AstraZeneca PLC - AZN STOCK NEWS

Daiichi Sankyo and AstraZeneca have received EU approval for ENHERTU (trastuzumab deruxtecan) to treat adults with HER2 low (IHC 1+ or IHC 2+/ISH-) metastatic breast cancer. The therapy significantly reduced disease progression or death risk by 50% and increased median overall survival by over six months compared to chemotherapy. Approval is based on the pivotal DESTINY-Breast04 trial results, reinforcing ENHERTU as a potential new standard of care. Following this, AstraZeneca is due to pay $150 million to Daiichi Sankyo as a milestone payment.

AstraZeneca has initiated a tender offer to acquire all outstanding shares of CinCor Pharma for $26 per share in cash, plus a contingent value right of $10 per share linked to a regulatory submission for a baxdrostat product. Announced on 9 January 2023, the offer aims to close in Q1 2023, pending conditions including the tender of more than 50% of CinCor's shares. CinCor's board recommends stockholders accept the offer. The tender offer expires on 23 February 2023. The announcement highlights AstraZeneca's strategy in cardiovascular, renal, and metabolic diseases.

AIRSUPRA™ (albuterol/budesonide) has received FDA approval in the US for the as-needed treatment of asthma in adults, marking it as the first rescue medication addressing both bronchoconstriction and inflammation. The approval followed positive outcomes from the MANDALA and DENALI Phase III trials, with results showing a 27% reduction in severe exacerbation risk compared to standard albuterol. AIRSUPRA aims to tackle over 10 million annual asthma exacerbations in the US, potentially alleviating significant healthcare costs associated with uncontrolled asthma. The safety profile aligns with known component effects.

Tempus has announced a prospective study named Sculptor in collaboration with AstraZeneca (AZN) to identify biomarkers for small cell lung cancer (SCLC). The study, currently open for enrollment, aims to enhance therapeutic targeting for this aggressive cancer, which affects around 13% of lung cancer patients in the U.S. The initiative leverages Tempus' molecular profiling capabilities and aims to expand its dataset nationally through the TIME Trial Network, enhancing precision medicine approaches for SCLC treatment.

Genomic Vision has introduced its AI-powered software, FiberSmart^®, successfully tested by AstraZeneca (AZN) and the Fritz Lipmann Institute in Germany. This innovative software automates genomic analyses, focusing on the Replication Combing Assay (RCA), enhancing accuracy by threefold and speeding up processes by tenfold compared to prior solutions. The platform aims to provide a seamless user experience, optimizing the analysis of DNA replication kinetics. The launch is set for the coming weeks, promising significant advancements in genomic research.

Daiichi Sankyo and AstraZeneca announced that the European Medicines Agency (EMA) has validated the Type II Variation application for ENHERTU (trastuzumab deruxtecan) as a treatment for unresectable or metastatic non-small cell lung cancer (NSCLC) with HER2 mutations. The validation triggers the scientific review process based on results from the DESTINY-Lung01 and DESTINY-Lung02 trials, which showed significant tumor response. ENHERTU currently has multiple approvals in various countries, and this application aims to expand its use in Europe.

Daiichi Sankyo and AstraZeneca's ENHERTU has been recommended for EU approval as a monotherapy for patients with unresectable or metastatic HER2 low breast cancer. The CHMP’s positive opinion is based on the DESTINY-Breast04 phase 3 trial, where ENHERTU demonstrated a 50% reduction in disease progression or death risk compared to chemotherapy. It also showed a median overall survival of 23.4 months, outperforming chemotherapy's 16.8 months. This marks ENHERTU as the first HER2 directed therapy to show significant survival benefits in this patient population.

Daiichi Sankyo and AstraZeneca's ENHERTU has been approved in the EU for treating advanced HER2 positive gastric cancer, marking the first approval for such a treatment in over a decade. This decision is based on the positive results from the DESTINY-Gastric02 and DESTINY-Gastric01 trials, which showed significant efficacy with an overall response rate of 41.8% and a median duration of response of 8.1 months in one trial. A milestone payment of $35 million is due from AstraZeneca to Daiichi Sankyo following this approval, reinforcing the financial implications for both companies.

AstraZeneca announced a total of $4 million in financial contributions to 52 nonprofit organizations through its second annual Accelerate Change Together (ACT) on Health Equity. The funds aim to enhance health equity and promote STEM among underrepresented communities in the US. Out of over 1,000 applications, 38 community-based nonprofits will receive $25,000 each. Additionally, 14 national nonprofits will share $3 million for health equity programs.