News | February 05, 2026
AstraZeneca & Daiichi Sankyo gain priority review for Datroway in hard-to-treat breast cancer
The FDA’s regulatory decision is expected in Q2 2026 under the Prescription Drug User Fee Act (PDUFA)
The FDA’s regulatory decision is expected in Q2 2026 under the Prescription Drug User Fee Act (PDUFA)
A final decision on the updated application is expected in the first half of 2026, while intravenous (IV) Saphnelo remains commercially available
Our portfolio transformation over the past few years positions us well to capitalize on improving end market conditions and deliver differentiated results in the years to come
Operating profit fell 1% in Danish kroner to DKK 127.7 billion but rose 6% at constant exchange rates
US revenue increased 43% to $12.9 billion, fueled by a 50% jump in volume, partially offset by a 7% decline in realized prices
The recommendation covers FYLREVY 14.2 mg and 18.9 mg for non-hysterectomised postmenopausal women experiencing oestrogen deficiency symptoms at least 12 months after their last menses
N17350 is the company’s first-in-class tumor-directed therapeutic, designed to harness the ELANE pathway
The approval follows the pivotal Phase III ARANOTE trial, which demonstrated that darolutamide plus ADT cut the risk of radiological progression or death by 46% compared to placebo plus ADT
The company maintained a competitive ARPOB while steadily improving occupancy, driven by higher patient volumes and efficient capacity utilization
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