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AstraZeneca PLC - $AZN STOCK NEWS

Welcome to our dedicated page for AstraZeneca PLC news (Ticker: $AZN), a resource for investors and traders seeking the latest updates and insights on AstraZeneca PLC stock.

AstraZeneca PLC (AZN) is a British-Swedish multinational pharmaceutical and biotechnology company headquartered in Cambridge, England. Formed in 1999 through the merger of Astra AB of Sweden and Zeneca Group PLC of the UK, AstraZeneca is known for its extensive research and development in the field of pharmaceuticals and biotechnology.

The company operates globally and generates a significant portion of its revenue from international markets, with the United States accounting for nearly one-third of its sales. AstraZeneca’s product portfolio includes a wide range of branded drugs across several major therapeutic areas such as gastrointestinal, diabetes, cardiovascular, respiratory, oncology, immunology, and rare diseases.

Recent achievements include a global license agreement with Nona Biosciences to develop preclinical monoclonal antibodies aimed at creating targeted therapies in oncology. The agreement could potentially bring Nona Biosciences up to $575 million upon achieving specified milestones, as well as tiered royalty payments on net sales. AstraZeneca continues to lead in the development of tumor-targeted therapies using cutting-edge technology.

Another noteworthy development is AstraZeneca's collaboration with AbelZeta Pharma to co-develop C-CAR031, a GPC3-targeted CAR-T therapy for treating hepatocellular carcinoma (HCC). The initial clinical results presented at the 2024 ASCO Annual Meeting showed promising safety and efficacy data.

Moreover, AstraZeneca has entered into a significant agreement with Compugen Ltd. to develop rilvegostomig, a PD-1/TIGIT bispecific antibody currently in Phase 3 trials for non-small cell lung cancer and biliary tract cancer. This partnership underscores AstraZeneca’s commitment to advancing innovative cancer therapies through strategic collaborations.

With its industry-leading capabilities, AstraZeneca is well-positioned to continue making significant strides in healthcare, providing effective treatments for a variety of diseases and maintaining its reputation as a global leader in pharmaceuticals and biotechnology.

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AstraZeneca's ECHO Phase III trial revealed that CALQUENCE® (acalabrutinib) combined with bendamustine and rituximab significantly reduced the risk of disease progression or death by 27% in untreated mantle cell lymphoma (MCL) patients compared to standard chemoimmunotherapy. Median progression-free survival (PFS) was 66.4 months with CALQUENCE vs. 49.6 months with the standard treatment. The study demonstrated a favorable trend in overall survival (OS) but the data remains immature. Safety profiles were consistent with previous findings, and no new safety signals were identified. These results were presented at the European Hematology Association (EHA) 2024 Hybrid Congress in Madrid.

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AstraZeneca's FARXIGA® (dapagliflozin) has received FDA approval for glycemic control in pediatric patients aged 10 years and older with type-2 diabetes (T2D). This approval is based on positive results from the T2NOW Phase III trial, which showed significant A1C reductions compared to placebo (-0.62% for FARXIGA vs. +0.41% for placebo). The approval extends the previously approved use of FARXIGA in adults as an adjunct to diet and exercise.

FARXIGA demonstrated a well-characterized safety profile consistent with adult studies and is now approved in 126 countries, including the EU. AstraZeneca emphasizes this approval as a milestone for pediatric T2D patients, addressing the rising incidence of T2D in children and adolescents, who often face earlier and faster disease progression compared to adults.

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AstraZeneca's supplemental New Drug Application (sNDA) for TAGRISSO® (osimertinib) has received Priority Review from the FDA for treating adult patients with unresectable, Stage III EGFR-mutated non-small cell lung cancer (NSCLC) post-chemoradiotherapy. The decision is based on the LAURA Phase III trial, which indicated a significant extension in median progression-free survival (PFS) of more than three years. TAGRISSO was also granted Breakthrough Therapy Designation for this setting. The FDA action date is anticipated in Q4 2024. TAGRISSO showed an 84% reduction in the risk of disease progression or death compared to placebo, with a PFS of 39.1 months versus 5.6 months with placebo. Safety profiles were consistent with no new concerns identified. Additionally, TAGRISSO is approved in over 100 countries for various indications in treating EGFR-mutated NSCLC.

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I-Mab (NASDAQ: IMAB) has announced the appointment of Dr. Phillip Dennis as Chief Medical Officer, effective June 17, 2024. Dr. Dennis will lead I-Mab's global clinical development and join the Executive Leadership Team. With two decades of oncology drug development experience, including key roles at Sanofi and AstraZeneca, Dr. Dennis brings significant expertise. His appointment aims to advance I-Mab's clinical pipeline, particularly for treatments like uliledlimab, givastomig, and ragistomig. Before his industry roles, Dr. Dennis was a professor at Johns Hopkins University and a senior investigator at the US National Cancer Institute.

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Nucleus RadioPharma announced the closing of a Series A extension funding round with AstraZeneca as a new investor. The funding aims to expand Nucleus's development, supply, and commercial manufacturing capabilities for targeted radiotherapies and theranostics, improving global patient access. Dr. Tyrell Rivers, Executive Director of Corporate Ventures at AstraZeneca, joined Nucleus’s Board of Directors. The precision of theranostics, combining diagnostics and therapeutics through radiotracers, offers a promising treatment for metastatic cancers, minimizing side effects compared to traditional methods. Charles S. Conroy, CEO of Nucleus, highlighted the remarkable effectiveness and safety of these drugs. The funding will facilitate large-scale production, addressing the challenges of the perishable nature of radiopharmaceuticals and enhancing their accessibility for cancer treatment worldwide.

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AbelZeta Pharma has reported preliminary data from its first human trial of C-CAR031, a GPC3-targeting CAR-T therapy for advanced hepatocellular carcinoma (HCC), presented at the 2024 ASCO Annual Meeting. The study showed a 91.3% disease control rate (DCR) and a 56.5% objective response rate (ORR) across all dose levels, with an ORR of 75.0% at dose level 4. Tumor reductions were observed in 91.3% of patients, with a median reduction of 42.2%. The median overall survival (mOS) was 11.14 months. Safety data indicated manageable side effects, with no dose-limiting toxicity or ICANS observed, and most cytokine release syndrome cases were mild.

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AstraZeneca's TAGRISSO® (osimertinib) demonstrated a significant improvement in progression-free survival (PFS) for patients with unresectable, Stage III EGFR-mutated lung cancer, as shown in the LAURA Phase III trial. In the trial, TAGRISSO reduced the risk of disease progression or death by 84% compared to placebo (HR 0.16; 95% CI 0.10-0.24; p<0.001). Median PFS was 39.1 months for TAGRISSO versus 5.6 months for placebo. The trial included 216 patients and results were presented at the 2024 ASCO Annual Meeting and published in The New England Journal of Medicine. The study noted a favorable trend in overall survival, though data is still maturing. Safety results were consistent with previous studies, with Grade 3 or higher adverse events in 35% of TAGRISSO patients. TAGRISSO is already approved in over 100 countries for various indications. The drug's efficacy cements its role as a critical therapy in managing EGFR-mutated NSCLC.

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AstraZeneca's IMFINZI® (durvalumab) has shown significant survival benefits in a global Phase III ADRIATIC trial for -stage small cell lung cancer (LS-SCLC). The trial revealed that IMFINZI reduced the risk of death by 27% compared to placebo, with an estimated median overall survival (OS) of 55.9 months versus 33.4 months for placebo.

Additionally, 57% of patients treated with IMFINZI survived at least three years compared to 48% on placebo. The drug also reduced the risk of disease progression or death by 24%, with a median progression-free survival (PFS) of 16.6 months versus 9.2 months for placebo.

The trial results were consistent across various patient subgroups, and the safety profile of IMFINZI was manageable with no new safety signals. These findings were announced at the 2024 ASCO Annual Meeting, positioning IMFINZI as a potential new standard of care for LS-SCLC.

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ENHERTU® demonstrated a median progression-free survival (PFS) of 13.2 months in HR positive, HER2 low and ultralow metastatic breast cancer patients following one or more lines of endocrine therapy, as shown in the DESTINY-Breast06 trial. The results showed a 38% reduction in the risk of disease progression or death compared to chemotherapy, with a statistically significant improvement in PFS. The overall response rate (ORR) was 57.3% with ENHERTU versus 31.2% with chemotherapy. These findings suggest that ENHERTU could become a new standard of care for this patient group. The trial also highlighted the safety profile of ENHERTU, which was consistent with previous trials.

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ENHERTU® (fam-trastuzumab deruxtecan-nxki), developed by AstraZeneca and Daiichi Sankyo, has shown promising results in the DESTINY-Breast06 Phase III trial for HR-positive, HER2-low and HER2-ultralow metastatic breast cancer. The trial indicated a median progression-free survival (PFS) of 13.2 months versus 8.1 months for chemotherapy, reducing the risk of disease progression or death by 38% (HR 0.62; 95% CI: 0.51-0.74; p<0.0001). Data also confirmed a higher objective response rate of 57.3% for ENHERTU compared to 31.2% with chemotherapy. No new safety concerns emerged, but interstitial lung disease was noted in 11.3% of patients. Additional data from DESTINY-Breast03 and DESTINY-Breast07 reinforce ENHERTU's potential as a standard treatment in earlier lines for HER2-positive breast cancer.

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FAQ

What is AstraZeneca PLC?

AstraZeneca PLC is a British-Swedish multinational pharmaceutical and biotechnology company formed in 1999 through the merger of Astra AB of Sweden and Zeneca Group PLC of the UK. It is headquartered in Cambridge, England.

What therapeutic areas does AstraZeneca focus on?

AstraZeneca’s product portfolio includes drugs across several therapeutic areas such as gastrointestinal, diabetes, cardiovascular, respiratory, oncology, immunology, and rare diseases.

Where does AstraZeneca generate most of its revenue?

A significant portion of AstraZeneca’s revenue comes from international markets, with the United States accounting for nearly one-third of its sales.

What is the recent collaboration between AstraZeneca and Nona Biosciences about?

AstraZeneca and Nona Biosciences have entered into a global license agreement to develop preclinical monoclonal antibodies aimed at creating targeted therapies in oncology.

What is C-CAR031?

C-CAR031 is a GPC3-targeted CAR-T therapy developed by AstraZeneca and AbelZeta Pharma for treating hepatocellular carcinoma (HCC). Initial clinical results have shown promising safety and efficacy data.

What is rilvegostomig?

Rilvegostomig is a PD-1/TIGIT bispecific antibody developed by AstraZeneca in collaboration with Compugen Ltd. It is currently in Phase 3 trials for non-small cell lung cancer and biliary tract cancer.

What are some of AstraZeneca’s key recent achievements?

Recent achievements include a global license agreement with Nona Biosciences for oncology therapies, collaboration with AbelZeta Pharma on C-CAR031, and partnership with Compugen Ltd. for developing rilvegostomig.

Where is AstraZeneca headquartered?

AstraZeneca is headquartered at the Cambridge Biomedical Campus in Cambridge, England.

When was AstraZeneca formed?

AstraZeneca was formed in 1999 through the merger of Astra AB of Sweden and Zeneca Group PLC of the UK.

What is the focus of AstraZeneca’s research and development?

AstraZeneca focuses on research and development in pharmaceuticals and biotechnology, particularly in creating treatments for various major therapeutic areas including cancer, respiratory diseases, cardiovascular conditions, and more.

AstraZeneca PLC

Nasdaq:AZN

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246.77B
1.54B
0.01%
16.8%
0.25%
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