AstraZeneca Stock Price, News & Analysis

AstraZeneca (NYSE:AZN) announced that IMFINZI® (durvalumab) has received Priority Review and Breakthrough Therapy Designation from the FDA for treating resectable early-stage gastric and gastroesophageal junction (GEJ) cancers. The regulatory decision is expected in Q4 2025.

The application is supported by the MATTERHORN Phase III trial results, which demonstrated a 29% reduction in the risk of disease progression, recurrence, or death versus chemotherapy alone. The trial showed 78.2% of IMFINZI-treated patients were event-free at one year, compared to 74.0% in the control group, with estimated 24-month rates of 67.4% versus 58.5%.

If approved, IMFINZI would become the first and only perioperative immunotherapy-based regimen for this indication, potentially transforming care for patients with early gastric and GEJ cancers.

AstraZeneca (NASDAQ:AZN) has announced a landmark $50 billion investment in the United States by 2030, aiming to strengthen America's pharmaceutical manufacturing and R&D capabilities. The centerpiece is a new multi-billion dollar drug substance manufacturing facility in Virginia, representing AstraZeneca's largest single manufacturing investment globally.

The investment includes expansion of R&D facilities in Maryland, a new R&D center in Massachusetts, cell therapy facilities in Maryland and California, and manufacturing expansions in Indiana and Texas. This strategic move supports AstraZeneca's goal to achieve $80 billion in total revenue by 2030, with 50% expected to be generated in the US. The initiative is projected to create tens of thousands of new jobs and will focus on producing innovative medicines, including weight management and metabolic treatments.

AstraZeneca (NYSE:AZN) announced positive final overall survival (OS) results from the FLAURA2 Phase III trial for TAGRISSO® (osimertinib) combined with chemotherapy in treating 1st-line locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC).

The combination demonstrated a statistically significant and clinically meaningful improvement in overall survival compared to TAGRISSO monotherapy. The safety profile remained manageable with longer follow-up, though adverse event rates were higher in the combination arm due to chemotherapy-related effects.

TAGRISSO plus chemotherapy is currently approved in over 80 countries, including the US, EU, China, and Japan. The treatment has been used in more than one million patients worldwide across its indications.

AstraZeneca (NASDAQ:AZN) and Daiichi Sankyo announced that ENHERTU® in combination with pertuzumab has received Breakthrough Therapy Designation (BTD) from the FDA for first-line treatment of HER2 positive metastatic breast cancer.

The designation is based on data from the DESTINY-Breast09 phase 3 trial, which demonstrated a remarkable median progression-free survival of more than three years when using ENHERTU plus pertuzumab. This represents a significant improvement over the current standard of care that has been used for over a decade.

This marks ENHERTU's ninth BTD overall and fifth BTD for metastatic breast cancer, highlighting the drug's expanding potential in cancer treatment. It is also Daiichi Sankyo's thirteenth BTD across its oncology portfolio.

AstraZeneca (NYSE:AZN) announced positive Phase III trial results for baxdrostat, a potential first-in-class aldosterone synthase inhibitor for treating uncontrolled or treatment-resistant hypertension. The BaxHTN trial, involving 796 patients, demonstrated that both 2mg and 1mg doses achieved statistically significant and clinically meaningful reductions in systolic blood pressure compared to placebo at 12 weeks.

The trial successfully met its primary endpoint and all secondary endpoints, with baxdrostat showing a favorable safety profile. This breakthrough is particularly significant as 50% of US hypertensive patients on multiple treatments still struggle with blood pressure control, and globally, 1.3 billion people live with hypertension.

AstraZeneca (NYSE:AZN) has received US FDA approval for DATROWAY® (datopotamab deruxtecan-dlnk) to treat adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy.

The approval, granted under accelerated approval based on objective response rate (ORR) of 45% and duration of response (DoR) of 6.5 months, follows Priority Review and Breakthrough Therapy Designation. DATROWAY becomes the first and only TROP2-directed therapy approved in the US for lung cancer treatment.

The safety profile was evaluated in 125 patients across multiple trials, with no new safety concerns identified. A milestone payment of $45 million is due from AstraZeneca to Daiichi Sankyo following this approval.

AstraZeneca (NYSE:AZN) and Daiichi Sankyo have received FDA approval for DATROWAY® (datopotamab deruxtecan-dlnk), marking it as the first TROP2 directed therapy for previously treated advanced EGFR-mutated non-small cell lung cancer (NSCLC). The approval is based on the TROPION-Lung05 phase 2 and TROPION-Lung01 phase 3 trials, where DATROWAY showed a 45% objective response rate with a median duration of response of 6.5 months.

The drug received Priority Review and Breakthrough Therapy Designation from the FDA. Following this approval, AstraZeneca will pay a $45 million milestone payment to Daiichi Sankyo. This marks DATROWAY's second U.S. approval in less than six months, with Daiichi Sankyo recognizing U.S. sales.

AstraZeneca and Daiichi Sankyo have initiated the DESTINY-Endometrial01 phase 3 trial for ENHERTU in first-line treatment of HER2 expressing primary advanced or recurrent endometrial cancer. The study will evaluate ENHERTU combined with rilvegostomig or pembrolizumab versus standard platinum-based chemotherapy with pembrolizumab. The trial targets patients with HER2 expressing (IHC 3+/2+), mismatch repair proficient endometrial cancer, a condition affecting 18-56% of cases with a median survival of up to 30 months in advanced stages. This initiative follows positive results from the DESTINY-PanTumor02 study, which led to tumor agnostic approval for ENHERTU in previously treated HER2 positive metastatic tumors. The trial represents a significant step in addressing the unmet need in endometrial cancer treatment, where no HER2 directed medicines are currently approved for first-line therapy.

AstraZeneca and Daiichi Sankyo reported positive Phase III DESTINY-Breast09 trial results for ENHERTU plus pertuzumab as first-line treatment for HER2-positive metastatic breast cancer. The combination demonstrated a 44% reduction in disease progression or death risk versus standard THP therapy, with median progression-free survival of 40.7 months compared to 26.9 months. The objective response rate was 85.1% for ENHERTU plus pertuzumab versus 78.6% for THP, with 58 complete responses versus 33. The treatment showed consistent benefits across subgroups, with duration of response exceeding three years. Safety profile aligned with known profiles, with 12.1% of patients experiencing interstitial lung disease/pneumonitis, mostly low-grade. This marks the first significant improvement in first-line treatment outcomes for HER2-positive metastatic breast cancer in over a decade.