Astrazeneca Plc Stock Price, News & Analysis

Daiichi Sankyo and AstraZeneca announced the FDA's acceptance of the supplemental Biologics License Application (sBLA) for ENHERTU, designed for adult patients with unresectable or metastatic HER2 positive breast cancer. The application has received Priority Review and is part of the FDA's Real-Time Oncology Review and Project Orbis initiatives. ENHERTU showed a 72% reduction in disease progression or death versus T-DM1 in the DESTINY-Breast03 trial, with notable improvements in overall survival and objective response rates. The FDA action date is in Q2 2022.

AstraZeneca presented promising data on cancer treatments at the 2022 ASCO GI and GU Symposia, highlighting the efficacy of IMFINZI and LYNPARZA in liver, biliary tract, and prostate cancers. IMFINZI demonstrated a significant overall survival benefit in unresectable liver cancer with a novel dual immunotherapy regimen. In prostate cancer, LYNPARZA showcased its first clinical benefits combined with abiraterone. AstraZeneca aims to transform cancer care with innovative therapies and collaborations, emphasizing a commitment to improving patient outcomes.

AstraZeneca and Amgen announced the availability of TEZSPIRE™ (tezepelumab-ekko) for severe asthma patients in the US, following FDA approval on December 17, 2021. This biologic treatment uniquely targets thymic stromal lymphopoietin (TSLP) and has no phenotype or biomarker restrictions, addressing a wide range of severe asthma patients. Clinical trials demonstrated significant reductions in asthma exacerbations. Common side effects include pharyngitis and arthralgia. Both companies aim to ensure affordable access through their Tezspire Together Program and patient assistance initiatives.

Scorpion Therapeutics has partnered with AstraZeneca (AZN) to develop precision medicines targeting hard-to-reach cancer proteins known as transcription factors. This collaboration aims to enhance cancer treatment options by leveraging Scorpion's advanced drug discovery platform.

Scorpion will receive an upfront payment of $75 million, with potential overall earnings up to $1.5 billion from milestone payments. AstraZeneca will have exclusive rights to license up to three drug candidates, which could potentially revolutionize oncology treatment.

Fusion Pharmaceuticals (FUSN) announced the nomination of its first targeted alpha therapy (TAT) candidate in collaboration with AstraZeneca (AZN). This candidate utilizes Fusion's Fast-Clear™ linker technology and involves an actinium-225 radiolabeled bispecific antibody. The Phase 1 study is set to proceed following IND-enabling studies, with both companies sharing development costs. Fusion is also advancing its lead program, FPI-1434, targeting IGF-1R in Phase 1 trials, and has a pipeline that includes FPI-1966 and FPI-2059. The collaboration aims to explore up to three TATs and five combination therapies.

Daiichi Sankyo, in partnership with AstraZeneca, announced the validation of their Type II Variation application for trastuzumab deruxtecan by the EMA, aimed at treating unresectable or metastatic HER2 positive breast cancer. The application is based on the DESTINY-Breast03 trial, which demonstrated a 72% reduction in disease progression or death compared to T-DM1. The trial involved 524 patients globally, showing promising results with a median progression-free survival not reached for trastuzumab deruxtecan versus 6.8 months for T-DM1.

Daiichi Sankyo announces the initiation of the DESTINY-Lung04 phase 3 trial, dosing its first patient to evaluate ENHERTU® (trastuzumab deruxtecan) for treating HER2 mutant unresectable, locally advanced, or metastatic non-squamous non-small cell lung cancer (NSCLC).

This head-to-head trial compares ENHERTU to standard care (platinum-pemetrexed doublet chemotherapy with pembrolizumab), targeting a patient group with limited current treatment options. Lung cancer remains a top cancer mortality cause, with HER2 mutations observed in 2% to 4% of NSCLC cases.

AstraZeneca's EVUSHELD, a long-acting antibody therapy for COVID-19 prevention, shows retained neutralization efficacy against the Omicron variant, as reported by studies from University College Oxford and Washington University. With an IC50 of 273 ng/ml and 147 ng/ml, the data indicate promising neutralizing activity, ensuring its role in protecting vulnerable populations. EVUSHELD is the only antibody authorized in the US for pre-exposure prophylaxis against COVID-19, and its Emergency Use Authorization was granted in December 2021. Future publications will detail these findings further.

AstraZeneca's EVUSHELD, a long-acting antibody combination, has shown effectiveness against the Omicron variant of SARS-CoV-2 according to new preclinical data. The Inhibitory Concentration 50 (IC50) values were 171 ng/ml and 277 ng/ml, indicating significant neutralizing activity. EVUSHELD received Emergency Use Authorization (EUA) in December 2021 for pre-exposure prophylaxis in at-risk individuals. It demonstrated a 50% reduction in severe COVID-19 risk in non-hospitalized patients in the TACKLE Phase III trial. Further studies on its efficacy against Omicron are ongoing.