Astrazeneca Plc Stock Price, News & Analysis

AstraZeneca is set to present new findings on breast cancer therapies at the 2020 San Antonio Breast Cancer Symposium (SABCS) from December 8-11. Key highlights include updated data from the DESTINY-Breast01 Phase II trial, showcasing ENHERTU's efficacy in HER2-positive metastatic breast cancer, and promising results from the SERENA-1 Phase I trial evaluating AZD9833 in HR-positive, HER2-negative advanced breast cancer. AstraZeneca emphasizes its commitment to improving outcomes for breast cancer patients through innovative treatments and collaborations.

AstraZeneca's IMFINZI® (durvalumab) has received FDA approval for a new 1,500mg fixed dosing option every four weeks for patients with unresectable Stage III non-small cell lung cancer (NSCLC) post-chemoradiation and previously treated advanced bladder cancer. This alternative to the current weight-based dosing aims to improve patient convenience and reduce healthcare visits. This decision follows the FDA's Priority Review status and is based on data from pivotal clinical trials, including the PACIFIC and CASPIAN studies.

AstraZeneca will showcase new research at the 62nd ASH Annual Meeting from December 5-8, 2020, focusing on blood cancers. The Company is presenting 27 abstracts related to five medicines, including CALQUENCE. Highlights include a pooled analysis of CALQUENCE’s cardiovascular safety in CLL, promising follow-up data in MCL, and findings on roxadustat for various anemia conditions. The data aim to address unmet needs in hematology and demonstrate AstraZeneca's commitment to improving treatments for patients with hematologic malignancies.

A recent study highlights that 81.1% of patients with NYHA class II-IV heart failure with reduced ejection fraction (HFrEF) may qualify for treatment with FARXIGA (dapagliflozin). This data was presented at the AHA’s Scientific Sessions 2020, based on over 150,000 patient records from U.S. hospitals. FARXIGA is FDA-approved to lower cardiovascular death and hospitalization risks in adults with HFrEF. The study underscores the urgent need for clinical practice to adopt this treatment, ultimately aiming to fill gaps in care for heart failure patients.

AstraZeneca and Amgen announced positive results from the NAVIGATOR Phase III trial of tezepelumab for severe, uncontrolled asthma. The trial met its primary endpoint with a significant reduction in the annualized asthma exacerbation rate (AAER) over 52 weeks compared to placebo. Tezepelumab was well tolerated and showed efficacy in patients with low eosinophil counts. This promising data supports the FDA's Breakthrough Therapy Designation for patients without an eosinophilic phenotype. Severe asthma affects approximately 34 million people globally.

AstraZeneca announced that its drug BRILINTA (ticagrelor) has been approved by the FDA to reduce the risk of stroke in patients with acute ischemic stroke or high-risk transient ischemic attack (TIA). This decision is based on the positive results from the THALES Phase III trial, which demonstrated that BRILINTA combined with aspirin significantly decreased the rate of stroke and death. The trial showed a statistically significant reduction of 17% in the primary composite endpoint. BRILINTA is already approved in over 110 countries for various cardiovascular conditions.

AstraZeneca and Daiichi Sankyo's ENHERTU® has received acceptance for its supplemental Biologics License Application and has been granted Priority Review by the FDA for treating HER2-positive metastatic gastric or gastroesophageal junction adenocarcinoma. The FDA's action date is set for Q1 2021. This reflects critical advancements in treatment options, as current approved HER2-directed therapies are lacking for patients with poor prognosis after initial anti-HER2 treatment. The sBLA is based on the DESTINY-Gastric01 trial, showing significant improvements in patient outcomes.

AstraZeneca announced new findings from the DAPA-CKD Phase III trial indicating that FARXIGA (dapagliflozin) significantly reduces the risk of worsening kidney function and cardiovascular or renal death in patients with chronic kidney disease (CKD), regardless of its cause. The study showed a relative risk reduction of 37% for diabetic kidney disease and 25% for hypertension, among others. FARXIGA also demonstrated a decrease in all-cause mortality. These results support FARXIGA's potential to change CKD treatment standards. The data were presented at the American Society of Nephrology Kidney Week 2020.

AstraZeneca, alongside Scientific American Custom Media, revealed the winners of the second annual Cancer Community (C2) Awards, celebrating grassroots organizations enhancing cancer care. This year’s event received nominations from 31 states. The C2 Awards feature four categories, awarding $50,000 to each winner to support non-profits in the cancer community. Significant honorees include Lynette Bonar, who opened the first cancer facility on a Navajo reservation, and Dr. Lincoln D. Nadauld, recognized for his advancements in precision medicine that doubled patient survival rates.