Astrazeneca Plc - AZN STOCK NEWS

AstraZeneca's FARXIGA® (dapagliflozin) has received FDA approval to lower the risk of kidney decline, end-stage kidney disease, cardiovascular death, and heart failure hospitalization in adults with chronic kidney disease (CKD). This approval is based on results from the DAPA-CKD Phase III trial, showing a 39% reduction in the risk of worsening renal function compared to placebo. FARXIGA is now the first SGLT2 inhibitor approved for CKD treatment irrespective of diabetes status, marking a significant advancement in this field.

AstraZeneca has partnered with Massachusetts General Hospital to develop digital health solutions focused on chronic illness management. This collaboration, sparked by the COVID-19 pandemic, aims to create patient-centric digital tools, starting with studies on heart failure and asthma using the AMAZE disease management platform. The goal is to enhance patient engagement and clinical outcomes while reducing costs. Following initial studies, there are plans to expand the AMAZE platform to other chronic diseases across the Mass General Brigham system.

The Phase III trial results of AZD1222 demonstrate a vaccine efficacy of 76% in preventing symptomatic COVID-19 among 32,449 participants. The analysis showed 100% efficacy in preventing severe cases, with all eight severe cases occurring in the placebo group. AstraZeneca plans to submit for Emergency Use Authorization to the FDA shortly. The vaccine, co-invented by the University of Oxford, has received support exceeding $1bn from BARDA and has been granted emergency use in over 70 countries.

AstraZeneca's US Phase III trial of AZD1222 shows 79% efficacy in preventing symptomatic COVID-19 and 100% efficacy against severe disease. The interim analysis involved 32,449 participants with 141 symptomatic cases. Notably, the vaccine demonstrated 80% efficacy in participants aged 65 and above. The data safety monitoring board reported no safety concerns, including no increased risk of thrombotic events. AstraZeneca is preparing to submit the data to the FDA for emergency use authorization and plans a broad rollout if approved.

AstraZeneca and Amgen's tezepelumab has shown significant results in the NAVIGATOR Phase III trial, with a 56% reduction in annualized asthma exacerbation rate (AAER) for severe asthma patients compared to placebo. Notably, tezepelumab was effective across various eosinophil counts, achieving a 41% reduction in patients with eosinophil counts <300 cells/μL. The trial demonstrated improvements in lung function, asthma control, and quality of life. Safety results were comparable to placebo, with common adverse events being mild.

AstraZeneca and Merck announced the OlympiA Phase III trial for LYNPARZA (olaparib) has progressed to early primary analysis after a recommendation from the Independent Data Monitoring Committee (IDMC). The trial demonstrated superior efficacy for LYNPARZA versus placebo in improving invasive disease-free survival (iDFS) for patients with germline BRCA-mutated high-risk HER2-negative early breast cancer. The IDMC raised no new safety concerns, and the trial continues to assess key secondary endpoints. This advancement may provide new options for high-risk breast cancer patients.

AliveCor has partnered with AstraZeneca (AZN) to develop innovative disease management solutions in cardiovascular, renal, and metabolism therapeutic areas. This collaboration will utilize AliveCor's potassium detection technology, which allows non-invasive measurement of potassium levels outside of traditional blood tests. The initiative aims to support nearly 30 million U.S. adults with chronic kidney disease, potentially improving patient outcomes and addressing high potassium risks associated with kidney disease.

AstraZeneca's TAGRISSO® (osimertinib) has demonstrated significant disease-free survival (DFS) benefits in the ADAURA Phase III trial for patients with EGFR-mutated non-small cell lung cancer (NSCLC). TAGRISSO reduced the risk of disease recurrence or death by 84% in patients previously treated with chemotherapy and by 77% in those untreated. The trial also showed consistent DFS benefits across disease stages. Following its recent US approval for adjuvant treatment, AstraZeneca aims to expand TAGRISSO's availability globally.

AstraZeneca announced positive results from the ELEVATE-RR Phase III trial of CALQUENCE^® (acalabrutinib) for high-risk chronic lymphocytic leukemia (CLL). The drug demonstrated non-inferior progression-free survival compared to ibrutinib, while showing significantly lower atrial fibrillation rates. With more than 40 months of follow-up, CALQUENCE maintained a favorable safety profile without compromising efficacy. The trial involved 533 patients, and results highlight CALQUENCE's potential in treating CLL, which affects many adults worldwide.