Astrazeneca Plc Stock Price, News & Analysis

AstraZeneca (NYSE:AZN) reported positive Phase III NATRON results for FASENRA (benralizumab) in hypereosinophilic syndrome (HES) on 7 November 2025. The trial met its primary endpoint: FASENRA delayed time to first HES worsening/flare and reduced risk by 65% versus placebo (19.4% vs 42.4%; HR 0.35; P=0.0024). Key secondaries were met: 66% lower annualized flare rate (0.41 vs 1.23; P=0.0008) and delayed hematologic relapse (HR 0.08; P<0.0001). PROMIS Fatigue improved by a LS mean difference of -4.72 at Week 24 (P=0.0017). Data will be presented at ACAAI 2025 and ASH 2025; company said it is progressing a regulatory filing.

AstraZeneca (NYSE:AZN) reported 9M 2025 Total Revenue of $43,236m, up 11% CER, driven by Product Revenue of $43,143m. Core EPS rose 15% to $7.04 and Reported EPS was $5.10. Oncology revenue grew 16% and R&I grew 13%. The company announced 16 positive Phase III readouts and 31 approvals in major regions year-to-date. Guidance for FY 2025 at CER was reiterated: Total Revenue expected to increase by a high single-digit percentage and Core EPS by a low double-digit percentage. Corporate updates include a harmonised global listing effective 2 Feb 2026 and a $4.5bn Virginia plant as part of a $50bn US investment plan to 2030.

AstraZeneca (AZN) and Daiichi Sankyo announced that the first patient has been dosed in DESTINY-Lung06, a Phase 3 trial testing ENHERTU (trastuzumab deruxtecan) plus pembrolizumab versus pembrolizumab with platinum-based chemotherapy and pemetrexed as first-line treatment for unresectable, locally advanced or metastatic HER2 overexpressing, non-squamous NSCLC with PD-L1 TPS <50%.

The trial replaces traditional chemotherapy with ENHERTU in the experimental arm and evaluates whether combining ENHERTU with standard immunotherapy can improve outcomes for patients who typically have lower benefit from immunotherapy alone. The release notes there are currently no HER2 directed medicines approved in the first-line metastatic NSCLC setting.

AstraZeneca (NYSE:AZN) and Daiichi Sankyo announced Phase III TROPION-Breast02 results showing DATROWAY (datopotamab deruxtecan-dlnk) improved median overall survival by 5.0 months versus investigator’s choice chemotherapy (23.7 vs 18.7 months; HR 0.79; 95% CI 0.64-0.98; p=0.0291) in 1st-line metastatic triple-negative breast cancer patients not eligible for immunotherapy. DATROWAY also reduced risk of progression or death by 43% (PFS HR 0.57; median PFS 10.8 vs 5.6 months; p<0.0001) and showed higher confirmed response rates (62.5% vs 29.3%). Safety signals included Grade ≥3 TRAEs (33% vs 29%) and one drug-related Grade 5 ILD adjudicated in the DATROWAY arm.

AstraZeneca (AZN) and Daiichi Sankyo reported positive TROPION-Breast02 phase 3 results: DATROWAY (datopotamab deruxtecan) improved median overall survival by 5.0 months versus investigator's choice chemotherapy (23.7 vs 18.7 months; HR=0.79; 95% CI: 0.64-0.98; p=0.0291) in first-line metastatic triple negative breast cancer patients for whom immunotherapy was not an option.

DATROWAY also cut risk of progression or death by 43% (PFS HR=0.57; p<0.0001), showed higher ORR (62.5% vs 29.3%), longer median DoR (12.3 vs 7.1 months), and had comparable rates of grade ≥3 TRAEs (33% vs 29%); one drug-related adjudicated grade 5 ILD occurred.

AstraZeneca (AZN) and Daiichi Sankyo reported positive DESTINY-Breast05 Phase III results on October 18, 2025 showing ENHERTU reduced risk of invasive disease recurrence or death by 53% versus T-DM1 (HR 0.47; 95% CI 0.34-0.66; p<0.0001).

At three years, IDFS was 92.4% with ENHERTU vs 83.7% with T-DM1. Results were consistent across prespecified subgroups. Key secondary endpoints (DFS, DRFI, BMFI) also favored ENHERTU. Overall survival was immature (2.9% maturity at cut-off 2 July 2025).

Safety aligned with known profile: Grade ≥3 AEs were similar (50.6% vs 51.9%); ILD rates were 9.6% with ENHERTU and 1.6% with T-DM1, mostly Grade 1–2.

AstraZeneca (AZN) and Daiichi Sankyo reported DESTINY-Breast05 Phase 3 results showing ENHERTU reduced the risk of invasive disease recurrence or death by 53% (HR=0.47; 95% CI 0.34–0.66; p<0.0001) versus T-DM1 as post-neoadjuvant therapy in high-risk HER2+ early breast cancer.

Three-year IDFS was 92.4% for ENHERTU vs 83.7% for T-DM1; three-year DRFI was 93.9% vs 86.1%. OS was immature (2.9% mature; HR=0.61). Safety was consistent with known profile: grade ≥3 TEAEs ~50.6% (ENHERTU) vs 51.9% (T-DM1); ILD occurred in 9.6% (ENHERTU) with two adjudicated grade 5 events (0.2%).

ENHERTU (AZN) showed a statistically significant improvement in neoadjuvant pathologic complete response (pCR) in DESTINY-Breast11: 67.3% vs 56.3% with ddAC-THP (Δ11.2%; 95% CI 4.0-18.3; p=0.003).

ENHERTU followed by THP also produced higher RCB (0+I) rates (81.3% vs 69.1%) and consistent pCR gains across HR+ and HR– subgroups. Safety was described as favorable versus ddAC-THP with lower rates of grade ≥3 TEAEs (37.5% vs 55.8%), serious AEs (10.6% vs 20.2%), treatment interruptions (37.8% vs 54.5%) and left ventricular dysfunction (1.3% vs 6.1%).

Event-free survival was immature (4.5% maturity) with an early trend favoring ENHERTU (HR=0.56). The ENHERTU monotherapy arm was closed early; a supplemental BLA for ENHERTU followed by THP is under FDA review.

AstraZeneca (NYSE:AZN) and Daiichi Sankyo reported DESTINY-Breast11 Phase III results showing neoadjuvant ENHERTU (fam-trastuzumab deruxtecan-nxki) followed by THP produced a pCR rate of 67.3% vs 56.3% with a ΔpCR of +11.2% (95% CI 4.0–18.3), p=0.003. Improvements were seen in HR-positive (61.4% vs 52.3%) and HR-negative (83.1% vs 67.1%) subgroups.

Resection outcomes showed RCB 0+I 81.3% vs 69.1%. Safety favored ENHERTU with lower Grade ≥3 AEs (37.5% vs 55.8%), serious AEs (10.6% vs 20.2%) and left ventricular dysfunction (1.3% vs 6.1%). EFS was immature (4.5% maturity) with an early HR 0.56 (95% CI 0.26–1.17). A supplemental BLA is under FDA review.