AstraZeneca: FDA Priority Review for Enhertu could Boost Stock

AstraZeneca (AZN) and Daiichi Sankyo Company Limited (DSKYF) announced that the U.S. Food and Drug Administration (FDA) has granted priority review of the supplemental Biologics License Application (sBLA) for Enhertu (trastuzumab deruxtecan), jointly developed by Daiichi Sankyo and AstraZeneca.  

Enhertu is a HER2-directed antibody drug conjugate (ADC) designed to treat adult patients in the U.S. with unresectable or metastatic HER2-positive breast cancer. These patients include individuals who have received a prior anti-HER2-based regimen. 

Daiichi Sankyo is engaged in the research, development, manufacture, and sale of pharmaceuticals, while AstraZeneca is a British-Swedish multinational pharmaceutical and biotechnology company.   

The FDA grants Priority Review to medicines that potentially provide advanced treatments in the absence of alternatives. The Prescription Drug User Fee Act (PDUFA) target action date is during the second quarter of 2022. 

Supporting Data 

This application is based on data from the DESTINY-Breast03 trial that was presented during the European Society for Medical Oncology (ESMO) Congress 2021. The trial showed a 72% reduction in the risk of disease progression or death compared to trastuzumab emtansine (T-DM1). Additionally, the safety profile of Enhertu was consistent with prior clinical trials and no new safety concerns were identified. 

Globally, breast cancer is the most common cancer, with over two million cases being diagnosed in 2020, resulting in around 685,000 deaths. Around one in five cases of breast cancer are considered HER2-positive. 

Official Comments 

EVP of Oncology R&D at AstraZeneca, Susan Galbraith, said, “This review across geographies and the Priority Review in the US as part of Project Orbis is so important because it speaks to the transformative potential of Enhertu based on the unprecedented progression-free survival benefit in this setting. The news reinforces the importance of bringing this potential new option to patients as quickly as possible.” 

Prior Approvals 

In September 2021, Enhertu was granted the fourth Breakthrough Therapy Designation (BTD) in the U.S. to treat adult patients with unresectable or metastatic HER2-positive breast cancer. These included patients who received one or more prior anti-HER2-based regimens. 

Wall Street’s Take 

Recently, J.P. Morgan analyst James Gordon maintained a Buy rating and a price target of 10,000p (14.03% upside potential) on AZN stock. 

Consensus among analysts is a Strong Buy based on 10 Buys, 1 Hold, and 1 Sell. The average AstraZeneca stock forecast of 9,750p implies 11.17% upside potential from current levels. Shares have gained 16.7% over the past year. 

Smart Score 

AstraZeneca stock today scores a 9 of 10 from TipRanks’ Smart Score rating system, indicating that the stock has strong potential to outperform market expectations. With a balanced pipeline, AstraZeneca stock is expected to benefit from the positive news about the FDA action, boosting investors’ optimism on the stock. 

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