AstraZeneca PLC filings document the disclosures of a foreign private issuer focused on prescription medicines across oncology, rare diseases, cardiovascular, renal and metabolism, respiratory, and immunology. The company’s Form 6-K reports include quarterly operating results, product sales, alliance and collaboration revenue, EPS measures, and management commentary on medicine performance and pipeline progress.
Other filings record FDA advisory-committee and approval updates for medicines such as TRUQAP, BREZTRI, SAPHNELO, camizestrant, and ULTOMIRIS; Phase III trial disclosures; licensing arrangements; Board changes; total voting rights; and admission of additional ordinary shares. These documents also provide capital-structure and governance information relevant to AstraZeneca’s UK issuer framework and SEC foreign-issuer reporting obligations.
AstraZeneca PLC has voluntarily withdrawn the listing/registration of its 1.200% Notes due 2026 from the New York Stock Exchange via Form 25, with the Exchange certifying compliance with the applicable withdrawal rules.
AstraZeneca reports that the US FDA has extended the Prescription Drug User Fee Act (PDUFA) decision date for the New Drug Application for camizestrant combined with a CDK4/6 inhibitor as 1st-line treatment for HR-positive, HER2-negative advanced breast cancer with emergent ESR1 mutations, to review additional requested data from the Phase III SERENA-6 trial.
The company has submitted new analyses, including ctDNA clearance data linked to longer-term efficacy that will be presented at ASCO 2026. In contrast to the extended US timeline, the European Medicines Agency’s human medicines committee has issued a positive opinion recommending approval, and camizestrant is already approved in this setting in the UAE and Saudi Arabia, with further regulatory reviews ongoing in Japan and other countries.
AstraZeneca PLC reports that Datroway (datopotamab deruxtecan), co-developed with Daiichi Sankyo, has been approved in the US for adults with unresectable or metastatic triple-negative breast cancer who are not candidates for PD-1/PD-L1 inhibitor therapy. The approval, granted after Priority Review, is based on the Phase III TROPION-Breast02 trial, where Datroway improved median overall survival by 5.0 months versus chemotherapy, with a hazard ratio of 0.79. Datroway also reduced the risk of disease progression or death by 43% and achieved a 64% objective response rate compared with 30% for chemotherapy. The medicine is now approved for three indications in the US and is included as a Category 1 Preferred 1st-line option in the NCCN Guidelines for this TNBC population. Global regulatory reviews and an extensive development programme across multiple cancers are ongoing.
AstraZeneca reported that the European Medicines Agency’s CHMP has recommended Enhertu (trastuzumab deruxtecan), co-developed with Daiichi Sankyo, for approval in the EU as a monotherapy for adults with unresectable or metastatic HER2‑positive (IHC 3+) solid tumours who have received prior treatment and lack satisfactory options.
This proposed tumour‑agnostic indication is supported by three Phase II trials. In DESTINY‑PanTumor02, Enhertu achieved a confirmed objective response rate of 51.4% and a median duration of response of 14.2 months in 111 patients with IHC 3+ solid tumours, including biliary tract, bladder, cervical, endometrial, ovarian, pancreatic and other cancers. DESTINY‑Lung01 showed a 52.9% response rate and 6.9‑month median response in 17 patients with IHC 3+ non‑small cell lung cancer, while DESTINY‑CRC02 reported a 46.9% response rate and 5.5‑month median response in 64 patients with IHC 3+ colorectal cancer. The safety profile was consistent with earlier studies, with no new concerns identified.
AstraZeneca reports that the EU’s CHMP has issued a positive opinion recommending approval of camizestrant, an investigational next‑generation oral SERD, in combination with a CDK4/6 inhibitor as 1st‑line treatment for ER‑positive, HER2‑negative locally advanced or metastatic breast cancer with an emergent ESR1 mutation.
The recommendation is based on the Phase III SERENA‑6 trial, where the camizestrant combination cut the risk of disease progression or death by 56% versus an aromatase inhibitor plus CDK4/6 inhibitor, improving median progression‑free survival to 16.0 months from 9.2 months. A later analysis showed a statistically significant improvement in time to second progression and maturing overall‑survival data trending in favour of camizestrant. Safety was consistent with known profiles of the component drugs.
Camizestrant is already approved in the UAE and Saudi Arabia in this setting, and regulatory applications are under review in the US, Japan and other countries, underscoring AstraZeneca’s broader strategy in HR‑positive breast cancer and its expanding oncology portfolio.
ASTRAZENECA PLC officer Sharma Mani reported an open-market sale of 11,893 Ordinary Shares on May 20, 2026 at an average price of $185.78 per share, based on a GBP139.35 price and a stated currency conversion rate. After this transaction, Mani directly holds 19,262.4659 Ordinary Shares.
AstraZeneca PLC reported that an award of ordinary shares under the AstraZeneca Performance Share Plan vested to Chief Executive Officer Pascal Soriot on 14 May 2026. The award, originally granted on 14 May 2021, was subject to performance measures over three years followed by a two-year holding period.
Application of these performance measures resulted in 88% of the award vesting, with the remainder lapsing. After dividend reinvestment and tax withholding, Mr Soriot acquired 18,359 ordinary shares for nil consideration, changing his beneficial interests in AstraZeneca shares. The fair market value at vest for tax purposes was 13,766 pence per share.
AstraZeneca reports that the US FDA has approved Baxfendy (baxdrostat), a first-in-class aldosterone synthase inhibitor, for adults with hypertension whose blood pressure remains uncontrolled on other medicines.
Approval is based on the Phase III BaxHTN trial in 796 patients, where Baxfendy 2mg lowered seated systolic blood pressure by 15.7 mmHg from baseline and 9.8 mmHg versus placebo at week 12. Both 2mg and 1mg doses showed statistically significant and clinically meaningful effects and were generally well tolerated. Baxfendy is also being studied in other aldosterone-driven cardiorenal conditions, supporting AstraZeneca’s broader cardiovascular, renal and metabolism portfolio.
AstraZeneca reports that the US FDA has approved Enhertu (trastuzumab deruxtecan), co-developed with Daiichi Sankyo, for two new HER2-positive early breast cancer uses in the neoadjuvant and adjuvant settings. These approvals move the drug into earlier, potentially curative stages of disease.
In DESTINY-Breast11, neoadjuvant Enhertu followed by THP achieved a pathologic complete response rate of 67.3% versus 56.3% with ddAC-THP, an 11.2% improvement. In DESTINY-Breast05, adjuvant Enhertu reduced the risk of invasive disease recurrence or death by 53% versus T-DM1, with three-year invasive disease-free survival of 92.4% versus 83.7%.
No new overall safety concerns were seen, but drug-related interstitial lung disease/pneumonitis occurred in 9.6% of Enhertu patients versus 1.6% with T-DM1, including two Grade 5 events. Following these US approvals, AstraZeneca will pay Daiichi Sankyo $155 million in milestones, while US Enhertu sales are recognized by Daiichi Sankyo.
AstraZeneca reported positive interim Phase III VOLGA trial results for its immunotherapy Imfinzi in muscle-invasive bladder cancer. Perioperative Imfinzi plus neoadjuvant enfortumab vedotin significantly improved event-free and overall survival versus standard surgery in patients ineligible for or declining cisplatin-based chemotherapy.
A second regimen combining perioperative Imfinzi, Imjudo and neoadjuvant enfortumab vedotin delivered a significant event-free survival benefit and a favourable, though not yet statistically significant, overall survival trend. Safety was consistent with known profiles, with no new safety signals. AstraZeneca plans to present the data at a medical meeting and share them with global regulators, adding to an already broad set of Imfinzi indications across bladder, lung, liver and other cancers.