Welcome to our dedicated page for AstraZeneca news (Ticker: AZN), a resource for investors and traders seeking the latest updates and insights on AstraZeneca stock.
AstraZeneca PLC develops and commercializes prescription medicines across oncology, rare diseases, and BioPharmaceuticals, including cardiovascular, renal and metabolism, respiratory, and immunology. News about AZN commonly covers clinical-trial results, FDA and advisory-committee actions, product approvals, and updates to marketed medicines such as TRUQAP, BREZTRI, SAPHNELO, IMFINZI, IMJUDO, and ULTOMIRIS.
Company updates also address quarterly revenue and earnings trends, alliance and collaboration revenue, licensing transactions for pipeline assets, and governance changes. Recurring development themes include targeted oncology, COPD, asthma, systemic lupus erythematosus, liver cancer, prostate cancer, and rare or immune-mediated diseases.
Keymed Biosciences Inc. and Lepu Biopharma Co., Ltd have entered into a global exclusive license agreement with AstraZeneca (AZN) for CMG901, a potential first-in-class antibody drug conjugate targeting Claudin 18.2. AstraZeneca will oversee research, development, manufacturing, and commercialization of CMG901, which is currently in Phase I trials for Claudin 18.2-positive solid tumors. The agreement provides Keymed with an upfront payment of $63 million and potential milestone payments up to $1.1 billion, along with low double-digit tiered royalties. Closing is anticipated in the first half of 2023, pending regulatory approvals.
Results from the PROpel Phase III trial for metastatic castration-resistant prostate cancer (mCRPC) indicate that the combination of LYNPARZA® (olaparib) and abiraterone offers a median overall survival (OS) of 42.1 months, compared to 34.7 months for abiraterone alone. This 7.4-month increase, though not statistically significant (HR 0.81), underscores the potential of the combination therapy. The safety profile remains consistent with previous studies, showing no new long-term safety issues. LYNPARZA was approved in the EU in December 2022 for mCRPC patients, highlighting its importance in addressing a critical treatment gap in prostate cancer.
SOPHiA GENETICS (Nasdaq: SOPH) is partnering with AstraZeneca (Nasdaq: AZN) to enhance precision oncology through its SOPHiA DDM™ platform and multimodal technology. This collaboration aims to improve early patient identification, optimize clinical development, and accelerate the use of innovative treatments. The partnership will integrate various data modalities, including radiomics, molecular data, and clinical information, to provide better insights for treatment decisions. Additionally, SOPHiA is conducting its own DEEP-Lung-IV clinical study to identify predictive signatures for lung cancer immunotherapy response.
AstraZeneca and Amgen's TEZSPIRE® (tezepelumab-ekko) has received FDA approval for self-administration via a pre-filled pen for patients aged 12 and older with severe asthma. This makes TEZSPIRE the first biologic treatment for severe asthma with no phenotype or biomarker limitations. The approval comes from extensive clinical trials, showing high success rates in administering the drug at home or in clinics. TEZSPIRE is also approved in the EU and Japan, with ongoing reviews in other regions. The collaboration aims to enhance treatment options for patients suffering from this complex condition, addressing significant unmet needs.
Daiichi Sankyo announced the dosing of the first patient in the global, randomized TROPION-Lung07 phase 3 trial, evaluating datopotamab deruxtecan in combination with pembrolizumab, with or without chemotherapy, for patients with untreated non-small cell lung cancer (NSCLC). This trial targets patients with PD-L1 expression less than 50% and aims to improve treatment outcomes for a patient group that faces significant disease progression with current therapies. The study will enroll approximately 975 patients and assess primary endpoints such as progression-free survival (PFS) and overall survival.
Daiichi Sankyo and AstraZeneca have received EU approval for ENHERTU (trastuzumab deruxtecan) to treat adults with HER2 low (IHC 1+ or IHC 2+/ISH-) metastatic breast cancer. The therapy significantly reduced disease progression or death risk by 50% and increased median overall survival by over six months compared to chemotherapy. Approval is based on the pivotal DESTINY-Breast04 trial results, reinforcing ENHERTU as a potential new standard of care. Following this, AstraZeneca is due to pay $150 million to Daiichi Sankyo as a milestone payment.
AstraZeneca has initiated a tender offer to acquire all outstanding shares of CinCor Pharma for $26 per share in cash, plus a contingent value right of $10 per share linked to a regulatory submission for a baxdrostat product. Announced on 9 January 2023, the offer aims to close in Q1 2023, pending conditions including the tender of more than 50% of CinCor's shares. CinCor's board recommends stockholders accept the offer. The tender offer expires on 23 February 2023. The announcement highlights AstraZeneca's strategy in cardiovascular, renal, and metabolic diseases.
AIRSUPRA™ (albuterol/budesonide) has received FDA approval in the US for the as-needed treatment of asthma in adults, marking it as the first rescue medication addressing both bronchoconstriction and inflammation. The approval followed positive outcomes from the MANDALA and DENALI Phase III trials, with results showing a 27% reduction in severe exacerbation risk compared to standard albuterol. AIRSUPRA aims to tackle over 10 million annual asthma exacerbations in the US, potentially alleviating significant healthcare costs associated with uncontrolled asthma. The safety profile aligns with known component effects.
Tempus has announced a prospective study named Sculptor in collaboration with AstraZeneca (AZN) to identify biomarkers for small cell lung cancer (SCLC). The study, currently open for enrollment, aims to enhance therapeutic targeting for this aggressive cancer, which affects around 13% of lung cancer patients in the U.S. The initiative leverages Tempus' molecular profiling capabilities and aims to expand its dataset nationally through the TIME Trial Network, enhancing precision medicine approaches for SCLC treatment.
Genomic Vision has introduced its AI-powered software, FiberSmart®, successfully tested by AstraZeneca (AZN) and the Fritz Lipmann Institute in Germany. This innovative software automates genomic analyses, focusing on the Replication Combing Assay (RCA), enhancing accuracy by threefold and speeding up processes by tenfold compared to prior solutions. The platform aims to provide a seamless user experience, optimizing the analysis of DNA replication kinetics. The launch is set for the coming weeks, promising significant advancements in genomic research.