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AstraZeneca announced that its inhaled therapy Breztri Aerosphere has been approved in the United States for the maintenance treatment of asthma in patients aged 12 and older.

The approval makes Breztri the first and only triple-combination inhaler therapy for asthma, expanding its use beyond COPD. Clinical trials showed significant improvements in lung function and rapid onset of action compared to dual therapies.

The decision addresses a major unmet need, as many asthma patients remain uncontrolled on existing treatments, and marks a key milestone in respiratory care innovation.

Source: AstraZeneca
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The Investor 04-28-26
AstraZeneca's Tozorakimab Scores Third Positive Phase III Trial in COPD

AstraZeneca has reported positive results from the Phase III MIRANDA trial of tozorakimab, its experimental IL-33-targeting biologic for chronic obstructive pulmonary disease (COPD). The drug met its primary endpoint, delivering a statistically significant and clinically meaningful reduction in moderate-to-severe COPD exacerbations — both in former smokers and in the broader trial population including current smokers, across all stages of lung function severity.

MIRANDA is the third consecutive positive pivotal trial for tozorakimab in COPD, following the OBERON and TITANIA results announced in March. The drug works by blocking IL-33 signalling in two distinct ways, targeting both inflammation and the mucus dysfunction cycle that drives disease worsening. It was generally well tolerated with a safety profile consistent with earlier studies.

The results are significant given the scale of unmet need: COPD affects nearly 400 million people worldwide and is the third leading cause of death globally, yet more than half of patients continue to suffer exacerbations even on standard inhaled therapies. AstraZeneca said it will submit the data to regulatory authorities and present findings at an upcoming medical conference.
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WS Investor 04-20-26
AstraZeneca reported positive Phase III trial results showing that its immunotherapy combination significantly improves outcomes in early-stage liver cancer.

In the EMERALD-3 trial, the combination of Imfinzi (durvalumab), Imjudo (tremelimumab), lenvatinib, and transarterial chemoembolisation (TACE) achieved a statistically significant improvement in progression-free survival compared to TACE alone.

The treatment also demonstrated a trend toward improved overall survival, a key secondary endpoint, although further data are still being evaluated.

The regimen, known as STRIDE, combines dual immunotherapy with targeted therapy and a standard embolisation procedure, aiming to delay disease progression and recurrence in patients with unresectable hepatocellular carcinoma.

AstraZeneca stated that the safety profile was consistent with known data and that the results will be presented at a future medical meeting and submitted to global regulators.

The findings highlight the potential of earlier use of immunotherapy combinations to improve outcomes in liver cancer, a disease where many patients currently face progression within months after standard treatment.
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The Investor 04-02-26
AstraZeneca announced positive Phase III clinical trial results for its investigational therapy efzimfotase alfa (ALXN1850), targeting the rare bone disease hypophosphatasia (HPP).

The global clinical program showed strong results in pediatric patients, with the MULBERRY trial meeting its primary endpoint and demonstrating significant improvements in bone health. The CHESTNUT trial also confirmed favorable safety and tolerability in children switching from existing treatments.

In adolescents and adults, the HICKORY trial did not meet its primary endpoint overall, but showed meaningful benefits in certain subgroups, including improvements in mobility, fatigue, and pain.

Overall, the therapy demonstrated a favorable safety profile across studies and may offer a more convenient dosing regimen compared to current treatments, with the potential to reshape care for this rare disease pending regulatory review.
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The Investor 03-31-26
AstraZeneca announced that its investigational drug Tozorakimab met primary endpoints in two Phase III trials (OBERON and TITANIA) for chronic obstructive pulmonary disease (COPD).

The studies showed that tozorakimab significantly reduced the annual rate of moderate-to-severe COPD exacerbations compared with placebo, across both former smokers and the broader patient population. The treatment was also reported to be well tolerated with a favorable safety profile.

Tozorakimab is a potential first-in-class therapy targeting interleukin-33 (IL-33), designed to reduce inflammation and address mucus dysfunction—key drivers of COPD progression.

The results mark the first successful Phase III confirmation for an IL-33–targeting biologic in COPD, a disease affecting nearly 400 million people globally. AstraZeneca plans to present detailed data at upcoming medical conferences while continuing additional late-stage trials.
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The Investor 03-27-26
AstraZeneca said the European Commission has approved Imfinzi (durvalumab) in combination with FLOT chemotherapy as a perioperative treatment for adults with resectable early-stage and locally advanced gastric and gastroesophageal junction cancers in the EU.

The approval is based on results from the Phase III MATTERHORN trial, which showed significant improvements in survival outcomes. Patients receiving the Imfinzi-based regimen had a 29% lower risk of disease progression, recurrence, or death compared with chemotherapy alone, while the risk of death was reduced by 22%. About 69% of patients treated with the combination were alive after three years versus 62% in the control group.

The therapy involves treatment before and after surgery followed by Imfinzi monotherapy, marking the first immunotherapy regimen approved in the EU for this early treatment setting. AstraZeneca said the approval strengthens its portfolio of perioperative cancer therapies and could establish a new standard of care for early gastric and gastroesophageal cancers.
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WS Investor 03-16-26
AstraZeneca’s Calquence combo wins US approval as first fixed-duration, all-oral frontline CLL regimen

AstraZeneca has received US Food and Drug Administration approval for Calquence (acalabrutinib) in combination with venetoclax as the first all-oral, fixed-duration treatment for adult patients with previously untreated chronic lymphocytic leukaemia (CLL) and small lymphocytic lymphoma (SLL).

The approval is based on results from the Phase III AMPLIFY trial, which showed statistically significant and clinically meaningful improvements in progression-free survival (PFS) compared with standard chemoimmunotherapy. At three years, 77% of patients treated with the Calquence plus venetoclax combination remained progression free, versus 67% in the chemotherapy arm. The regimen reduced the risk of disease progression or death by 35% (hazard ratio 0.65; p=0.0038), with median PFS not yet reached compared to 47.6 months for chemoimmunotherapy.

The combination is administered for a fixed duration of 14 cycles (approximately 14 months), offering an alternative to continuous treatment approaches that can carry cumulative side effects. Safety findings were consistent with the known profile of Calquence, with no new safety signals identified.

CLL is the most common adult leukaemia, with an estimated 18,500 patients treated in the first-line setting in the US in 2024. The newly approved regimen is positioned to reshape frontline treatment decisions by providing a time-limited, chemotherapy-free option.

Calquence plus venetoclax is already approved in the EU, UK and Canada, with additional regulatory reviews ongoing globally.
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The Investor 02-20-26
AstraZeneca reported strong full-year and fourth-quarter 2025 results, supported by broad-based commercial growth and robust pipeline progress. FY 2025 total revenue rose 8% at constant exchange rates to $58.7 billion, driven by Oncology, CVRM, Respiratory & Immunology, and Rare Disease, with growth across all major regions. Core operating profit increased 9%, while core EPS climbed 11% to $9.16. Reported EPS rose 45% to $6.60.

In Q4 2025, total revenue increased 2% at constant exchange rates to $15.5 billion, with product sales up 7%. Reported EPS grew 47% to $1.50, while core EPS was broadly flat at $2.12. The company declared a second interim dividend of $2.17 per share, bringing the full-year dividend to $3.20, up 3% year on year.

During the past twelve months, AstraZeneca delivered 16 positive Phase 3 readouts and secured 43 approvals in major regions, bringing its total to 16 blockbuster medicines. CEO Pascal Soriot said momentum is continuing into 2026, with more than 20 Phase 3 readouts expected this year and over 100 Phase 3 trials ongoing, including a growing number using transformative technologies.

Separately, AstraZeneca’s ordinary shares began trading on the New York Stock Exchange on February 2, creating a harmonised listing across London, New York and Stockholm.
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WS Investor 02-10-26
AstraZeneca said the US Food and Drug Administration has issued a complete response letter for the biologics license application covering subcutaneous administration of Saphnelo in systemic lupus erythematosus, but the company has already submitted the requested information and is working with regulators to advance the review.

The company expects an FDA decision in the first half of 2026, while intravenous Saphnelo remains commercially available. The update follows positive Phase III TULIP-SC trial results and comes after the European Union approved the subcutaneous formulation in December 2025, reinforcing AstraZeneca’s confidence in the therapy’s safety and efficacy profile.
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The Investor 02-05-26
AstraZeneca said its immunotherapy Imfinzi (durvalumab) has been recommended for approval in the European Union as part of a perioperative treatment regimen for patients with resectable, early-stage and locally advanced gastric and gastroesophageal junction cancers. The positive opinion from the European Medicines Agency’s CHMP is based on results from the Phase III MATTERHORN trial, which showed a 29% reduction in the risk of disease progression, recurrence or death and a 22% reduction in the risk of death compared with chemotherapy alone.

If approved, the Imfinzi-based regimen would become the first immunotherapy-based perioperative treatment for this patient population in the EU, potentially setting a new standard of care in early gastric and gastroesophageal cancers.
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Global Finance News 02-02-26