Astrazeneca Plc - AZN STOCK NEWS

AstraZeneca has received Fast Track Designation from the FDA for LOKELMA (sodium zirconium cyclosilicate) to address cardiovascular outcomes related to arrhythmia in patients on chronic hemodialysis with recurrent hyperkalemia. This decision underlines the potential of LOKELMA to mitigate life-threatening cardiovascular risks in this population, which is currently under investigation in the Phase III DIALIZE-Outcomes trial. Hyperkalemia significantly impacts 24% to 48% of patients with chronic kidney disease, representing a crucial unmet medical need. Results from the trial are expected in 2024.

AstraZeneca presented promising new data on CALQUENCE at the 63rd American Society of Hematology Annual Meeting, focusing on chronic lymphocytic leukemia (CLL). New findings include a three-year follow-up from the ASCEND trial demonstrating CALQUENCE's durable efficacy compared to standards of care. Additionally, a new tablet formulation aims to expand patient eligibility. The emerging pipeline shows potential in developing innovative therapies for hard-to-treat blood cancers, enhancing long-term patient care.

Integral Molecular announced an exclusive worldwide antibody license agreement with AstraZeneca (LSE/STO/Nasdaq: AZN) to develop cancer therapeutics. Integral Molecular will supply highly specific monoclonal antibodies, while AstraZeneca will handle all research and commercial activities. This collaboration aims to enhance personalized cancer treatments and improve patient outcomes. The antibodies were discovered using Integral Molecular's advanced technology platforms, ensuring remarkable specificity and efficacy against challenging cancer targets.

Daiichi Sankyo announced that the European Medicines Agency (EMA) has validated the Type II Variation Application for trastuzumab deruxtecan, a HER2 directed antibody drug conjugate developed with AstraZeneca (AZN). This application aims to treat adult patients with advanced or metastatic HER2 positive gastric cancer, following a prior anti-HER2 regimen. The validation signals the start of a scientific review process by the EMA’s Committee for Medicinal Products for Human Use (CHMP).

New analyses from the TULIP Phase III clinical trials demonstrate that SAPHNELO (anifrolumab), a type I interferon antagonist, significantly reduces systemic lupus erythematosus (SLE) disease activity compared to standard therapy alone. Presented at ACR Convergence 2021, the data indicate consistent efficacy regardless of disease duration or prior treatments. Notably, SAPHNELO showed a 14.4% improvement over standard therapy in recently diagnosed patients, and 17.1% in those with established disease, along with better response rates across various baseline therapies.

AstraZeneca has launched the ACT on Health Equity: Community Solutions Challenge, contributing funds to 30 nonprofit organizations across the US. This initiative aims to enhance health equity by supporting underserved populations. Over 1,350 applications were received in its inaugural year, reflecting a wide interest in community health and youth education. The challenge aligns with AstraZeneca's long-term commitment to health equity and is supported by experts in the field. Programs funded will employ community-based approaches to improve local health outcomes.

Positive Results from TOPAZ-1 Trial: IMFINZI combined with chemotherapy shows significant overall survival benefits for advanced biliary tract cancer (BTC) patients compared to chemotherapy alone.

The Independent Data Monitoring Committee confirmed the trial met its primary endpoint, demonstrating improved progression-free survival and overall response rate. IMFINZI's safety profile aligns with standard chemotherapy, with no increase in adverse event discontinuation rates.

With about 210,000 BTC cases annually worldwide, these findings mark a pivotal advancement for a cancer with limited treatment options.

Daiichi Sankyo and AstraZeneca have entered into a collaboration with Merck to advance the TROPION-Lung08 phase 3 trial. This trial will evaluate the TROP2 directed ADC, datopotamab deruxtecan, in combination with Merck's KEYTRUDA in treatment-naïve patients with PD-L1 high advanced or metastatic non-small cell lung cancer (NSCLC). The trial aims to improve outcomes compared to KEYTRUDA alone, addressing the significant patient population that does not respond to current therapies. Approximately 740 patients are expected to be enrolled across multiple regions.

AstraZeneca, alongside Scientific American Custom Media, announced the winners of the 2021 Cancer Community Awards (C2 Awards). This year, a new Catalyst for Equity Award was introduced to support health equity for disadvantaged communities. Over 100 nominations were received from 28 states. Winners received a $50,000 donation for a nonprofit organization. The awards recognize individuals and organizations making significant contributions in oncology, aiming to enhance cancer care and ensure equitable access to treatments.