AstraZeneca Gets Accelerated FDA Nod for Ultomiris in IgA Nephropathy

AstraZeneca will start selling sunvozertinib, a lung cancer drug developed by China's Dizal Pharmaceutical, in the US after delays. The FDA approved the drug in July 2025, but it was unavailable in the US for over a year, prompting some Americans to travel to China for treatment.

The NCCN upgraded durvalumab (Imfinzi; AstraZeneca) recommendations in its Esophageal and Esophagogastric Junction Cancers guidelines, moving certain subgroups from category 2B to 2A. The MATTERHORN trial showed improved survival rates with durvalumab plus FLOT. Zanidatamab-hrii combinations were added for HER2-positive adenocarcinoma. Durvalumab plus FLOT was FDA-approved in 2025.

AstraZeneca PLC (AZN) rose 3.04% on Oct 22, outperforming its sector. The FDA granted accelerated approval for Ultomiris to treat a rare kidney disease, expanding its portfolio. The company also reported positive trial results for Tezspire and Zegfrovy. Analysts have an average price target of $210.32. Risks include clinical trial setbacks and patent expirations.

The FDA granted accelerated approval to AstraZeneca's ravulizumab (Ultomiris) to reduce proteinuria in adults with primary IgA nephropathy (IgAN). The approval is based on proteinuria reduction, with continued approval contingent on confirming clinical benefit in the ongoing I CAN trial. Ravulizumab is the first C5 inhibitor approved for this use, and IgAN is its fifth approved indication. The drug reduced 24-hour UPCR by 46.6% in a trial, compared to 5.6% for placebo.

AstraZeneca and Amgen's tezepelumab showed significant improvement in histologic remission and dysphagia symptoms for eosinophilic esophagitis patients at 24 and 52 weeks, outperforming placebo. The phase 3 study enrolled 365 participants, with both 210 mg and 420 mg doses showing sustained benefits. Tezepelumab was well tolerated, with similar adverse event rates to placebo.

AstraZeneca and Amgen's TEZSPIRE showed significant improvements in histologic remission and dysphagia symptoms in eosinophilic esophagitis patients at week 24, with sustained results through week 52. The trial, presented at UEGW 2026, reported 64.8% and 68.9% remission rates for 210mg and 420mg doses, respectively, vs. 3.5% for placebo. TEZSPIRE also reduced dysphagia symptoms and improved endoscopic features. The drug is approved for severe asthma and CRSwNP.