AstraZeneca PLC - $AZN STOCK NEWS

AstraZeneca presents new data for TEZSPIRE and BREZTRI at ATS 2024 focusing on innovative treatments for COPD, severe asthma, and other respiratory diseases. Key highlights include the COURSE Phase IIa trial investigating tezepelumab in COPD patients and the potential of BREZTRI to reduce cardiopulmonary risk in COPD. The PR also covers advancements in asthma treatment, early pipeline science, and real-world evidence in COPD and asthma patients.

ENHERTU demonstrated a significant improvement in progression-free survival in HR-positive, HER2-low metastatic breast cancer patients in the DESTINY-Breast06 Phase III trial. The trial also showed a meaningful improvement in patients with HER2-ultralow expression. The results suggest that ENHERTU could become a new standard of care for this patient population, potentially redefining the treatment of metastatic breast cancer.

The safety profile of ENHERTU was consistent with previous breast cancer clinical trials, with no new safety signals identified. Overall survival data is still pending, but early trends show a potential improvement in patients with HER2-low metastatic breast cancer. The trial will continue to assess other secondary endpoints and further explore the potential of ENHERTU in the treatment landscape.

ENHERTU® Demonstrated Statistically Significant and Clinically Meaningful Improvement in Progression-Free Survival in HR Positive, HER2 Low Metastatic Breast Cancer Following One or More Lines of Endocrine Therapy in DESTINY-Breast06 Phase 3 Trial

ENHERTU (trastuzumab deruxtecan) has shown positive topline results in the DESTINY-Breast06 phase 3 trial, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to standard of care chemotherapy in patients with HR positive, HER2 low metastatic breast cancer following one or more lines of endocrine therapy. The trial also revealed a statistically significant and clinically meaningful improvement in PFS in the overall trial population, including patients with HER2 low and HER2 ultralow metastatic breast cancer. Additionally, ENHERTU is expected to become a new standard of care for patients with HER2 low and HER2 ultralow metastatic breast cancer following endocrine therapy, potentially challenging the current treatment paradigms for metastatic breast cancer treatment. The safety profile of ENHERTU remained consistent with previous breast cancer clinical trials.

ENHERTU, a specifically engineered HER2 directed DXd antibody drug conjugate, has displayed promising results in improving patient outcomes and presents a potential shift in the treatment landscape for HR positive, HER2 expressing metastatic breast cancer. The outcomes from DESTINY-Breast06 emphasize the potential for earlier use of ENHERTU in the treatment landscape and highlight the broad patient population that could benefit from this innovative treatment.

AbelZeta Pharma, Inc. announced the acceptance of an abstract related to the clinical study of C-CAR031, a CAR-T therapy for hepatocellular carcinoma, at the 2024 ASCO Annual Meeting. The therapy is developed in collaboration with AstraZeneca and will be presented in June 2024.

AstraZeneca reports very strong Q1 2024 financial results with a 19% increase in total revenue, driven by growth in product sales and alliance revenue. Core EPS grew by 13% to $2.06. The company reaffirmed its guidance for FY 2024, expecting double-digit growth in revenue and EPS. Key milestones include positive trial results for Imfinzi and Tagrisso in lung cancer.

Asher Biotherapeutics closes $55 million Series C financing led by RA Capital Management to advance lead program AB248 into Phase 1b Clinical Trials with support from AstraZeneca and Bristol Myers Squibb.

AstraZeneca's IMFINZI in combination with chemotherapy doubled the overall survival rate at three years for patients with advanced biliary tract cancer in the TOPAZ-1 Phase III trial. The results showed a 26% reduction in the risk of death compared to chemotherapy alone, with a median OS of 12.9 months for the combination therapy. The trial met the primary endpoint of OS in October 2021, showing a 20% reduction in the risk of death. IMFINZI plus chemotherapy continued to be well-tolerated with no new safety signals observed.

AstraZeneca's FASENRA (benralizumab) receives FDA approval for pediatric patients aged 6 to 11 with severe eosinophilic asthma, expanding treatment options. The approval is based on TATE trial data and prior trials, with a recommended dose of 30 mg for patients 6 years and older.

Daiichi Sankyo and AstraZeneca's ENHERTU receives U.S. FDA approval for the treatment of HER2 positive solid tumors after showing clinically meaningful responses. The drug is now approved for five indications, with the latest in metastatic cancers.