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Source document· December 2, 2025

Baxdrostat New Drug Application accepted under FDA Priority Review in the US for patients with hard-to-control hypertension

View original at finance.yahoo.com
Baxdrostat New Drug Application accepted under FDA Priority Review in the US for patients with hard-to-control hypertension Submission based on positive BaxHTN Phase III trial results which demonstrated statistically significant and clinically meaningful reduction in systolic blood pressure in patients with resistant o…
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  • Baxdrostat was generally well tolerated with a safety profile consistent with its mechanism of action. There were no unanticipated safety findings, and most adverse events were mild

    80% confidence
  • 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

    80% confidence
  • The substantial reduction in systolic blood pressure seen in the BaxHTN trial underscores baxdrostat's novel mechanism of action and its potential to bring innovation to a disease area that has seen limited progress in over two decades

    80% confidence
  • If approved, baxdrostat could be the first aldosterone synthase inhibitor to receive regulatory authorization

    80% confidence

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AstraZeneca AB · global market presence125 countries
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Baxdrostat New Drug Application accepted under FDA Priority Review in the US for patients with hard-to-control hypertension — Source | Via News | Via News