ASTRAZENECA (AZN) Company Report

Alexion, AstraZeneca Rare Disease announced that Koselugo (selumetinib) received US FDA approval for the treatment of adult patients with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN).
This approval was based on positive results from the KOMET Phase III trial, which showed a 20% overall response rate in tumor size reduction for Koselugo, compared to 5% with placebo.
The expanded approval for adults, alongside the recently approved granule formulation for young children, aims to provide continuity of care for NF1 PN patients in the US.

5 days ago

6-K

AstraZeneca PLC Reports Major Holding by The Capital Group Companies, Inc.

AZN

The Capital Group Companies, Inc. notified AstraZeneca PLC of an acquisition of voting rights, crossing a significant ownership threshold.
As of November 13, 2025, The Capital Group Companies, Inc. holds 5.017815% of the voting rights in AstraZeneca PLC, totaling 77,811,893 voting rights.
This represents an increase from their previous notification position of 4.997854%.
The voting rights are held by accounts under the discretionary investment management of Capital Group's investment management companies, rather than for Capital Group's own account.

7 days ago

6-K

AstraZeneca Reports Strong Q3 2025 Growth and Reaffirms Full-Year Guidance

AZN

Earnings

Guidance Update

New Projects/Investments

AstraZeneca reported strong financial results for the first nine months of 2025, with total revenue growing by 11% and core EPS increasing by 15% at constant exchange rates, while reiterating its full-year guidance for high single-digit revenue growth and low double-digit core EPS growth.
The company saw broad-based growth, including a 16% increase in its oncology franchise, and maintained a core operating margin of 33.3%, remaining on track for its mid-30s operating margin target for 2026 and $80 billion revenue ambition for 2030.
AstraZeneca achieved 31 regulatory approvals and positive results from 16 phase three trials in 2025, with key pipeline assets like Baxdrostat and surovatamab having multi-billion dollar peak-year revenue potential, and secured a landmark agreement with the U.S. government providing a three-year exemption from tariffs.

Nov 6, 2025, 1:00 PM

Transcript

AstraZeneca Reports Strong Q3 2025 Performance and Reaffirms Full-Year Guidance

AZN

Earnings

Guidance Update

New Projects/Investments

AstraZeneca reported strong financial performance for the first nine months of 2025, with total revenue growing by 11% and core EPS increasing by 15%. The core operating margin reached 33.3%.
Growth was broad-based, with the oncology franchise up 16%, biopharmaceuticals up 8%, and rare disease up 6%. Revenues in the U.S. and emerging markets outside of China saw increases of 11% and 21%, respectively.
The company achieved 31 regulatory approvals and announced positive results from 16 Phase III trials in 2025, including key readouts for DESTINY-Breast05, DESTINY-Breast11, ROPION-Breast02, BAXC24, and TULIP-SC.
AstraZeneca reiterated its full-year guidance, anticipating total revenue to increase by high single-digit and core EPS by low double-digit % at constant exchange rates. The company remains on track for its 2026 margin target of mid-30s and $80 billion 2030 revenue ambition.
A landmark agreement with the U.S. government provides clarity on pricing and a three-year exemption from tariffs, with the U.S. projected to account for around 50% of total revenue by 2030.

Nov 6, 2025, 1:00 PM

Transcript

AstraZeneca Reports Strong Q3 2025 Performance and Reaffirms Full-Year Guidance

AZN

Earnings

Guidance Update

New Projects/Investments

AstraZeneca reported robust financial results for the first nine months of 2025, with total revenue growing by 11% and core EPS increasing by 15%.
The company reiterated its full-year guidance, anticipating total revenue and core EPS to increase by high single-digit and low double-digit %, respectively, at constant exchange rates.
Key franchises demonstrated strong growth, with Oncology revenue up 16% to $18.6 billion and Biopharmaceuticals revenue up 8% to $17.1 billion in the first nine months.
AstraZeneca remains on track for its 2026 margin target of mid-30s and its $80 billion 2030 revenue ambition, supported by over $10 billion in risk-adjusted peak-year revenue opportunities from 2026 pipeline readouts.
A landmark agreement with the U.S. government provides greater clarity on pricing and a three-year exemption from tariffs, with the U.S. projected to account for around 50% of total revenue by 2030.

Nov 6, 2025, 1:00 PM

Transcript

AstraZeneca Reports Strong Q3 2025 Results and Reaffirms Full-Year Guidance

AZN

Earnings

Guidance Update

New Projects/Investments

AstraZeneca reported Total Revenue of $15,191 million for Q3 2025, an increase of 12% (actual), and Core EPS of $2.38, up 14% (actual), with 9M 2025 Total Revenue reaching $43,236 million.
The company reiterated its FY 2025 guidance for Total Revenue to increase by a high single-digit percentage and Core EPS by a low double-digit percentage at constant exchange rates.
AstraZeneca achieved 16 positive Phase III readouts and 31 approvals in major regions during the first nine months of 2025.
Strategic initiatives include breaking ground on a $4.5 billion US manufacturing facility in October 2025, part of a $50 billion investment in US manufacturing and R&D by 2030, and an agreement with the US government to lower medicine costs.
Shareholders approved a listing harmonization plan on November 3, 2025, allowing trading on the London Stock Exchange, Nasdaq Stockholm, and New York Stock Exchange from February 2, 2026.

Nov 6, 2025, 12:36 PM

6-K

AstraZeneca PLC Adopts New Articles of Association and Details Harmonised Listing Structure

AZN

Delisting/Listing Issues

Dividends

AstraZeneca PLC adopted new Articles of Association by special resolution on November 3, 2025.
The new Articles detail a Harmonised Listing Structure, which proposes a direct listing of Ordinary Shares on the NYSE.
This structure will replace the company's existing United States equity listing of ADSs on Nasdaq, leading to the cancellation of ADSs upon implementation.
The company's Ordinary Shares are valued at US$0.25 each.
The Articles also include provisions for dividend declaration, interim dividends, and scrip dividends.

Nov 3, 2025, 5:36 PM

6-K

AstraZeneca's Koselugo Approved in EU for Adult NF1 Patients

AZN

Product Launch

New Projects/Investments

AstraZeneca's Koselugo (selumetinib) received European Union (EU) approval in October 2025 for the treatment of symptomatic, inoperable plexiform neurofibromas (PN) in adult patients with neurofibromatosis type 1 (NF1).
The approval was based on results from the KOMET Phase III trial, which demonstrated a 20% objective response rate in tumour size reduction.
This milestone extends the treatment's availability to adults, addressing an unmet need in the rare disease community and providing continuity of care.
Koselugo is part of a global strategic collaboration between AstraZeneca and MSD for co-development and co-commercialisation.

Oct 28, 2025, 12:02 PM

6-K

AstraZeneca's Tezspire Approved in EU for Chronic Rhinosinusitis with Nasal Polyps

AZN

Product Launch

AstraZeneca and Amgen's Tezspire (tezepelumab) has received approval in the European Union (EU) as an add-on therapy for adult patients with severe chronic rhinosinusitis with nasal polyps (CRSwNP) who have not adequately responded to standard treatment.
The approval is based on positive WAYPOINT Phase III trial results, which demonstrated a statistically significant reduction in nasal polyp severity, near-elimination of the need for surgery, and significantly reduced systemic corticosteroid use versus placebo.
This approval addresses a substantial unmet medical need, as CRSwNP affects approximately 320 million people worldwide, and nearly half of European patients remain uncontrolled with existing therapies.
Tezspire is also approved for severe asthma in multiple regions, including the US, EU, and Japan, and is being explored in Phase III trials for chronic obstructive pulmonary disease (COPD) and eosinophilic esophagitis (EoE).

Oct 22, 2025, 12:07 PM

6-K

AstraZeneca's Tezspire Receives US FDA Approval for Chronic Rhinosinusitis with Nasal Polyps

AZN

Product Launch

New Projects/Investments

The US FDA has approved AstraZeneca and Amgen's Tezspire (tezepelumab) for the add-on maintenance treatment of adult and paediatric patients aged 12 years and older with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP).
This approval broadens Tezspire's indication, making it the first and only biologic targeting thymic stromal lymphopoietin (TSLP) approved for CRSwNP.
The approval was supported by the WAYPOINT Phase III trial, which demonstrated a statistically significant and clinically meaningful reduction in nasal polyp severity, near-elimination of surgery, and significant reduction in systemic corticosteroid use.
AstraZeneca and Amgen jointly commercialize Tezspire in the US, sharing costs and profits equally.

Oct 20, 2025, 11:12 AM

6-K

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