Astrazeneca Plc SEC Filings

AstraZeneca PLC disclosed a routine shareholding change involving a board member and his spouse. On 17 December 2025, Non-Executive Director and PDMR Philip Broadley gifted 5,735 ordinary shares of US$0.25 each in AstraZeneca to his spouse, Gillian Broadley, for no payment. The transfer was carried out outside a trading venue and is classified as a gift, with matching notifications filed for both the director (as the giver) and his spouse (as the recipient). This update is a standard regulatory disclosure of dealings by persons discharging managerial responsibilities and their closely associated persons, and does not change the total number of AstraZeneca shares outstanding.

AstraZeneca reports that the European Union has approved its lupus medicine Saphnelo (anifrolumab) for subcutaneous self-administration in a once-weekly 120mg pre-filled pen for adult patients with systemic lupus erythematosus receiving standard therapy. The decision follows a positive Phase III TULIP-SC trial, where subcutaneous Saphnelo produced a statistically significant and clinically meaningful reduction in disease activity versus placebo.

The new at-home option complements Saphnelo IV infusion, which is already approved for moderate to severe SLE in more than 70 countries and has been used by more than 40,000 patients globally. AstraZeneca highlights that about 70% of SLE patients on biologics in Europe use subcutaneous self-administration, so this route may help reach more patients while expanding treatment choice, with sales continuing to generate low to mid-teens royalties payable to Bristol-Myers Squibb.

AstraZeneca reports that Enhertu (trastuzumab deruxtecan) plus pertuzumab has been approved in the US as a 1st-line treatment for adults with unresectable or metastatic HER2-positive breast cancer, following Priority Review and Breakthrough Therapy Designation.

The approval is based on the Phase III DESTINY-Breast09 trial, where the combination reduced the risk of disease progression or death by 44% versus standard THP therapy and achieved a median progression-free survival of 40.7 months compared with 26.9 months for THP, with a safety profile consistent with the individual drugs.

This decision triggers a $150m milestone payment from AstraZeneca to Daiichi Sankyo for this 1st-line HER2-positive metastatic breast cancer indication, while US sales of Enhertu are recognised by Daiichi Sankyo.

AstraZeneca PLC reports that the US FDA has approved Imfinzi (durvalumab) in combination with FLOT chemotherapy as the first and only perioperative immunotherapy for adults with resectable, early-stage and locally advanced (Stages II, III, IVA) gastric and gastroesophageal junction cancers. The regimen includes Imfinzi plus chemotherapy before surgery, followed by Imfinzi plus chemotherapy and then Imfinzi alone.

The approval is based on the Phase III MATTERHORN trial, where the Imfinzi-based perioperative regimen reduced the risk of disease progression, recurrence or death by 29% (EFS HR 0.71) versus chemotherapy alone, and reduced the risk of death by 22% (OS HR 0.78). An estimated 69% of patients on the Imfinzi regimen were alive at three years versus 62% with chemotherapy alone, with safety broadly consistent with known profiles. The submission was reviewed under Project Orbis and is also under review in multiple other countries and regions.

AstraZeneca PLC plans to invest $2 billion to expand its manufacturing footprint in Maryland, adding major capacity for cancer, rare and chronic disease medicines. The company will significantly expand its biologics facility in Frederick, nearly doubling commercial manufacturing capacity and supporting 200 new highly skilled jobs and 900 construction roles, with operations expected in 2029. A new clinical manufacturing facility in Gaithersburg will focus on development and clinical supply of innovative molecules, creating 100 new jobs, retaining 400 roles and supporting 1,000 construction-related jobs, and is also expected to be fully operational in 2029.

The investment supports a total of 2,600 jobs across the two Maryland sites and will, for the first time, bring production across AstraZeneca's rare disease portfolio onshore in the US. This is the fourth major US manufacturing investment announced this year and forms part of AstraZeneca's previously announced historic $50 billion commitment to medicines manufacturing and R&D.

AstraZeneca, through its Alexion rare disease unit, reports that the US FDA has approved Koselugo (selumetinib) for adult patients with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN). This extends Koselugo beyond its existing paediatric NF1 PN use and offers an approved oral treatment option for adults with this rare, progressive genetic condition.

The approval is based on the global Phase III KOMET trial, where Koselugo achieved a confirmed overall response rate of 20% (14 of 71 patients) in tumour volume reduction by cycle 16, compared with 5% (4 of 74) on placebo, with 86% of responders maintaining benefit for at least six months. Safety in adults was consistent with the established paediatric profile. Koselugo has also recently been approved for adults with NF1 PN in the EU, Japan and other countries, with additional regulatory reviews ongoing.

AstraZeneca PLC has published a Form 6-K reporting a TR-1 notification of major holdings. The Capital Group Companies, Inc. has crossed the 5% disclosure threshold in AstraZeneca’s voting rights. The group now holds a total of 77,811,893 voting rights, representing 5.017815% of AstraZeneca’s voting rights.

These voting rights are held indirectly through shares in two lines: common stock with ISIN GB0009895292 accounting for 4.239936% of voting rights, and depository receipts with ISIN US0463531089 accounting for 0.777879%. The position was previously 4.997854%, so this notice reflects a small increase above the 5% reporting threshold.

AstraZeneca PLC reported a Director/PDMR shareholding update. The company was notified that Chief Financial Officer Aradhana Sarin executed a sale of 15,000 American Depositary Shares (ADSs) at $88.6345 per ADS. The transaction occurred on 12 November 2025 and was conducted on XNAS.

Two ADSs are equivalent to one ordinary share of $0.25 each. The notification was made in accordance with the EU Market Abuse Regulation as it forms part of UK law.

AstraZeneca PLC reported a Director/PDMR shareholding update. On 7 November 2025, CEO Pascal Soriot gifted 136,537 ordinary shares of $0.25 each in AstraZeneca PLC to family members for nil consideration, and therefore ceased to be beneficially interested in those shares.

The transaction was conducted outside a trading venue and is disclosed as a gift under EU Market Abuse Regulation requirements as retained in UK law.