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) and Daiichi Sankyo’s Enhertu has received a positive CHMP opinion in the EU as adjuvant monotherapy for adults with resected HER2 positive breast cancer who have residual invasive disease after neoadjuvant taxane-based and HER2 targeted therapy.
The recommendation is based on phase 3 DESTINY-Breast05, where Enhertu reduced the risk of invasive disease recurrence or death (IDFS) by 53% versus T-DM1 (HR=0.47; 95% CI: 0.34-0.66; p<0.0001). Three-year IDFS was 92.4% with Enhertu versus 83.7% with T-DM1. Disease-free survival was also improved, with a 53% risk reduction and three-year DFS of 92.3% vs 83.5%. The safety profile was consistent with prior experience; ILD/pneumonitis occurred in 9.6% of patients (mostly low grade), including 0.2% grade 5 events. The CHMP opinion now goes to the European Commission for final marketing authorization decision.
AstraZeneca (AZN) reported that ENHERTU (fam-trastuzumab deruxtecan-nxki) significantly improved progression-free survival versus pembrolizumab plus platinum-pemetrexed chemotherapy as 1st-line therapy for unresectable, locally advanced or metastatic HER2-mutant non-squamous NSCLC in the Phase III DESTINY-Lung04 trial.
ENHERTU monotherapy reduced the risk of disease progression or death by 37.0% (HR 0.63; 95% CI 0.50-0.79; p<0.0001), with median PFS of 14.3 months versus 8.3 months for pembrolizumab plus chemotherapy (BICR). Objective response rate was 70.0% (159/227) for ENHERTU versus 44.5% (101/227) for the control arm, and median duration of response was 13.4 vs 9.7 months. Median PFS2 was 22.7 vs 17.3 months (HR 0.80; 95% CI 0.62-1.02).
Median overall survival was 29.3 months with ENHERTU and 33.1 months with pembrolizumab plus chemotherapy (HR 1.15; 95% CI 0.88-1.52), with OS data 46.9% mature and not formally tested. Grade ≥3 treatment-related adverse events were similar (34.1% vs 33.6%), but ILD/pneumonitis occurred in 20.8% of ENHERTU-treated patients, including Grade 5 events.
AstraZeneca (AZN) reported eight-year overall survival data from the Phase III ADAURA trial showing sustained benefit of TAGRISSO (osimertinib) versus placebo in early-stage EGFR‑mutated NSCLC after complete tumor resection.
In the primary population (stages II‑IIIA), TAGRISSO reduced the risk of death by 47% versus placebo (HR 0.53; 95% CI 0.38‑0.75), with an estimated 74% of patients alive at 96 months compared to 58% on placebo. In the overall population (stages IB‑IIIA), the risk of death was reduced by 48% (HR 0.52; 95% CI 0.39‑0.71), with 79% versus 64% alive at eight years. Median follow‑up reached 92 and 93.3 months for TAGRISSO in the primary and overall populations, respectively. Final ADAURA safety remained consistent with the established profile, while extensive safety information highlights key risks including ILD/pneumonitis, QTc prolongation, cardiomyopathy, ocular and severe cutaneous reactions, and aplastic anemia.
AstraZeneca (AZN) and Daiichi Sankyo reported that Enhertu (trastuzumab deruxtecan) achieved a median progression‑free survival (PFS) of 14.3 months as first‑line therapy for patients with unresectable, locally advanced or metastatic HER2 mutant non‑squamous non‑small cell lung cancer in the phase 3 DESTINY‑Lung04 trial, versus 8.3 months with pembrolizumab plus platinum‑pemetrexed chemotherapy (HR=0.63; p<0.0001).
Enhertu reduced the risk of disease progression or death by 37.0% and showed an objective response rate of 70.0% compared with 44.5% for the control arm. Median duration of response was 13.4 months with Enhertu versus 9.7 months, and median PFS2 was 22.7 months versus 17.3 months. Overall survival data were 46.9% mature; median OS was 29.3 months with Enhertu and 33.1 months with pembrolizumab plus chemotherapy (HR=1.15), with no observed OS benefit at this interim analysis.
Grade ≥3 treatment‑related adverse events occurred in 34.1% of Enhertu patients. Interstitial lung disease or pneumonitis was seen in 20.8% of patients, including 1.8% grade 5 events.
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.