ASTRAZENECA PLC

AstraZeneca announced that its drug Truqap (capivasertib), in combination with abiraterone and prednisone, has received US FDA approval. This marks the first and only targeted treatment for adult patients with PTEN-deficient metastatic androgen pathway modulation-na ve or sensitive prostate cancer. The approval is based on positive results from the CAPItello-281 Phase III trial, which demonstrated a statistically significant 19% reduction in the risk of radiographic disease progression or death, and a clinically meaningful improvement in median rPFS of 7.5 months. This approval addresses an aggressive form of prostate cancer associated with poor prognosis, affecting approximately one in four patients with mAPMN/S prostate cancer.

AstraZeneca PLC announced the admission of 14,120 new ordinary shares of $0.25 each to trading on the Main Market of the London Stock Exchange. These shares were issued between May 1, 2026, and May 31, 2026, under the company's existing block admission for employee share schemes. Following this admission, the total number of ordinary shares in issue for AstraZeneca PLC is 1,551,009,750.

AstraZeneca PLC announced its total voting rights as of May 31, 2026. The company's issued share capital with voting rights stands at 1,551,009,750 ordinary shares of US$0.25, with no shares held in Treasury. This figure is provided for shareholders to determine their notification obligations under the UK Financial Conduct Authority's Disclosure and Transparency Rules.

AstraZeneca's Imfinzi (durvalumab) in combination with Bacillus Calmette-Guérin (BCG) has received US FDA approval for adult patients with BCG-naïve, high-risk non-muscle-invasive bladder cancer (NMIBC). This approval, based on the positive results from the POTOMAC Phase III trial, marks the first immunotherapy combination regimen for this patient population in over 30 years. The trial demonstrated a 32% reduction in the risk of high-risk disease recurrence, progression, or death, offering a significant advancement in treatment options.

The US FDA has extended the Prescription Drug User Fee Act (PDUFA) date for AstraZeneca's camizestrant, an investigational treatment for HR-positive, HER2-negative advanced breast cancer with emergent ESR1 mutation. The extension is to allow review of additional data requested by the FDA, following a non-majority vote from the Oncologic Drugs Advisory Committee in April 2026. AstraZeneca has provided new analyses, including ctDNA clearance data, which will be presented at ASCO 2026. Separately, the European Medicines Agency adopted a positive opinion for camizestrant on May 22, 2026, and the drug is already approved in UAE and Saudi Arabia.

AstraZeneca and Daiichi Sankyo's Datroway has received US FDA approval for the 1st-line treatment of adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy. This marks Datroway as the first TROP2-directed antibody drug conjugate approved for this specific patient population, offering a new standard of care beyond traditional chemotherapy. The approval is based on results from the TROPION-Breast02 Phase III trial, which demonstrated significant improvements in overall survival and progression-free survival.

AstraZeneca and Daiichi Sankyo's Enhertu has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for approval in the European Union. This recommendation is for Enhertu as a monotherapy to treat adult patients with previously treated unresectable or metastatic HER2-positive solid tumours who lack satisfactory treatment options. The positive opinion is based on clinically meaningful responses observed across a broad range of tumours in three Phase II trials: DESTINY-PanTumor02, DESTINY-Lung01, and DESTINY-CRC02.

AstraZeneca's camizestrant, in combination with a CDK4/6 inhibitor, has been recommended for approval in the European Union by the CHMP for the treatment of adult patients with ER-positive, HER2-negative locally advanced or metastatic breast cancer with an emergent ESR1 mutation. This positive opinion is based on pivotal SERENA-6 Phase III trial results, which showed the combination reduced the risk of disease progression or death by 56% and demonstrated a median progression-free survival of 16.0 months versus 9.2 months. If approved, camizestrant could reshape 1st-line treatment for patients in Europe with this type of advanced breast cancer, building on existing approvals in the UAE and Saudi Arabia.

AstraZeneca announced that its Executive Director and Chief Executive Officer, Pascal Soriot, acquired 18,359 ordinary shares on May 14, 2026. This transaction resulted from the vesting of an award under the AstraZeneca Performance Share Plan (AZPSP), which was granted on May 14, 2021. The award vested at 88% after a three-year performance period and a two-year holding period, with shares withheld to cover tax obligations. The fair market value of an ordinary share for tax purposes was 13,766 pence.

AstraZeneca announced that its drug Baxfendy (baxdrostat) has received US FDA approval as a first-in-class aldosterone synthase inhibitor for treating hypertension in adults whose blood pressure is not adequately controlled by other medications. The approval is based on positive BaxHTN Phase III trial results, which demonstrated statistically significant and clinically meaningful reductions in systolic blood pressure. This new treatment offers a novel approach to lowering blood pressure by inhibiting aldosterone production, addressing a significant unmet need for millions of patients.