AstraZeneca AZN announced that the FDA has approved baxdrostat for treating adult patients with uncontrolled or treatment-resistant hypertension as an add-on to other antihypertensive drugs.
Baxdrostat, a first-in-class aldosterone synthase inhibitor (ASI), will be marketed as Baxfendy. Following the nod, Baxfendy became the first and only ASI to be approved for treating adults with hypertension in the United States.
Baxfendy works by specifically blocking the production of aldosterone, a key hormone that can raise blood pressure and increase the risk of heart and kidney diseases.
AZN’s Price Performance
Year to date, shares of AstraZeneca have lost 1.3% compared with the industry’s decline of 1.6%.
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The approval for Baxfendy was based on positive data from the phase III BaxHTN study.
Data from the study showed that treatment with Baxfendy (both 2mg and 1mg doses) led to statistically significant and clinically meaningful reduction in systolic blood pressure in patients with resistant or uncontrolled hypertension.
At week 12, patients receiving the 2 mg dose of Baxfendy achieved a placebo-adjusted reduction of 9.8 mmHg in systolic blood pressure, while those who received the 1 mg dose achieved an 8.7 mmHg reduction. The drug was generally well-tolerated, with no unexpected safety concerns reported in the study.
Per AZN, hypertension affects 1.4 billion people globally. In the United States, about half of patients on multiple therapies still have uncontrolled blood pressure, with growing evidence linking this to aldosterone dysregulation.
Per management, the latest approval of Baxfendy represents the first major therapeutic innovation for hypertension in nearly two decades and could address a significant unmet need among patients. The drug could strengthen the company’s cardiovascular portfolio.
AZN’s Other Development Activities With Baxdrostat
Besides hard-to-control hypertension, AstraZeneca is also evaluating baxdrostat in the phase III Bax24 study in patients with resistant hypertension.
Baxdrostat is being investigated as a monotherapy for hypertension and primary aldosteronism. Baxdrostat, in combination with dapagliflozin, is also being evaluated for treating chronic kidney disease and the prevention of heart failure in patients with hypertension.
AZN’s Zacks Rank & Stocks to Consider
AstraZeneca currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Amarin AMRN, Immunocore IMCR and Liquidia Corporation LQDA, each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, 2026 loss per share estimates for Amarin have narrowed from $7.01 to $6.36, while the same for 2027 have narrowed from $5.50 to $4.64 during the same time. AMRN stock has risen 4.4% year to date.
Amarin's earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 50.02%.
Over the past 60 days, 2026 loss per share estimates for Immunocore have narrowed from 97 cents to 16 cents, while estimates for 2027 have moved from a loss of 39 cents per share to earnings of 11 cents during the same time. IMCR stock has lost 19.2% year to date.
Immunocore’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 46.66%.
Over the past 60 days, estimates for Liquidia’s 2026 earnings per share have risen from $1.50 to $2.97, while estimates for 2027 have increased from $2.91 to $4.81 during the same time. LQDA shares have surged 65.1% year to date.
Liquidia’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 54.40%.
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AstraZeneca PLC (AZN): Free Stock Analysis Report
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This article originally published on Zacks Investment Research (zacks.com).