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 (LSE/STO/NYSE: AZN) and Daiichi Sankyo received European Commission approval for Enhertu as the first tumor-agnostic HER2-directed antibody drug conjugate. The monotherapy is indicated for adults with unresectable or metastatic HER2 positive (IHC 3+) solid tumors after prior treatment and without satisfactory options.
Approval is based on three phase 2 trials (DESTINY-PanTumor02, -Lung01, -CRC02), showing confirmed ORRs of 52.3%, 52.9% and 46.9% and median DORs up to 21.1 months. A $25 million milestone payment is due from AstraZeneca to Daiichi Sankyo.
AstraZeneca (NASDAQ:AZN) and Daiichi Sankyo’s Datroway (datopotamab deruxtecan) received a positive CHMP opinion in the EU as first-line monotherapy for unresectable or metastatic triple negative breast cancer patients not eligible for PD-1/PD-L1 inhibitors.
TROPION-Breast02 showed 5.0-month median overall survival gain (23.7 vs 18.7 months; HR=0.79) and longer progression-free survival (10.8 vs 5.6 months; HR=0.57) versus chemotherapy, plus higher objective response rate (62.5% vs 29.3%). Datroway is already approved in the US and under review in several other regions.
AstraZeneca (NYSE:AZN) and YMCA of the USA announced a five-year, multimillion-dollar partnership to strengthen community-based cancer education and survivorship support across the US.
The initiative aims to reach 175,000 people in 75 communities in its first two years, focusing on screening, early detection, and evidence-based programs for cancer survivors.
AstraZeneca (NASDAQ:AZN) announced US FDA approval of TRUQAP (capivasertib) plus abiraterone and prednisone for adult patients with PTEN-deficient metastatic androgen pathway modulation-naïve or sensitive (mAPMN/S) prostate cancer, detected by an FDA‑authorized test.
In Phase III CAPItello‑281, the combination reduced risk of radiographic progression or death by 19% (HR 0.81; 95% CI 0.66–0.98; p=0.034) and improved median rPFS to 33.2 vs 25.7 months. Overall survival data are immature but numerically favor the TRUQAP regimen. A companion PTEN diagnostic was approved alongside the indication.
Common Grade ≥3 adverse events with the prostate regimen included rash (12.3%) and hyperglycemia (10.3%), and 20% of patients discontinued TRUQAP due to adverse reactions.
AstraZeneca (AZN) reported updated Phase III SERENA-6 results in HR-positive, HER2-negative advanced breast cancer with emergent ESR1 mutation. Switching to camizestrant + CDK4/6 inhibitor reduced first progression or death by 55% (PFS 16.8 vs 9.2 months) and second progression or death by 37% (PFS2 25.7 vs 19.1 months) versus aromatase inhibitor combinations.
Median total ctDNA changed −99% with camizestrant versus +64% with standard care; 51% achieved ctDNA clearance vs 1.9%. Chemotherapy/ADC-free survival was 22.6 vs 18.7 months. Safety was consistent with known profiles. Camizestrant is approved in UAE and Saudi Arabia, with EU, US, Japan and other reviews ongoing.
AstraZeneca (AZN)/b) reported EMERALD-3 Phase III data in embolization-eligible unresectable hepatocellular carcinoma. IMFINZI (durvalumab) plus IMJUDO (tremelimumab-actl), lenvatinib and TACE cut the risk of progression or death by versus TACE alone (PFS HR 0.70; median PFS 13.0 vs 9.8 months).
The STRIDE plus TACE arm also showed clinically meaningful PFS and OS improvements versus TACE, with median PFS 12.9 vs 8.1 months. Grade ≥3 adverse events occurred in 71.4% and 64% of patients in the investigational arms, compared with 28.6% for TACE alone.
AstraZeneca (AZN) received US FDA approval for IMFINZI (durvalumab) plus BCG as the first immunotherapy combination for BCG-naïve, high-risk non-muscle-invasive bladder cancer (NMIBC).
According to AstraZeneca, Phase III POTOMAC data showed a 32% reduction in risk of high-risk disease recurrence, progression or death versus BCG alone and no new safety signals.
AstraZeneca (NASDAQ:AZN) and Daiichi Sankyo’s DATROWAY (datopotamab deruxtecan-dlnk) received US FDA approval for 1st-line treatment of adults with unresectable or metastatic triple-negative breast cancer (TNBC) who are not PD-1/PD-L1 inhibitor candidates.
In Phase III TROPION-Breast02, DATROWAY improved median overall survival by 5.0 months vs chemotherapy (HR 0.79) and reduced risk of progression or death by 43% (HR 0.57), with an ORR of 64% vs 30%. It is included in NCCN Guidelines as a Category 1 Preferred 1st-line option. Key risks include ILD/pneumonitis, ocular events, stomatitis and embryo-fetal toxicity.
AstraZeneca (NYSE:AZN) and Daiichi Sankyo’s Datroway (datopotamab deruxtecan) received U.S. FDA approval for first-line treatment of adults with unresectable or metastatic triple negative breast cancer (TNBC) who are not PD-1/PD-L1 inhibitor candidates.
Approval is based on phase 3 TROPION-Breast02, where Datroway improved median overall survival to 23.7 vs 18.7 months, progression-free survival to 10.8 vs 5.6 months, and objective response rate to 64% vs 30% versus chemotherapy, and is now a Category 1 Preferred option in NCCN Guidelines.
AstraZeneca (AZN) and Daiichi Sankyo announced that Enhertu received a positive CHMP opinion in the EU as monotherapy for adults with previously treated unresectable or metastatic HER2 positive (IHC 3+) solid tumors lacking satisfactory options.
The recommendation, based on phase 2 DESTINY-PanTumor02, DESTINY-Lung01 and DESTINY-CRC02, showed confirmed ORRs of 51.4%, 52.9% and 46.9% respectively, with median DOR up to 14.2 months. The European Commission will now review the opinion.