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AZN's Baxdrostat Gets FDA Priority Tag for Uncontrolled Hypertension
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Key Takeaways
AZN's NDA for baxdrostat targets adults with uncontrolled or treatment-resistant hypertension.
AZN's filing follows phase III data showing significant systolic blood pressure reductions with baxdrostat.
Baxdrostat was generally well tolerated with a safety profile aligned to its mechanism of action.
AstraZeneca (AZN - Free Report) announced that the FDA has accepted its new drug application (NDA) for baxdrostat for treating hard-to-control hypertension.
The NDA is seeking approval of baxdrostat for treating adult patients with hard-to-control (uncontrolled or treatment-resistant) hypertension as an add-on to other antihypertensive drugs when these do not offer adequate lowering of blood pressure.
With the FDA granting a priority review to the NDA, a decision from the regulatory body is expected in the second quarter of 2026.
If approved, baxdrostat could become the first aldosterone synthase inhibitor to gain regulatory approval in the United States.
AZN’s Price Performance
Year to date, shares of AstraZeneca have rallied 37.6% compared with the industry’s rise of 18.1%.
Image Source: Zacks Investment Research
The latest NDA for baxdrostat was based on data from the phase III BaxHTN study.
Data from the study showed that treatment with baxdrostat on top of standard of care led to statistically significant and clinically meaningful reduction in systolic blood pressure in patients with resistant or uncontrolled hypertension.
Treatment with baxdrostat was generally well tolerated and the safety profile was similar to its mechanism of action.
More on AZN’s 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.
The company recently announced positive top-line data from the Bax24 study, which showed that treatment with baxdrostat led to a statistically significant and highly clinically meaningful reduction in ambulatory 24-hour average systolic blood pressure versus placebo at 12 weeks.
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.
Baxdrostat is designed to lower blood pressure by selectively inhibiting aldosterone, a key hormone that elevates blood pressure and increases the risk of heart and kidney complications.
Besides hypertension, baxdrostat is also 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).
In the past 60 days, estimates for CorMedix’s 2025 earnings per share (EPS) have increased from $1.83 to $2.87. EPS estimates for 2026 have moved up from $2.48 to $2.88 during the same period. CRMD stock has surged 20.7% year to date.
CorMedix’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 27.04%.
In the past 60 days, estimates for Arcutis Biotherapeutics’ loss per share have narrowed from 44 cents to 24 cents for 2025. During the same time, EPS estimates for 2026 have increased from 9 cents to 41 cents. Year to date, shares of ARQT have rallied 111.3%.
Arcutis Biotherapeutics’ earnings beat estimates in each of the trailing four quarters, the average surprise being 64.80%.
In the past 60 days, estimates for ADMA Biologics’ EPS have increased from 57 cents to 58 cents for 2025. During the same time, EPS estimates for 2026 have improved from 88 cents to 90 cents. Year to date, shares of ADMA have gained 12.3%.
ADMA Biologics’ earnings beat estimates in one of the trailing four quarters, matched once and missed the same on the remaining two occasions, with the average negative surprise being 3.01%.
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AZN's Baxdrostat Gets FDA Priority Tag for Uncontrolled Hypertension
Key Takeaways
AstraZeneca (AZN - Free Report) announced that the FDA has accepted its new drug application (NDA) for baxdrostat for treating hard-to-control hypertension.
The NDA is seeking approval of baxdrostat for treating adult patients with hard-to-control (uncontrolled or treatment-resistant) hypertension as an add-on to other antihypertensive drugs when these do not offer adequate lowering of blood pressure.
With the FDA granting a priority review to the NDA, a decision from the regulatory body is expected in the second quarter of 2026.
If approved, baxdrostat could become the first aldosterone synthase inhibitor to gain regulatory approval in the United States.
AZN’s Price Performance
Year to date, shares of AstraZeneca have rallied 37.6% compared with the industry’s rise of 18.1%.
Image Source: Zacks Investment Research
The latest NDA for baxdrostat was based on data from the phase III BaxHTN study.
Data from the study showed that treatment with baxdrostat on top of standard of care led to statistically significant and clinically meaningful reduction in systolic blood pressure in patients with resistant or uncontrolled hypertension.
Treatment with baxdrostat was generally well tolerated and the safety profile was similar to its mechanism of action.
More on AZN’s 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.
The company recently announced positive top-line data from the Bax24 study, which showed that treatment with baxdrostat led to a statistically significant and highly clinically meaningful reduction in ambulatory 24-hour average systolic blood pressure versus placebo at 12 weeks.
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.
Baxdrostat is designed to lower blood pressure by selectively inhibiting aldosterone, a key hormone that elevates blood pressure and increases the risk of heart and kidney complications.
Besides hypertension, baxdrostat is also 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 CorMedix (CRMD - Free Report) , Arcutis Biotherapeutics (ARQT - Free Report) and ADMA Biologics (ADMA - Free Report) . While CRMD currently sports a Zacks Rank #1 (Strong Buy), ARQT and ADMA carry a Zacks Rank #2 (Buy) each, at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for CorMedix’s 2025 earnings per share (EPS) have increased from $1.83 to $2.87. EPS estimates for 2026 have moved up from $2.48 to $2.88 during the same period. CRMD stock has surged 20.7% year to date.
CorMedix’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 27.04%.
In the past 60 days, estimates for Arcutis Biotherapeutics’ loss per share have narrowed from 44 cents to 24 cents for 2025. During the same time, EPS estimates for 2026 have increased from 9 cents to 41 cents. Year to date, shares of ARQT have rallied 111.3%.
Arcutis Biotherapeutics’ earnings beat estimates in each of the trailing four quarters, the average surprise being 64.80%.
In the past 60 days, estimates for ADMA Biologics’ EPS have increased from 57 cents to 58 cents for 2025. During the same time, EPS estimates for 2026 have improved from 88 cents to 90 cents. Year to date, shares of ADMA have gained 12.3%.
ADMA Biologics’ earnings beat estimates in one of the trailing four quarters, matched once and missed the same on the remaining two occasions, with the average negative surprise being 3.01%.