AstraZeneca PLC - AZN STOCK NEWS

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.

AstraZeneca's TAGRISSO® (osimertinib) has received acceptance for its supplemental New Drug Application and Priority Review by the FDA for treating early-stage EGFR-mutated non-small cell lung cancer post-surgery. The FDA's expedited review highlights TAGRISSO's potential to significantly improve disease-free survival rates, particularly in patients with Stage II and IIIA disease, based on results from the ADAURA Phase III trial. Approximately 30% of NSCLC patients could benefit from this treatment, as many experience recurrence despite surgery.

AstraZeneca's FARXIGA^® (dapagliflozin) has received Breakthrough Therapy Designation (BTD) from the FDA for treating chronic kidney disease (CKD) in patients with and without type 2 diabetes. This designation is aimed at accelerating the development of treatments for serious conditions with unmet medical needs. Clinical trial results showed that FARXIGA reduced the risk of worsening renal function or death from cardiovascular causes by 39%. The drug is crucial as approximately 37 million people in the US have CKD.