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AstraZeneca PLC (AZN) is a global biopharmaceutical leader focused on oncology, cardiovascular, respiratory, and immunology research. This centralized hub provides verified company announcements, press releases, and market-moving developments from authoritative sources.
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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.
AstraZeneca announced positive results from the SERENA-2 Phase II trial for its next-generation oral selective estrogen receptor degrader, camizestrant. The trial demonstrated a statistically significant progression-free survival benefit in postmenopausal patients with ER-positive breast cancer at both 75mg and 150mg doses compared to FASLODEX. Camizestrant was well tolerated with no new safety signals. AstraZeneca is advancing a Phase III program for camizestrant, following a comprehensive clinical development strategy aimed at improving treatment options for advanced breast cancer.
AstraZeneca announced positive results from the CAPItello-291 Phase III trial, demonstrating that capivasertib combined with FASLODEX significantly improves progression-free survival (PFS) in patients with HR-positive, HER2-low or negative metastatic breast cancer. This offers new hope for patients experiencing resistance to current therapies. The trial met its primary endpoints and safety profiles were consistent with previous studies. Although overall survival data is still immature, initial results are promising.
AstraZeneca has received FDA approval for IMJUDO (tremelimumab) in combination with IMFINZI (durvalumab) to treat adults with unresectable hepatocellular carcinoma (HCC). This combination therapy demonstrated a 22% reduced risk of death compared to sorafenib, based on Phase III HIMALAYA trial results. The novel STRIDE regimen includes a single dose of IMJUDO followed by IMFINZI every four weeks. An estimated 31% of patients treated with the combination were alive after three years. The approval underscores AstraZeneca's commitment to advancing cancer treatment options.
AstraZeneca, in collaboration with Scientific American Custom Media, unveiled the winners of the 2022 Cancer Community Awards (C2 Awards), recognizing significant contributions to equitable cancer care. Awardees included Sparrow’s Nest for improving care experiences, Charles R. Rogers for addressing health disparities, and the Center for H.O.P.E for enhancing access to screenings. Each winner received a $50,000 donation for their non-profit organizations, showcasing the importance of community partnerships in redefining cancer treatment.
