Astrazeneca Plc SEC Filings

AstraZeneca PLC reported that shareholders approved a special resolution to adopt new articles of association to proceed with the harmonisation of its equity listing structure. The motion passed by poll with 1,222,275,967 votes for (99.36% of votes cast) and 7,861,875 against (0.64%), from 1,230,137,842 votes cast in total (79.33% of issued share capital); 2,628,613 votes were withheld.

The timetable replicates prior guidance: termination of the ADR programme, delisting of AstraZeneca ADSs, and cancellation of the listing and trading of AstraZeneca US Bonds on Nasdaq is expected on 2 February 2026. Trading in AstraZeneca Shares and AstraZeneca US Bonds on the NYSE is expected to commence by 8:00 a.m. (ET) on 2 February 2026. Issuance of AstraZeneca DIs to relevant CREST participant accounts is expected on or around 2 February 2026, and statements of entitlement for existing CSN Eligible Certificated Shareholders and CSN Participants by no later than 16 February 2026.

Issued shares were 1,550,712,906 ordinary shares as of 30 October 2025.

AstraZeneca PLC reported its total voting rights under the UK Disclosure and Transparency Rule 5.6.1. As at 31 October 2025, the company’s issued share capital with voting rights comprised 1,550,712,906 ordinary shares of US$0.25. No shares are held in Treasury, so the total number of voting rights is 1,550,712,906.

This figure serves as the denominator shareholders use to assess whether they must notify their interest or any change in interest in line with UK transparency rules. The company files annual reports on Form 20-F and indicated it is not furnishing information under Rule 12g3-2(b).

AstraZeneca PLC furnished a Form 6-K announcing an update to its corporate governance documents. Exhibit 99.1 contains the company’s Articles of Association, adopted by special resolution passed on 3 November 2025. The filing indicates AstraZeneca files annual reports on Form 20-F and is not furnishing information under Rule 12g3-2(b).

AstraZeneca PLC announced that Non-Executive Director Euan Ashley has been appointed a director of DexCom, Inc., effective 24 October 2025.

This routine governance disclosure was made pursuant to Listing Rule 6.4.9 (2). The notice was signed by Company Secretary Matthew Bowden on 28 October 2025.

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.