AstraZeneca SEC Filings

AstraZeneca announced that the European Commission approved Koselugo (selumetinib) for adults with neurofibromatosis type 1 who have symptomatic, inoperable plexiform neurofibromas. The decision is based on the Phase III KOMET trial, which showed a 20% objective response rate in tumour size reduction versus 5% with placebo (p=0.01) by cycle 16.

Investigators reported a safety profile consistent with prior paediatric use. After 12 treatment cycles, placebo patients crossed over to Koselugo, and those on Koselugo continued for another 12 cycles. The medicine has recent approvals in Japan and other countries for this adult population, with additional reviews ongoing.

AstraZeneca PLC announced that the European Commission approved Tezspire (tezepelumab) as an add-on with intranasal corticosteroids for adult patients with severe chronic rhinosinusitis with nasal polyps (CRSwNP) who have not adequately responded to standard therapy. The decision is based on the Phase III WAYPOINT trial, where Tezspire reduced nasal polyp severity, nearly eliminated the need for surgery, and significantly reduced systemic corticosteroid use versus placebo.

The safety and tolerability profile was generally consistent with prior experience; the most frequent adverse events were COVID-19, nasopharyngitis and upper respiratory tract infection. CRSwNP affects approximately 320 million people worldwide, and nearly half of European patients remain uncontrolled despite current treatments. Tezspire is already approved for severe asthma in the US, EU, Japan and more than 60 countries, and was recently approved in the US for inadequately controlled CRSwNP in patients aged 12 and older.

Under AstraZeneca’s collaboration with Amgen, costs and profits are shared equally; Amgen records US product sales with AstraZeneca recognizing its US profit share as Collaboration Revenue, while AstraZeneca records product sales outside the US.

AstraZeneca (AZN) announced US FDA approval of Tezspire (tezepelumab) for chronic rhinosinusitis with nasal polyps (CRSwNP) as an add‑on maintenance treatment for adults and adolescents aged 12 years and older with inadequately controlled disease. This expands Tezspire beyond severe asthma into a second epithelial‑driven inflammatory condition, targeting thymic stromal lymphopoietin (TSLP).

The decision was supported by the Phase III WAYPOINT trial, where Tezspire delivered a statistically significant, clinically meaningful reduction in nasal polyp severity, with near‑elimination of surgery and significant reductions in systemic corticosteroid use versus placebo. CRSwNP affects up to approximately 320 million people worldwide, and many patients do not achieve lasting relief with current therapies. AstraZeneca and Amgen co‑develop and co‑commercialize Tezspire, sharing costs and profits; in the US, Amgen records product sales with AstraZeneca recognizing its share as Collaboration Revenue. A positive CHMP opinion has been adopted in the EU, and reviews are ongoing in multiple countries.

AstraZeneca reported a positive CHMP opinion recommending EU approval of a once-weekly, self-administered subcutaneous pre-filled pen of Saphnelo (anifrolumab) for adults with systemic lupus erythematosus alongside standard therapy.

The recommendation is based on interim Phase III TULIP-SC results showing a statistically significant and clinically meaningful reduction in disease activity versus placebo, with a safety profile consistent with the intravenous formulation. Subcutaneous Saphnelo is also under review in several other countries. Saphnelo IV is approved for moderate to severe SLE in more than 70 countries, including the US, EU and Japan, and more than 40,000 patients have been treated globally.

AstraZeneca notes it will pay Bristol-Myers Squibb a low to mid-teens royalty on sales of Saphnelo, depending on geography, under an existing license agreement.

AstraZeneca PLC filed a Form 6-K announcing a historic agreement with the US Government to lower prescription medicine costs for American patients while preserving biopharma innovation. The company will offer Direct-to-Consumer sales for eligible chronic-disease prescriptions at discounts of up to 80% off list prices and will participate in the TrumpRx.gov platform for reduced cash purchases.

The agreement includes a three-year delay of Section 232 tariffs as AstraZeneca onshores US manufacturing, supported by a previously announced $50 billion investment in US manufacturing and R&D over the next five years. The company reiterated an ambition to reach $80 billion in Total Revenue by 2030, with 50% expected from the US. Recent and upcoming US footprint expansions include a new Virginia facility (weight management/metabolic and ADC cancer portfolio), an expanded site in Coppell, Texas, a cell therapy facility in Rockville, Maryland, and a second major R&D center in Cambridge, Massachusetts slated to open in late 2026.

Specific terms of the agreement remain confidential.

AstraZeneca announced positive topline results from the Bax24 Phase III trial showing baxdrostat 2mg once daily met the primary endpoint in patients with treatment-resistant hypertension (rHTN). In a randomized, double-blind study of 218 patients over a 12-week double-blind period, baxdrostat produced a statistically significant and clinically meaningful reduction in ambulatory 24-hour average systolic blood pressure versus placebo, with efficacy sustained across the full 24-hour period including the higher-risk morning window. The company reported baxdrostat was generally well tolerated with a safety profile consistent with prior BaxHTN data. AstraZeneca said it will share data with regulators globally and present results at the American Heart Association sessions in November 2025. Baxdrostat, acquired via the CinCor transaction, is being developed for hypertension, primary aldosteronism, chronic kidney disease and heart-failure prevention, supported by its reported half-life of about 26–30 hours and selective aldosterone synthase inhibition.

AstraZeneca announced positive Phase III TROPION-Breast02 results for Datroway (datopotamab deruxtecan). The trial enrolled 644 patients and showed a statistically significant and clinically meaningful improvement in both overall survival (OS) and progression-free survival (PFS) versus investigator's choice chemotherapy as 1st-line treatment for patients with locally recurrent inoperable or metastatic triple-negative breast cancer (TNBC) for whom immunotherapy was not an option. Approximately 70% of metastatic TNBC patients are not candidates for immunotherapy, so chemotherapy remains the 1st-line standard of care for this group. TNBC represents about 15% of breast cancers globally (~345,000 diagnoses annually) and has a poor prognosis (median OS roughly 12 to 18 months, ~14% five-year survival). The safety profile was consistent with prior Datroway studies and data will be presented at an upcoming medical meeting and discussed with regulators.

AstraZeneca reported the total number of voting rights in the company as of 30 September 2025. The company states its issued share capital comprises 1,550,701,945 ordinary shares of US$0.25 and that no shares are held in treasury, giving a total of 1,550,701,945 voting rights. The notice explains this figure can be used by shareholders as the denominator to determine whether they must notify changes in their holdings under the UK Financial Conduct Authority's Disclosure and Transparency Rules.

The disclosure is a routine Transparency Directive update and does not include financial results, transactions, or forward guidance. Contact details for Investor Relations and Media are provided and the report is signed by the Company Secretary, Matthew Bowden, dated 01 October 2025.

AstraZeneca reported positive interim results from the DESTINY-Breast05 Phase III trial showing Enhertu (trastuzumab deruxtecan) produced a highly statistically significant and clinically meaningful improvement in invasive disease-free survival (IDFS) versus T-DM1 in patients with high-risk HER2-positive early breast cancer who had residual invasive disease after neoadjuvant therapy. Overall survival was not mature at the interim analysis and will be assessed later. The safety profile was consistent with known data and no new safety concerns were identified. Results will be presented at ESMO 2025 and shared with regulators; the trial enrolled 1,635 patients globally.