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.
AstraZeneca showcased 47 abstracts at the 64th American Society of Hematology (ASH) Annual Meeting, emphasizing the efficacy and safety of its hematology portfolio, notably CALQUENCE and new pipeline drugs like TNB-486 (AZD0486). Key data included long-term results and early-stage trials across various blood cancers. CALQUENCE demonstrated a consistent safety profile in chronic lymphocytic leukemia (CLL), while TNB-486 showed potential in relapsed B-cell non-Hodgkin lymphoma. Research on rare diseases was also highlighted, aiming to improve diagnosis and treatment.
AstraZeneca (AZN) and National Resilience, Inc. announced a long-term partnership for biomanufacturing. Resilience will acquire AstraZeneca's facility in West Chester, Ohio, transforming it into a global center for drug product manufacturing. This multi-year supply agreement allows AstraZeneca strategic access to Resilience's manufacturing capabilities. The facility, spanning 580,000 square feet, will enhance the production of various medicines and supports Resilience's mission to ensure broad access to complex treatments, while also retaining over 500 jobs at the site.
AstraZeneca announces strong clinical data to be presented at the 2022 San Antonio Breast Cancer Symposium. The company will showcase its advancements with 12 medicines across 55 presentations, focusing on innovative treatments like capivasertib, an AKT inhibitor, and camizestrant, a next-generation oral SERD. Significant trial results from CAPItello-291 and SERENA-2 demonstrate potential improvements in treatment for HR-positive advanced breast cancer. Additionally, new data on ENHERTU® and datopotamab deruxtecan emphasize AstraZeneca’s commitment to personalized breast cancer therapies.
Alexion, AstraZeneca Rare Disease has completed its acquisition of LogicBio Therapeutics, Inc. (NASDAQ: LOGC), enhancing its capability in genomic medicine. This strategic move leverages LogicBio's unique technology and experienced R&D team, facilitating growth in rare disease therapeutics. The acquisition was finalized on November 16, 2022, following a successful tender offer. LogicBio shareholders will receive $2.07 per share. Frederic Chereau, the CEO of LogicBio, will transition to a senior role within Alexion.
Daiichi Sankyo and AstraZeneca announced that the European Medicines Agency's CHMP has recommended approval of ENHERTU for treating advanced HER2 positive gastric cancer. This approval is based on positive results from the DESTINY-Gastric02 and DESTINY-Gastric01 trials, showing improved overall survival and response rates over chemotherapy. ENHERTU demonstrated a confirmed objective response rate of 41.8% in DESTINY-Gastric02 and 51.3% in DESTINY-Gastric01, with median overall survival reaching 12.1 months and 12.5 months, respectively. The European Commission will review this recommendation for final approval.
AstraZeneca's IMFINZI and IMJUDO combination therapy has received FDA approval for treating Stage IV non-small cell lung cancer (NSCLC) based on findings from the POSEIDON Phase III trial. This combination resulted in a 23% reduction in mortality risk and a 28% decrease in disease progression, with 33% of patients alive after two years compared to 22% in chemotherapy alone. The treatment shows potential for addressing unmet needs in a challenging patient population. Regulatory applications are pending in Europe and Japan, reflecting AstraZeneca's commitment to cancer treatment advancements.
AstraZeneca's EVUSHELD has been recognized by TIME as one of the Best Inventions of 2022. This marks it as the first long-acting monoclonal antibody authorized in the US for COVID-19 prevention in immunocompromised individuals. The recognition underscores the therapeutic's significant impact on vulnerable populations during the pandemic. EVUSHELD is authorized in multiple regions, including the US and EU, for individuals whose immune systems are compromised due to various medical conditions. The company remains committed to advancing immune therapies for these groups.
AstraZeneca's PT027 (albuterol/budesonide) received a favorable recommendation from the FDA's Pulmonary-Allergy Drugs Advisory Committee for treating asthma in adults (16-1 vote) but was not recommended for adolescents (9-8) or children (16-1). PT027, a first-in-class rescue medication, aims to reduce severe asthma exacerbations and improve overall management by addressing inflammation. The NDA, based on Phase III trial results, was previously accepted in early 2022 with a PDUFA date set for 2023. This treatment could significantly impact asthma care.
Invitae (NYSE: NVTA) has partnered with AstraZeneca to utilize its Ciitizen data platform for enhancing research on cholangiocarcinoma, a rare bile duct cancer. Through this collaboration, patient-consented data from the Cholangiocarcinoma Foundation will be leveraged to improve treatment outcomes. The study will track patients on AstraZeneca’s TOPAZ-1 regimen over three years to assess long-term efficacy and tolerability. This initiative aims to bridge gaps in clinical research for rare diseases by incorporating real-world insights into treatment strategies.
ULTOMIRIS has shown promising results in the Phase III CHAMPION-NMOSD trial, demonstrating a 98.6% reduction in relapse risk for AQP4 antibody-positive NMOSD patients compared to placebo. With a median treatment duration of 73 weeks, 100% of ULTOMIRIS patients remained relapse-free at 48 weeks, highlighting its effectiveness. Additionally, the treatment exhibited a lower rate of clinically significant worsening in patient mobility, assessed via the Hauser Ambulatory Index. The drug, developed by Alexion, is currently under regulatory review in the US, EU, and Japan.