WILMINGTON, Del.--(BUSINESS WIRE)--AstraZeneca and Daiichi Sankyo’s Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd) has been accepted in the US for the treatment of adult patients with locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) who have received prior systemic therapy. The Prescription Drug User Fee Act date, the Food and Drug Administration (FDA) action date for its regulatory decision, is during the fourth quarter of 2024. The BLA is based on r ...

WILMINGTON, Del.--(BUSINESS WIRE)--Positive high-level results from the LAURA Phase III trial showed AstraZeneca’s TAGRISSO® (osimertinib) demonstrated a statistically significant and highly clinically meaningful improvement in progression-free survival (PFS) for patients with unresectable, Stage III epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after chemoradiotherapy (CRT) compared to placebo after CRT. Overall survival (OS) data showed a favorable trend for TAGRISSO ...

AstraZeneca PLC (LSE:AZN) is set to see a sales boost from new lung cancer treatments, according to UBS analysts, after the pharmaceuticals firm updated on two treatments on Monday. UBS anticipated peak sales of US$2.5 billion for Dato-DXd, which saw its application accepted by the US Food and Drug Administration on Monday. Tagrisso, approved by the administration for use alongside chemotherapy in lung cancer patients, was forecast to bring incremental peak sales of US$500 million, meanwhile. AstraZeneca un ...

AstraZeneca PLC (LSE:AZN) shares swung 4% higher on Monday after it emerged that blockbuster drug Tagrisso (osimertinib), with the addition of chemotherapy, has been approved in the US for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC). The approval followed a priority review by the Food and Drug Administration (FDA) based on the results from the FLAURA2 Phase III trial published in The New England Journ ...

TOKYO & BASKING RIDGE, N.J.--(BUSINESS WIRE)--Daiichi Sankyo (TSE: 4568) and AstraZeneca’s (LSE/STO/Nasdaq: AZN) Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd) has been accepted in the U.S. for the treatment of adult patients with locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) who have received prior systemic therapy. Datopotamab deruxtecan is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) being jointly developed by Daiic ...

WILMINGTON, Del.--(BUSINESS WIRE)--AstraZeneca’s TAGRISSO® (osimertinib) with the addition of chemotherapy has been approved in the US for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC). The approval following a Priority Review by the Food and Drug Administration (FDA) was based on the results from the FLAURA2 Phase III trial published in The New England Journal of Medicine. TAGRISSO with the addition o ...

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AstraZeneca PLC (LSE:AZN) was among the FTSE 100’s big fallers on Monday as debate raged on around the company’s year-end earnings late last week. AstraZeneca found itself still reeling from what the market deemed disappointing earnings, with brokers having punished the pharmaceuticals giant over an unchanged dividend and lack of research and development newsflow. Indeed, shares slipped a further 1.9%, adding to losses last week, after Deutsche said it would “probably keep sitting on the fence were it not f ...

AstraZeneca PLC (LSE:AZN) faced a blow on Friday after Deutsche Bank analysts downgraded the pharmaceuticals giant on what they labelled a “thoroughly disappointing” end to 2023. Analysts wrote in a note that they saw shares in AstraZeneca falling over 300p on Thursday’s closing price to 9,500p, compared to previous guidance of a rise to 11,000p. This was coupled with a rating downgrade from ‘hold’ to ‘sell’ for AstraZeneca after the firm failed to impress with full-year results on Thursday. “Cash flow was ...

Astrazeneca (AZN) reported $12.02 billion in revenue for the quarter ended December 2023, representing a year-over-year increase of 7.3%. EPS of $0.73 for the same period compares to $0.69 a year ago.The reported revenue compares to the Zacks Consensus Estimate of $12.07 billion, representing a surprise of -0.42%. The company delivered an EPS surprise of -1.35%, with the consensus EPS estimate being $0.74.While investors closely watch year-over-year changes in headline numbers -- revenue and earnings -- and ...