Recent Updates — AZN

AstraZeneca reported third-quarter total revenue of $16.2 billion, a 7% increase at constant exchange rates, driven by double-digit growth in Oncology, Respiratory & Immunology, and Rare Disease. Core earnings per share rose 17% to $2.79, while core operating profit increased 20%. The company reconfirmed its full-year guidance for mid-to-high single-digit total revenue growth and low double-digit core EPS growth at constant exchange rates. Additionally, AstraZeneca announced a $2 billion equity investment in Summit Therapeutics and initiated a restructuring program expected to cost up to $2 billion over three years while delivering $1.5 billion in annualized pre-tax benefits.

The European Commission has approved AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) as a monotherapy for the adjuvant treatment of adult patients with resected HER2-positive breast cancer who have residual invasive disease after neoadjuvant therapy. The approval is based on the DESTINY-Breast05 Phase III trial, which demonstrated that Enhertu reduced the risk of invasive disease recurrence or death by 53% compared to trastuzumab emtansine (T-DM1). As a result of this regulatory milestone, AstraZeneca is due to pay Daiichi Sankyo $75 million. This marks the first approval of Enhertu in the curative-intent early breast cancer setting in the EU.

The US Food and Drug Administration has granted accelerated approval to AstraZeneca’s Ultomiris (ravulizumab) as the first and only C5 complement inhibitor for reducing proteinuria in adults with primary immunoglobulin A nephropathy (IgAN). The decision follows a Priority Review based on prespecified interim results from the Phase III I CAN trial, which demonstrated a 43.4% reduction in proteinuria versus placebo at week 34. Continued approval is contingent upon verification of clinical benefit regarding kidney function decline in the ongoing trial. AstraZeneca PLC operates as a global biopharmaceutical company focused on oncology, rare disease, and biotherapeutics.

AstraZeneca has completed a $2 billion equity investment in Summit Therapeutics. The capital will accelerate the development of ivonescimab, a first-in-class bispecific antibody targeting PD-1 and VEGF, particularly in combination with antibody drug conjugates (ADCs). This follows previously announced clinical collaboration agreements to evaluate sonesitatug vedotin and Datroway alongside ivonescimab across multiple tumor types. AstraZeneca is a global biopharmaceutical company focused on the discovery, development, and commercialization of prescription medicines in oncology, rare disease, and biotherapeutics.

AstraZeneca and Daiichi Sankyo have entered into a clinical collaboration agreement with Summit Therapeutics to evaluate Datroway (datopotamab deruxtecan) in combination with ivonescimab across multiple tumor types, including lung and breast cancers. The partnership will initiate with a Phase III trial in first-line triple-negative breast cancer. Under the terms of the agreement, each company contributes its respective medicine and shares trial costs while retaining development and commercial rights to their own assets. This collaboration builds on AstraZeneca's recent equity investment in Summit Therapeutics, which supports clinical evaluations of ivonescimab combinations with various AstraZeneca oncology medicines. AstraZeneca PLC is a global biopharmaceutical company focused on the discovery, development, and commercialization of prescription medicines in Oncology, Rare Disease, and BioPharmaceuticals.