AstraZeneca's Alexion Unit Gains FDA Nod for Ultomiris in IgAN,

AstraZeneca (AZN) announced FDA accelerated approval for Ultomiris to treat a rare kidney disease. The drug reduced proteinuria by 43.4% in a trial. The company aims for traditional approval after a 106-week trial. Over 200,000 U.S. patients have this condition, with half at high risk of kidney failure within a decade, according to AstraZeneca.

Amgen (AMGN) reported 10% revenue growth in Q2, with Tezspire sales up 42%. However, earnings per share rose just 4%, raising questions about earnings growth. The company's newer drugs, like Repatha and Imdelltra, drove growth, but older drugs face biosimilar competition. MariTide, an obesity drug, is a key focus for future earnings.

AstraZeneca's tozorakimab improved daily respiratory symptoms and reduced exacerbations in COPD patients in phase 3 OBERON and TITANIA trials. The drug showed significant improvements in breathlessness, cough, and chest symptoms. The FDA is reviewing tozorakimab for COPD under Priority Review, with a decision expected in Q1 2027.

Amgen and AstraZeneca reported positive Phase III trial results for Tezspire in treating eosinophilic oesophagitis (EoE). At week 52, 63.3–67.8% of patients achieved histologic remission, compared to 5.4% on placebo. The drug also reduced dysphagia symptoms and showed endoscopic remission in 29.5-34.4% of patients. Tezspire is already approved for severe asthma and chronic rhinosinusitis, and this new indication could expand its market potential.

AstraZeneca's Tezspire showed higher remission rates in eosinophilic esophagitis (EoE) patients than placebo in a phase 3 trial, with 67.8% and 63.3% remission for 210 mg and 420 mg doses, respectively, versus 5.4% for placebo. Both doses also improved swallowing scores. The trial enrolled 368 patients, and AstraZeneca plans to share findings with regulators.

Amgen and AstraZeneca reported positive Phase III trial results for Tezspire in treating eosinophilic oesophagitis, meeting primary endpoints. The study showed significant improvements in tissue remission and symptom reduction compared to placebo. Tezspire is already approved for severe asthma and chronic rhinosinusitis with nasal polyps in several regions. The companies plan to equally share costs and profits, with Amgen receiving a mid-single-digit royalty.