Astrazeneca Plc - AZN STOCK NEWS

AstraZeneca has received Orphan Drug Designation from the FDA for Tezepelumab to treat eosinophilic esophagitis (EoE), a rare inflammatory disease affecting the esophagus. This designation is crucial as it supports the development of therapies for diseases impacting fewer than 200,000 patients in the U.S. Currently, no FDA-approved treatments exist for EoE. Tezepelumab is also under Priority Review for asthma in the U.S., with decisions anticipated in early 2022. The collaboration between AstraZeneca and Amgen continues, enabling joint commercialization efforts.

AstraZeneca has filed for Emergency Use Authorization (EUA) with the US FDA for AZD7442, a long-acting antibody combination to prevent symptomatic COVID-19. The drug shows a 77% reduction in risk based on data from the PROVENT Phase III trial. This submission marks a significant step as AZD7442 could be the first long-acting antibody approved for COVID-19 prevention. The trial included participants with comorbidities, with over 75% at increased risk. AZD7442 leverages proprietary technology to enhance its durability, potentially offering up to 12 months of protection.

The FDA has granted ENHERTU Breakthrough Therapy Designation for treating adult patients with unresectable or metastatic HER2-positive breast cancer. This designation is based on the DESTINY-Breast03 trial, showing a 72% reduction in disease progression or death compared to T-DM1. ENHERTU now holds four BTDs, with the total patient survival rate at one year reaching 94.1%. The designation aims to expedite development for medicines addressing significant unmet medical needs. The ongoing comprehensive clinical program assesses ENHERTU across various HER2-targetable cancers.

Compugen Ltd. (NASDAQ: CGEN) announced a $6 million milestone payment from AstraZeneca (NASDAQ: AZN) following the first patient dosing in a Phase 1/2 study of AZD2936, a TIGIT/PD-1 bispecific antibody for lung cancer. This event marks the advancement of Compugen's COM902 program into clinical trials, contributing to its pipeline expansion. To date, Compugen has received a total of $12 million from AstraZeneca under their 2018 license agreement, which could potentially yield up to $200 million in milestone payments and royalties on sales.

On World Heart Day, the AstraZeneca HealthCare Foundation awarded $954,311 in grants to seven nonprofit organizations across the US to combat cardiovascular disease. This initiative is part of the Connections for Cardiovascular Health program aiming to enhance heart health among underserved communities. Since 2010, the Foundation has allocated over $25 million to various projects, impacting over 1.7 million individuals. The grant recipients include organizations addressing health screening, nutrition education, and access to healthcare services.

AstraZeneca will present data on its COVID-19 and RSV pipeline at the IDWeek 2021 conference, showcasing the long-acting antibody AZD7442 and its potential for COVID-19 prevention. Phase III PROVENT trial results indicate AZD7442 may reduce symptomatic COVID-19 risk significantly, particularly in vulnerable populations. The analysis will also cover the efficacy of AZD1222 in preventing asymptomatic infections and the recently developed nirsevimab for RSV protection in infants. Preliminary findings suggest that AZD7442 neutralizes emerging SARS-CoV-2 variants and regulatory submissions for emergency use authorization are forthcoming.

AstraZeneca and Merck have announced promising results from the PROpel Phase III trial of LYNPARZA® (olaparib) combined with abiraterone in treating men with metastatic castration-resistant prostate cancer (mCRPC). The trial demonstrated statistically significant improvement in radiographic progression-free survival (rPFS) compared to standard treatment. Although there was a trend towards better overall survival, further assessment is needed. The findings offer hope for new treatment options for patients with limited choices.

AstraZeneca's IMFINZI (durvalumab) has demonstrated significant progress in treating extensive-stage small cell lung cancer (ES-SCLC) according to updated results from the CASPIAN Phase III trial. The treatment, in combination with etoposide and either carboplatin or cisplatin, provides a 29% reduction in the risk of death compared to chemotherapy alone, with a median overall survival increased to 12.9 months. At three years, 17.6% of patients were alive on IMFINZI, compared to 5.8% with chemotherapy alone. The treatment remains well-tolerated with safety profiles consistent with established medications.

Results from the DESTINY-Breast03 Phase III trial indicate that ENHERTU significantly outperformed T-DM1 in treating previously treated HER2-positive breast cancer, offering a 72% reduction in progression risk (HR 0.28). With a median progression-free survival (PFS) not yet reached for ENHERTU versus 6.8 months for T-DM1 and a confirmed objective response rate (ORR) of 79.7%, the drug showcases promising efficacy. Safety data revealed manageable adverse events with no Grade 4 or 5 interstitial lung disease cases. These findings support ENHERTU's potential as a new standard of care.