AstraZeneca’s baxdrostat granted FDA priority review for hard-to-treat hypertension

AstraZeneca (LSE:AZN) has announced that the US Food and Drug Administration has accepted its new drug application for baxdrostat and granted it priority review. The therapy is intended for adults whose hypertension remains inadequately controlled despite existing treatment options.

The FDA has assigned a Prescription Drug User Fee Act (PDUFA) decision date in the second quarter of 2026.

AstraZeneca’s filing is supported by data from the Phase III BaxHTN study, which showed a statistically significant and clinically meaningful reduction in systolic blood pressure among participating patients. Baxdrostat is being developed to provide a new option for individuals whose high blood pressure remains difficult to manage using currently available medications.