Astrazeneca Plc Stock Price, News & Analysis

AstraZeneca (AZN) will present its largest-ever hematology program at the 67th ASH Annual Meeting, December 6–9, 2025, with 65 abstracts across eight approved and investigational medicines and 15 oral presentations. Key highlights include a three-year follow-up Phase I study of surovatamig (CD19xCD3 T-cell engager) in relapsed/refractory follicular lymphoma, initial DURGA-1 data for AZD0120 (BCMAxCD19 CAR T) in relapsed/refractory multiple myeloma, 50-month ECHO results for CALQUENCE in first-line mantle cell lymphoma, and Phase III pediatric data for ULTOMIRIS in HSCT-associated thrombotic microangiopathy. Additional abstracts cover safety, subgroup analyses, real-world evidence, and other investigational assets.

AstraZeneca (NYSE:AZN) announced the US FDA has accepted the New Drug Application for baxdrostat under Priority Review for adults with hard-to-control hypertension, with a PDUFA target in Q2 2026. The NDA is based on the BaxHTN Phase III trial (n=796) that met primary and all secondary endpoints, showing placebo-adjusted seated systolic BP reductions of 9.8 mmHg (2 mg) and 8.7 mmHg (1 mg) at week 12. Baxdrostat was generally well tolerated and is being studied across a program of >20,000 patients for hypertension, primary aldosteronism, CKD and heart failure combinations.

Vistagen (Nasdaq: VTGN) appointed Nick Tressler as Chief Financial Officer effective December 1, 2025. Mr. Tressler has over 20 years of life‑science financial leadership, most recently serving as CFO of DYNEX Technologies and previously at American Gene Technologies and Senseonics (Nasdaq: SENS). He held senior roles at Sucampo (acquired 2018) and MedImmune (acquired 2007) and holds an MBA from Johns Hopkins.

The Compensation Committee granted an inducement incentive option for 150,000 shares with an exercise price equal to the December 1, 2025 closing price; vesting is 25% after one year, then monthly ratable vesting over 36 months.

AstraZeneca (NYSE:AZN) announced US FDA approval of IMFINZI (durvalumab) plus FLOT chemotherapy as the first and only perioperative immunotherapy for resectable early-stage and locally advanced (Stages II, III, IVA) gastric and gastroesophageal junction cancer.

Approval is based on MATTERHORN Phase III results showing a 29% reduction in risk of progression, recurrence or death (EFS HR 0.71; P<0.001) and a 22% reduction in risk of death (OS HR 0.78; P=0.021). Estimated three-year survival was 69% vs 62%. Safety was consistent with known profiles; Grade≥3 AEs were similar between arms (~71%).

AstraZeneca (AZN) will invest $2 billion to expand biologics manufacturing in Frederick, Maryland, and build a new clinical manufacturing facility in Gaithersburg, with both sites expected to be operational by 2029.

The plan nearly doubles commercial biologics capacity, onshores production for the rare disease portfolio, supports 2,600 jobs across both sites (including ~1,900 construction roles), and leverages AI, automation and high environmental standards. This is part of AstraZeneca's historic $50 billion US manufacturing and R&D commitment.

AstraZeneca (NYSE:AZN) reported positive Bax24 Phase III results on November 9, 2025: baxdrostat 2 mg produced a placebo-adjusted -14.0 mmHg reduction in 24‑hour ambulatory systolic blood pressure at 12 weeks (95% CI -17.2, -10.8; p<0.0001).

Key secondary results included a -13.9 mmHg night‑time SBP reduction and a -10.3 mmHg seated SBP reduction versus placebo; 71% of baxdrostat patients achieved ambulatory 24‑hour SBP <130 mmHg versus 17% on placebo (odds ratio 15.2; p<0.0001). Safety was reported as generally well tolerated and consistent with prior BaxHTN data. Full results were presented at AHA Scientific Sessions 2025 and will be shared with regulators.

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.