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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.
Eplontersen has received Orphan Drug Designation from the FDA for treating transthyretin-mediated amyloidosis, a serious progressive condition. Also known as IONIS-TTR-LRx, Eplontersen is undergoing Phase III trials for ATTR-CM and ATTR-PN. The FDA grants this status to drugs for rare diseases affecting less than 200,000 people in the U.S. AstraZeneca and Ionis Pharmaceuticals will jointly develop Eplontersen, with regulatory approval expected for hereditary ATTR-PN by late 2022, signaling promising advancements in treatment options for patients.
AstraZeneca announced positive results from the HIMALAYA Phase III trial, demonstrating that a single dose of tremelimumab combined with IMFINZI reduced the risk of death by 22% in patients with unresectable liver cancer compared to sorafenib. The median overall survival (OS) was 16.4 months for the STRIDE regimen versus 13.8 months for sorafenib. The trial showed improved safety profiles, with fewer severe liver toxicities and treatment discontinuations. Findings will be presented at the ASCO Gastrointestinal Cancers Symposium on January 21, 2022.
AstraZeneca announced positive results from the TOPAZ-1 Phase III trial, revealing that IMFINZI® (durvalumab) combined with chemotherapy significantly improves overall survival and progression-free survival for patients with advanced biliary tract cancer compared to chemotherapy alone. The trial showed a 20% reduction in the risk of death and a median overall survival of 12.8 months versus 11.5 months for chemotherapy. The combination also resulted in a 25% reduction in disease progression risk. This promising data will be presented at the ASCO Gastrointestinal Cancers Symposium on January 21, 2022.
AstraZeneca and Daiichi Sankyo's Enhertu has received acceptance for a supplemental Biologics License Application in the US for treating advanced HER2-positive breast cancer after previous anti-HER2 regimens. The FDA has granted it Priority Review under its Real-Time Oncology Review and Project Orbis initiatives, aimed at expediting effective cancer treatments. Enhertu demonstrated a 72% reduction in disease progression risk versus T-DM1 in trials, further emphasizing the need for more treatment options in this area.
Daiichi Sankyo and AstraZeneca announced the FDA's acceptance of the supplemental Biologics License Application (sBLA) for ENHERTU, designed for adult patients with unresectable or metastatic HER2 positive breast cancer. The application has received Priority Review and is part of the FDA's Real-Time Oncology Review and Project Orbis initiatives. ENHERTU showed a 72% reduction in disease progression or death versus T-DM1 in the DESTINY-Breast03 trial, with notable improvements in overall survival and objective response rates. The FDA action date is in Q2 2022.
AstraZeneca presented promising data on cancer treatments at the 2022 ASCO GI and GU Symposia, highlighting the efficacy of IMFINZI and LYNPARZA in liver, biliary tract, and prostate cancers. IMFINZI demonstrated a significant overall survival benefit in unresectable liver cancer with a novel dual immunotherapy regimen. In prostate cancer, LYNPARZA showcased its first clinical benefits combined with abiraterone. AstraZeneca aims to transform cancer care with innovative therapies and collaborations, emphasizing a commitment to improving patient outcomes.
AstraZeneca and Amgen announced the availability of TEZSPIRE™ (tezepelumab-ekko) for severe asthma patients in the US, following FDA approval on December 17, 2021. This biologic treatment uniquely targets thymic stromal lymphopoietin (TSLP) and has no phenotype or biomarker restrictions, addressing a wide range of severe asthma patients. Clinical trials demonstrated significant reductions in asthma exacerbations. Common side effects include pharyngitis and arthralgia. Both companies aim to ensure affordable access through their Tezspire Together Program and patient assistance initiatives.
Scorpion Therapeutics has partnered with AstraZeneca (AZN) to develop precision medicines targeting hard-to-reach cancer proteins known as transcription factors. This collaboration aims to enhance cancer treatment options by leveraging Scorpion's advanced drug discovery platform.
Scorpion will receive an upfront payment of
Fusion Pharmaceuticals (FUSN) announced the nomination of its first targeted alpha therapy (TAT) candidate in collaboration with AstraZeneca (AZN). This candidate utilizes Fusion's Fast-Clear™ linker technology and involves an actinium-225 radiolabeled bispecific antibody. The Phase 1 study is set to proceed following IND-enabling studies, with both companies sharing development costs. Fusion is also advancing its lead program, FPI-1434, targeting IGF-1R in Phase 1 trials, and has a pipeline that includes FPI-1966 and FPI-2059. The collaboration aims to explore up to three TATs and five combination therapies.
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