FDA grants priority review for AstraZeneca’s hypertension drug baxdrostat

WILMINGTON, Del. - The U.S. Food and Drug Administration has accepted AstraZeneca’s New Drug Application for baxdrostat with Priority Review status for the treatment of hard-to-control hypertension in adults, the company announced Tuesday. The pharmaceutical giant, with a market capitalization of $281.65 billion, has seen its shares rise 41.05% year-to-date as it continues to strengthen its product pipeline.

If approved, baxdrostat would become the first aldosterone synthase inhibitor to receive regulatory authorization. The FDA is expected to make a decision during the second quarter of 2026.

The application is based on results from the Phase III BaxHTN trial, which demonstrated statistically significant reductions in systolic blood pressure. At week 12, patients receiving 2mg of baxdrostat showed a placebo-adjusted reduction in systolic blood pressure of 9.8 mmHg, while those on the 1mg dose showed an 8.7 mmHg reduction.

"This Priority Review demonstrates our commitment to advancing baxdrostat as a potential first- and best-in-class aldosterone synthase inhibitor for the millions of people living with hard-to-control hypertension as quickly as possible," said Sharon Barr, Executive Vice President, BioPharmaceuticals R&D at AstraZeneca, in a press release statement.

Hypertension affects approximately 1.4 billion people worldwide. In the U.S., about 50% of patients on multiple treatments still do not have their blood pressure adequately controlled.

Baxdrostat works by selectively inhibiting aldosterone synthase, an enzyme responsible for producing aldosterone, a hormone that raises blood pressure and increases cardiovascular and renal risk.

The drug was generally well tolerated in clinical trials with most adverse events reported as mild, according to the company. AstraZeneca acquired baxdrostat through its purchase of CinCor Pharma in February 2023.

The company is currently investigating baxdrostat in clinical trials involving more than 20,000 patients globally for various conditions including hypertension, primary aldosteronism, chronic kidney disease, and heart failure prevention.

In other recent news, AstraZeneca has received FDA approval for its drug Imfinzi, in combination with FLOT chemotherapy, for treating early-stage gastric and gastroesophageal junction cancers. This approval follows a Priority Review and is based on results from the Phase III MATTERHORN trial, which demonstrated significant reductions in the risk of disease progression and death. Additionally, AstraZeneca is making a substantial investment of $2 billion to expand its manufacturing operations in Maryland. This expansion will nearly double the production capacity at its Frederick facility and establish a new clinical manufacturing site in Gaithersburg, creating 2,600 jobs. In terms of analyst activity, BofA Securities has raised its price target for AstraZeneca to $108.50, maintaining a Buy rating on the stock. The firm highlighted AstraZeneca’s valuation as attractive and included it in its list of top investment ideas. Furthermore, AstraZeneca has issued 67,907 shares under its employee share plans over a six-month period. These developments reflect AstraZeneca’s ongoing growth and strategic initiatives.

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