-Lung04 trial, where Enhertu (trastuzumab deruxtecan) showed a statistically significant and clinically meaningful improvement in progression-free survival (PFS) versus global standard of care (platinum-pemetrexed chemotherapy plus pembrolizumab) as first-line treatment for unresectable, locally advanced or metastatic HER2 mutant non-squamous NSCLC.
The global, randomized trial enrolled 454 patients and will continue to assess secondary endpoints including overall survival. According to the companies, Enhertu’s safety profile in DESTINY-Lung04 was generally consistent with its known profile, with no new safety concerns identified. Data will be presented at an upcoming medical meeting and shared with global regulatory authorities. Enhertu is already approved in numerous countries for previously treated HER2 mutant metastatic NSCLC and multiple HER2-driven tumors.