AstraZeneca is set to release its third-quarter 2024 earnings on Tuesday, with investors eager to see continued growth in its oncology and cardiovascular divisions. The company’s strong second-quarter performance, driven by key drugs like Tagrisso, Imfinzi, Calquence, and Farxiga, has fueled optimism for the upcoming report.
AstraZeneca, through its exclusive licensing agreement with Eccogene, is advancing the development of ECC5004, a potential oral once-daily glucagon-like peptide 1 receptor agonist (GLP-1RA) for obesity treatment. Early data from clinical trials presented at ObesityWeek 2024 suggests ECC5004 exhibits a favorable safety profile, has the potential for once-daily dosing, and may be administered with or without food. This promising early data positions AstraZeneca to be a potential contender in the competitive weight loss market.
The FDA has granted Priority Review to AstraZeneca’s Calquence (acalabrutinib) for the treatment of previously untreated mantle cell lymphoma (MCL). This decision follows promising results from the ECHO Phase III trial, which demonstrated that Calquence, in combination with bendamustine and rituximab, significantly reduced the risk of disease progression or death compared to standard-of-care chemotherapy.
The FDA has approved AstraZeneca’s Tagrisso for treating adult patients with unresectable, Stage III epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) whose disease has not progressed after radiation therapy. The drug, which generated $1.6 billion in sales in the second quarter of 2024, showed a significant reduction in disease progression or death compared to placebo in a Phase 3 trial.
AstraZeneca’s datopotamab deruxtecan (Dato-DXd) failed to meet its primary endpoint of overall survival in a Phase 3 breast cancer trial, but the drug continues to show potential in treating lung cancer. The drug did achieve its primary endpoint in the breast cancer trial for progression-free survival and also demonstrated improvement in patient-reported outcomes.
The FDA has approved AstraZeneca’s Fasenra (benralizumab) for the treatment of eosinophilic granulomatosis with polyangiitis (EGPA), a rare and serious inflammatory condition. The approval is based on positive results from a Phase 3 trial showing comparable efficacy and safety to the current standard treatment. Fasenra is now the second biologic approved for EGPA, providing a new option for patients battling this debilitating disease.
AstraZeneca is facing an investigation in China concerning alleged illegal activities, including potential breaches of data privacy laws and importing unlicensed cancer medications. The probe involves several current and former employees, with the company emphasizing its compliance with Chinese policies.
Five current and former AstraZeneca employees have been detained in China as part of an investigation into alleged illegal activities in the pharmaceutical sector. The investigation focuses on potential breaches of data privacy laws and the importation of unlicensed cancer medications, highlighting China’s crackdown on unethical practices within the healthcare industry.
The FDA has approved AstraZeneca’s Imfinzi (durvalumab) in combination with chemotherapy for adult patients with resectable early-stage non-small cell lung cancer (NSCLC) who do not have certain genetic mutations. This approval is based on positive results from the AEGEAN trial, demonstrating a significant reduction in the risk of recurrence and improved pathological complete response rates. Imfinzi is also being evaluated for use in limited-stage small cell lung cancer.
AstraZeneca has received EU approval for its combination therapy of Imfinzi (durvalumab) and Lynparza (olaparib) to treat specific patients with advanced or recurrent endometrial cancer. The approval is based on data from the DUO-E study showing significant reductions in disease progression or death for both mismatch repair proficient and deficient patients.
