AstraZeneca (AstraZeneca (AZN)) had a busy Friday with the FDA. The agency approved a new use for its cancer drug Truqap and gave a Priority Review to its kidney disease treatment Ultomiris. That's two pieces of good news in one day, which is a pretty solid way to end the week.

Truqap: A First for a Tough Prostate Cancer

The FDA approved Truqap (capivasertib) in combination with abiraterone and prednisone for adults with PTEN-deficient metastatic prostate cancer. This is a specific type of prostate cancer that has been hard to treat because there haven't been targeted options. Now there is one.

The approval is for patients with what's now called "metastatic androgen pathway modulation-naïve or sensitive" disease—basically, men whose cancer has spread but hasn't yet been treated with hormone therapy. The regimen is the first and only targeted treatment for this group, and it requires an FDA-authorized test to identify PTEN deficiency.

The decision was backed by the Phase III CAPItello-281 trial, which showed that the Truqap combo reduced the risk of disease progression or death by 19% compared to abiraterone alone. Patients on the Truqap regimen had a median progression-free survival of 33.2 months, versus 25.7 months in the control group. That's an extra 7.5 months without the cancer getting worse—a meaningful improvement for these patients.

The FDA also approved a companion diagnostic test to identify PTEN deficiency in prostate tumors, so doctors can figure out who might benefit.

Ultomiris Gets a Fast Track for Kidney Disease

Separately, the FDA accepted and granted Priority Review to AstraZeneca's application for Ultomiris (ravulizumab) to treat IgA nephropathy (IgAN), a rare kidney disease. Priority Review means the FDA thinks this drug could be a meaningful improvement over existing treatments, and they'll make a decision within six months—so by the fourth quarter of 2026.

The application is based on interim data from the Phase 3 I CAN trial, presented at the 2026 European Renal Association Congress. The results were striking: Ultomiris reduced the 24-hour urine protein creatinine ratio by 46.6% from baseline at week 34, compared to just 5.6% for placebo. That's a placebo-adjusted treatment effect of 43.4%. The reduction appeared as early as week 10 and held through week 34.

The drug was generally well tolerated, with no new safety concerns. That's always good to hear.

As of Monday, AstraZeneca shares were down 0.77% at $177.37. But with two regulatory wins in hand, the long-term outlook looks a bit brighter.