Astrazeneca Plc Stock Price, News & Analysis

Positive results from the Phase III MANDALA and DENALI trials for PT027, a fixed-dose inhaler combining albuterol and budesonide, were announced. PT027 significantly reduced the risk of severe asthma exacerbations compared to albuterol and improved lung function in patients with mild to moderate asthma. The MANDALA trial involved 3,132 patients, while DENALI included 1,001 participants. Both trials met their primary endpoints, indicating PT027's potential as a first-in-class treatment for asthma. AstraZeneca and Avillion are advancing this promising new therapy.

AstraZeneca announced that FLUMIST® QUADRIVALENT, the only FDA-approved nasal-spray flu vaccine, is now available in the US for the 2021-2022 influenza season. Indicated for ages 2 to 49, its supply is expected to bulk by mid-September. The CDC emphasizes flu vaccination as crucial to reduce healthcare burdens. FLUMIST is expected to be preferred by patients due to its needle-free delivery method. Common side effects include runny nose, sore throat, and fever. The vaccine is covered by most health plans.

The PROVENT Phase III trial results for AstraZeneca's AZD7442 show a significant efficacy in reducing symptomatic COVID-19 cases by 77% compared to placebo. Among 5,197 participants, there were only 25 cases of symptomatic COVID-19 in the AZD7442 group, with no severe cases or related deaths reported. AZD7442, a long-acting antibody combination delivered intramuscularly, is proposed for individuals unable to respond to vaccines. The data is set for regulatory submission for potential emergency use authorization. Further results from the ongoing clinical trial program are expected later this year.

ENHERTU® (fam-trastuzumab deruxtecan-nxki), developed by AstraZeneca and Daiichi Sankyo, has demonstrated superiority over T-DM1 in the DESTINY-Breast03 Phase III trial for HER2-positive metastatic breast cancer. An interim analysis highlighted a significant improvement in progression-free survival (PFS) for patients treated with ENHERTU. Overall survival data is still maturing, but ENHERTU's safety profile aligns with previous studies, showing no new concerns. Regulatory submissions are planned based on these findings, aiming to establish ENHERTU as a new standard of care.

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.