Astrazeneca Plc Stock Price, News & Analysis

AstraZeneca (AZN) and Daiichi Sankyo initiated TROPION-Lung17, a phase 3 trial testing DATROWAY (datopotamab deruxtecan) versus docetaxel in patients with previously treated, locally advanced or metastatic nonsquamous NSCLC that are TROP2 NMR positive. The trial prospectively enrolls patients using AstraZeneca’s Quantitative Continuous Scoring (QCS) TROP2 NMR biomarker; the investigational AI-powered companion diagnostic has received a Breakthrough Device Designation in the U.S. The first patient has been dosed, and TROPION-Lung17 is the ninth phase 3 study of DATROWAY in NSCLC.

AstraZeneca (NYSE:AZN) appointed Rick R. Suarez as Senior Vice President, US President and Head of the US BioPharmaceuticals Business Unit, effective immediately and based in Wilmington, Delaware. Suarez will lead execution of the company’s $50 billion US R&D and manufacturing investment, which includes a $4.5 billion manufacturing facility in Virginia — AstraZeneca’s largest single manufacturing investment. The investment supports a target of $80 billion total revenue by 2030, with roughly half expected from the US. Suarez returns from serving as Country President for Spain and brings more than 20 years of US healthcare experience across commercial, medical and market access roles.

AstraZeneca (NYSE:AZN) announced that ENHERTU (fam-trastuzumab deruxtecan-nxki) received Breakthrough Therapy Designation (BTD) in the US on December 22, 2025 for adult patients with HER2-positive early breast cancer with residual invasive disease after neoadjuvant treatment and high risk of recurrence.

The FDA decision was based on positive DESTINY-Breast05 Phase III results presented at ESMO 2025 and published in The New England Journal of Medicine. This marks ENHERTU's tenth BTD and targets the post-neoadjuvant setting to reduce invasive disease recurrence.

AstraZeneca (AZN) and collaborators have dosed the first patient in the DESTINY-Endometrial02 phase 3 trial testing ENHERTU® (trastuzumab deruxtecan) as adjuvant therapy versus standard chemotherapy, with or without radiotherapy, for patients with HER2 expressing (IHC 3+/2+) endometrial cancer.

The global trial is conducted with The GOG Foundation and ENGOT (lead group GINECO). ENHERTU is co‑developed with Daiichi Sankyo. The release notes HER2 expression in ~18%–56% of endometrial cancers and a 39%–56% 18‑month recurrence/death rate in high‑risk patients after standard adjuvant care. There are currently no approved HER2 directed adjuvant therapies for this indication.

ENHERTU (AstraZeneca: AZN) received U.S. Breakthrough Therapy Designation on December 22, 2025, for adult patients with HER2 positive early breast cancer with residual invasive disease after neoadjuvant therapy and high recurrence risk.

The FDA granted BTD based on the DESTINY-Breast05 phase 3 results presented at ESMO 2025 and published in The New England Journal of Medicine, which showed ENHERTU may reduce invasive disease recurrence versus the current standard of care. This is ENHERTU's tenth BTD and the sixteenth BTD across Daiichi Sankyo's oncology portfolio.

AstraZeneca (AZN) and Daiichi Sankyo announced the European Medicines Agency has validated a Type II Variation application for DATROWAY (datopotamab deruxtecan) as first-line monotherapy for adults with unresectable or metastatic triple negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitors.

The application, based on the pivotal TROPION-Breast02 phase 3 trial presented at ESMO 2025, showed statistically significant improvements in overall survival (OS) and progression-free survival (PFS) versus investigator's choice chemotherapy. Validation starts the EMA scientific review; additional global submissions are underway.

AstraZeneca (AZN) and Daiichi Sankyo announced US FDA approval (Dec 15, 2025) of ENHERTU (fam-trastuzumab deruxtecan-nxki) plus pertuzumab as a 1st-line treatment for adult patients with unresectable or metastatic HER2-positive breast cancer. Approval is based on DESTINY-Breast09 Phase III results showing a 44% reduced risk of progression or death (HR 0.56; 95% CI 0.44–0.71; p<0.0001) and a median PFS of 40.7 months vs 26.9 months for THP. Safety was consistent with known profiles. A $150m milestone payment from AstraZeneca to Daiichi Sankyo is due following US approval.

AstraZeneca (AZN) and Daiichi Sankyo announced U.S. FDA approval of ENHERTU plus pertuzumab as a first-line treatment for adult patients with unresectable or metastatic HER2 positive breast cancer, based on DESTINY-Breast09 phase 3 results.

The trial showed a 44% reduction in risk of progression or death (HR 0.56; 95% CI 0.44-0.71; p<0.0001), median PFS of 40.7 months vs 26.9 months for THP, ORR 87% vs 81%, and confirmed CR rates 15% vs 8%. Safety included Boxed WARNINGS for ILD/pneumonitis and embryo-fetal toxicity; serious adverse reactions occurred in 27% and fatalities in 3.4% of patients. A $150 million milestone from AstraZeneca to Daiichi Sankyo is payable following approval.

AstraZeneca (AZN) announced on December 9, 2025 that the first patient has been dosed in the randomized phase of the DESTINY-Ovarian01 phase 3 trial. The study is evaluating ENHERTU (trastuzumab deruxtecan) plus bevacizumab versus bevacizumab monotherapy as first-line maintenance after platinum-based chemotherapy with bevacizumab in patients with HER2 expressing (IHC 3+/2+/1+) advanced high-grade epithelial ovarian cancer.

The trial is conducted with ENGOT partners (GEICO lead), GOG-F, and APGOT. The announcement cites prior DESTINY-PanTumor02 ovarian cohort data showing clinically meaningful, durable responses in previously treated patients and notes HER2 expression in up to 55% of ovarian cancers, a 5-year survival of 31.8% for advanced disease, and 70–80% recurrence rates after standard treatment.