AstraZeneca’s (AZN) New Drug Application, NDA, for baxdrostat has been accepted for Priority Review by the US Food and Drug Administration, FDA, in the US for the treatment of adult patients with hard-to-control hypertension as an add-on to other antihypertensive medicines when these do not provide adequate lowering of blood pressure. The Prescription Drug User Fee Act, PDUFA, date is anticipated during the second quarter of 2026 following use of a Priority Review voucher. The NDA is based on data from the BaxHTN Phase III trial which was presented during a Hot Line session at the European Society of Cardiology Congress 2025 and simultaneously published in the New England Journal of Medicine.
TipRanks Cyber Monday Sale
- Claim 60% off TipRanks Premium for data-backed insights and research tools you need to invest with confidence.
- Subscribe to TipRanks' Smart Investor Picks and see our data in action through our high-performing model portfolio - now also 60% off
Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>>
Read More on AZN:
- Vaccine committee considers changes to childhood schedule, NY Times reports
- Midday Fly By: Nvidia invests in Synopsys, U.S. strikes pharma deal with UK
- Trump Trade: U.S. confirms agreement with U.K. on pharmaceutical pricing
- Is AstraZeneca’s Stock (AZN) a Good Investment Right Now?
- US government confirms agreement in principle with UK on pharmaceutical pricing