AZN's key medicines, mainly cancer drugs, Lynparza, Tagrisso and Imfinzi, and diabetes medicine Farxiga are expected to have driven the company's top line.
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The FDA approves AstraZeneca's sBLA for Enhertu to treat HER2-low or HER2-ultralow metastatic breast cancer in the United States.
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AstraZeneca is one of the fastest-growing players among Big Pharma. The company's significant balance sheet strengthening in recent years has been driven by the rapid expansion of its portfolio of FDA-approved drugs, particularly those targeting cancer. So, one of AstraZeneca's latest achievements was the FDA's approval of Datroway on January 17, 2025, for the treatment of certain adults with breast cancer.
On Friday, the U.S. Food and Drug Administration (FDA) approved AstraZeneca Plc's AZN Datroway (datopotamab deruxtecan or Dato-DXd) for adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease.
The FDA's nod is based on late-stage data, which show AZN's Datroway cuts the risk of disease progression/death by 37% vs chemotherapy in certain breast cancer patients.
My thesis initiates coverage of big pharma stock AstraZeneca, with an initial buy rating, agreeing with today's bullish consensus. Positive upside is driven by the diverse portfolio of solutions to meet the clinical demand, and a pipeline of new projects awaiting drug approval. Although the profit margin is weaker than peers, the company is cashflow positive and has positive/stable credit ratings.
The U.S. Food and Drug Administration has approved AstraZeneca and partner Daiichi Sankyo's precision drug to treat a type of breast cancer, the health regulator said on Friday.
AstraZeneca has overhauled its local management in China, replacing Michael Lai with Alex Lin as the country's general manager, the Financial Times reported on Friday, citing two people with direct knowledge of the matter.
The US Food and Drug Administration (FDA) has approved AstraZeneca PLC's (LSE:AZN) Calquence (acalabrutinib), in combination with bendamustine and rituximab, as a first-line treatment for adults with previously untreated mantle cell lymphoma (MCL) who cannot undergo stem cell transplantation. This approval marks the first time a Bruton's tyrosine kinase (BTK) inhibitor has been authorised in the US for newly diagnosed MCL patients.
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