AstraZeneca reported positive Phase 3 results for its Claudin 18.2-targeting antibody-drug conjugate (ADC) sonesitatug vedotin (AZD0901/CMG901) in patients with Claudin 18.2-positive gastric, gastroesophageal junction, and esophageal adenocarcinoma cancers, reinforcing expectations of blockbuster sales for this first‑in‑class CLDN18.2 ADC.
The company projected that sonesitatug vedotin could become a key growth driver in its oncology portfolio, with external analyses estimating its US peak annual sales in the low hundreds of millions by 2039, while the broader Claudin 18.2‑targeted therapy market is projected to reach roughly $1.26 billion in the United States by 2036.
Simultaneously, AstraZeneca’s rare disease drug Ultomiris (ravulizumab) failed to meet the primary endpoint of event‑free survival at 26 weeks in a late‑stage trial in hematopoietic stem cell transplant‑associated thrombotic microangiopathy (HSCT‑TMA), marking another setback for the complement inhibitor in rare disease indications.
Ultomiris has previously flopped in ALS and faced regulatory setbacks in neuromyelitis optica spectrum disorder (NMOSD) in the U.S., even as its existing indications continue to drive strong sales, with the drug contributing over $1 billion in a recent quarter despite these pipeline disappointments.
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