Astrazeneca Plc Stock Price, News & Analysis

AstraZeneca's SAPHNELO™ (anifrolumab-fnia) has received FDA approval for treating adult patients with moderate to severe systemic lupus erythematosus (SLE) on standard therapy. This landmark approval is based on significant clinical trial data showing improved disease activity and reduced corticosteroid use. SAPHNELO is the first treatment for SLE approved in over a decade and utilizes a novel mechanism targeting type I interferon pathways. Common adverse reactions include respiratory infections and herpes zoster. The drug is not recommended for certain severe lupus conditions.

AstraZeneca's BYDUREON BCise (exenatide extended-release) has received FDA approval for treating type 2 diabetes in pediatric patients aged 10-17, marking the first such approval for a once-weekly GLP-1 RA in this demographic. The decision is supported by positive Phase III trial results, which demonstrated significant improvements in glycemic control. This new option complements the current treatments of metformin and liraglutide for adolescents with type 2 diabetes, addressing a growing health concern as childhood diabetes rates rise, particularly in the U.S.

Aridis Pharmaceuticals (Nasdaq: ARDS) has secured an exclusive worldwide license from AstraZeneca (LSE/STO/Nasdaq: AZN) for suvratoxumab, a monoclonal antibody candidate aimed at preventing pneumonia. This Phase 3-ready candidate follows positive Phase 2 results, showing a 47% reduction in pneumonia among S. aureus-colonized mechanically ventilated patients. Aridis will receive up to €25 million (~$30 million) in funding from the EU for the Phase 3 trial, while AstraZeneca will obtain an $11 million upfront payment and potential milestones worth $115 million.

AstraZeneca’s Biologics License Application for tezepelumab has been accepted for Priority Review by the FDA for treating asthma. Developed in collaboration with Amgen, tezepelumab shows potential to transform asthma treatment, having demonstrated significant reductions in exacerbations in clinical trials. The NAVIGATOR Phase III trial highlighted a 56% reduction in annual exacerbation rates compared to placebo. The FDA action date is set for Q1 2022, and tezepelumab previously received Breakthrough Therapy Designation for patients without an eosinophilic phenotype.

AstraZeneca announced positive results from a Phase III trial (NCT01554618) evaluating exenatide extended-release 2mg in adolescents aged 10-17 with type 2 diabetes (T2D). The study demonstrated a significant reduction in HbA1c levels compared to placebo, achieving its primary endpoint with a LS mean difference of -0.85% (P=0.012). The treatment was generally well tolerated, with adverse events comparable to adults. This is the first trial of a GLP-1 receptor agonist for this age group, and AstraZeneca has filed for FDA priority review for adolescent use.

PathAI announced its participation in the ASCO Virtual Scientific Program 2021, presenting new data on a quality control tool for HER2 testing in digital pathology images. The presentation includes the poster Machine learning models to quantify HER2 for real-time tissue image analysis in prospective clinical trials (Abstract #3061). Together with AstraZeneca (AZN) and Daiichi Sankyo, PathAI developed ML-based models demonstrating high accuracy in HER2 scoring, consistent with ASCO/CAP guidelines, enhancing testing quality in breast cancer clinical trials.

AstraZeneca's CALQUENCE (acalabrutinib) has shown promising results in the ELEVATE-RR Phase III trial, demonstrating non-inferior progression-free survival (PFS) compared to ibrutinib in chronic lymphocytic leukemia (CLL) patients. Median PFS reached 38.4 months for both arms, with CALQUENCE exhibiting a significantly reduced incidence of atrial fibrillation (9.4% versus 16.0%). Additionally, updated ELEVATE-TN trial results indicated a strong PFS benefit for CALQUENCE in previously untreated patients, achieving 87% PFS at 48 months when combined with obinutuzumab.

AstraZeneca’s IMFINZI® (durvalumab) showed significant five-year overall survival (OS) and progression-free survival (PFS) benefits in the updated PACIFIC Phase III trial for patients with unresectable Stage III non-small cell lung cancer (NSCLC) post-chemoradiation therapy. The estimated five-year OS rate was 42.9% for IMFINZI-treated patients versus 33.4% for placebo. Notably, 33.1% of IMFINZI patients had not progressed, compared to 19% for placebo. IMFINZI represents a major advancement, marking the first new treatment available in decades for this patient group.

AstraZeneca and Merck have announced significant results from the OlympiA Phase III trial, demonstrating that LYNPARZA® (olaparib) significantly improves invasive disease-free survival (iDFS) in patients with germline BRCA-mutated, HER2-negative early breast cancer compared to placebo. Data presented at ASCO 2021 shows a 42% reduction in the risk of invasive breast cancer recurrence, with three-year iDFS rates at 85.9% for LYNPARZA versus 77.1% for placebo. The trial continues to monitor overall survival, with regulatory discussions ongoing to expedite treatment access for eligible patients.