FORM 6-K
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
Report
of Foreign Issuer
Pursuant
to Rule 13a-16 or 15d-16 of
the
Securities Exchange Act of 1934
For the
month of May 2026
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
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AstraZeneca PLC
INDEX
TO EXHIBITS
1. Baxfendy
approved in the US for hypertension
18 May 2026
Baxfendy approved
in the US as the first and only aldosterone synthase
inhibitor treatment for adults with
hypertension
Approval based on BaxHTN Phase III results showing
statistically significant and clinically meaningful reduction
in systolic blood pressure in patients with uncontrolled or
resistant hypertension
Baxfendy 2mg lowered systolic blood pressure by 15.7 mmHg (9.8 mmHg
placebo-adjusted) from baseline in BaxHTN trial
AstraZeneca's Baxfendy (baxdrostat) has been approved in the US as
a first-in-class aldosterone synthase inhibitor (ASI) for the
treatment of hypertension in combination with other
antihypertensive medications, to lower blood pressure in adults who
are not adequately controlled.
There are 1.4 billion people worldwide living with
hypertension.1 In
the US, approximately 50% of patients living with hypertension who
are already taking multiple antihypertensive medications still
struggle with persistently elevated blood
pressure,2 which
is a leading risk factor for cardiovascular disease and premature
death.3,4 Hypertension is
the most prevalent and significant modifiable cardiovascular risk
factor worldwide, accounting for more deaths and disability than
any other modifiable risk.5-7
Baxfendy is a
first-in-class, highly selective and potent ASI designed to lower
blood pressure in a new way by specifically inhibiting the
production of aldosterone,8 a
hormone that raises blood pressure to unhealthy levels and
increases the risk of heart and kidney problems.9-11
The approval by the US Food and Drug Administration (FDA) was based
on positive results from the BaxHTN Phase III
trial,12 with Baxfendy demonstrating
statistically significant and clinically meaningful seated systolic
blood pressure reduction at both 2mg and 1mg doses in patients with
uncontrolled and resistant hypertension on two or more
medications. Baxfendy was generally well-tolerated with no
unanticipated safety findings.
Dr. Bryan Williams, Chair of Medicine at University College London,
and BaxHTN primary investigator, said: "We have been waiting for an
innovative medication like Baxfendy for hypertension for many years. Its novel
way of lowering blood pressure has the potential to transform
clinical practice by targeting a root cause of persistently
uncontrolled hypertension. In addition, the nearly double-digit
placebo-adjusted systolic blood pressure reduction achieved
with Baxfendy is exciting and clinically meaningful for
clinicians and patients. Epidemiological data indicate that a 10
mmHg decrease in systolic blood pressure is associated with a
roughly 20% lower risk of serious cardiovascular
events."
John M. Clymer, Executive Director, National Forum for Heart
Disease & Stroke Prevention, said: "Hypertension remains a
staggeringly widespread silent killer and a leading risk factor for
stroke, heart attack, kidney damage and dementia. Tens of millions
of people struggle to control their blood pressure despite
lifestyle changes and currently available treatments. Innovative,
new treatments could help millions protect their heart, kidney and
brain health."
Ruud Dobber, Executive Vice President, BioPharmaceuticals Business
Unit, AstraZeneca, said: "The approval of Baxfendy offers a much-needed, first-in-class innovation for people
living with persistently uncontrolled hypertension who have not
responded to or tolerated existing medicines. In the US, about 23
million patients are uncontrolled despite being on two or more
medicines for hypertension, which is a disease that has seen little
therapeutic progress for the past two decades."
In the BaxHTN Phase III trial,13 published
in the New
England Journal of Medicine,12 Baxfendy (baxdrostat)
demonstrated statistically significant and clinically meaningful
efficacy for the treatment of patients with hypertension on top of
standard of care. At week 12, the absolute reduction from baseline
in mean seated SBP was 15.7 mmHg (95% confidence interval [CI],
-17.6 to -13.7) and placebo-adjusted reduction was 9.8 mmHg (95%
CI, -12.6 to -7.0; p<0.001) for the 2mg dose. For the 1mg dose,
the absolute reduction from baseline was 14.5 mmHg (95% CI, -16.5
to -12.5) and placebo-adjusted reduction was 8.7 mmHg (95% CI,
-11.5 to -5.8; p<0.001). The reduction in mean seated SBP with
placebo was 5.8 mmHg (95% CI, -7.9 to -3.8). Results were
consistent across both uncontrolled and treatment-resistant
subgroups.
Notes
Uncontrolled hypertension
Hypertension is a medical condition characterised by consistently
high blood pressure levels, affecting an estimated 1.4 billion
people worldwide.1,14,15 Over
time, this can damage blood vessels and vital organs, increasing
the risk of serious health problems such as heart attack, stroke,
heart failure and kidney disease.14,15
Treated but uncontrolled patients with hypertension are at a
significantly greater risk of all-cause mortality, heart-disease
specific mortality, stroke-related mortality, CVD-specific
mortality and dementia than patients whose hypertension is
controlled. A large meta-analysis found that lowering systolic
blood pressure by 10 mmHg can reduce the risk of major adverse
cardiovascular events by around 20%,16 underscoring
the urgent need for new treatments that target a key hypertension
pathway at its source.
An observational study of nearly 60,000 patients studied over a
median of 9.7 years showed that a 9.5 mmHg increase in SBP was
associated with a 30% increase in risk of all-cause mortality and
41% increase in risk of cardiovascular death.17 Studies
have shown that increased night-time blood pressure is associated
with higher cardiovascular risk,18,19 and
patients with hypertension have a higher risk of cardiovascular
events like heart attack, stroke and death around the time of their
morning blood pressure surge.20,21
Aldosterone, a hormone that raises blood pressure to unhealthy
levels by promoting sodium and water retention9,10 is
a key contributor to persistently uncontrolled hypertension.
Elevated aldosterone levels, along with factors such as obesity,
high salt intake and various genetic or secondary
conditions,22 are
strongly associated with poor blood pressure control and the
progression of heart failure and kidney disease. When left
untreated, hypertension significantly increases the risk of
cardiovascular and kidney-related complications.5,14,23
BaxHTN trial
The BaxHTN Phase III trial13 had
three components to it that supported the following endpoints. The
primary endpoint was assessed during a 12-week double-blind,
placebo-controlled period. A total of 796 patients were
characterised in a 1:1:1 ratio to receive Baxfendy 2mg, 1mg or placebo once daily on top of
standard of care [2 antihypertensive agents at baseline, one of
which is a diuretic for uncontrolled hypertension and ≥ 3
antihypertensive agents at baseline, one of which is a diuretic for
resistant hypertension].The primary efficacy endpoint was the
difference in mean change from baseline in seated SBP at week 12
between participants treated with baxdrostat (2mg or 1mg
separately) and participants treated with placebo. Persistence of
efficacy was assessed during a randomised withdrawal period from
week 24 to week 32. Approximately 300 patients treated
with Baxfendy 2mg were re-randomised in a 2:1 ratio to
either continue receiving baxdrostat 2mg or placebo for the 8
weeks. SBP at the end of the 8 weeks was compared with placebo and
the Baxfendy 2mg dose. Long-term safety was assessed at
the end of the 52 weeks compared to a standard of care
arm.
Additional confirmatory secondary endpoints include the effect
of Baxfendy versus placebo on seated SBP at week 12 in
the resistant hypertension subpopulation, the effect
of Baxfendy versus placebo on seated diastolic blood
pressure at week 12, and proportion of participants achieving
seated SBP less than 130 mmHg at week 12.
Baxfendy and the clinical development
programme
Baxfendy is a
first-in-class, highly selective and potent, oral, small molecule
that inhibits aldosterone synthase,8 an
enzyme encoded by the CYP11B2 gene, which is responsible for the
synthesis of aldosterone in the adrenal gland.10 In
clinical trials, Baxfendy was observed to significantly lower
aldosterone levels without affecting cortisol levels across a wide
range of doses.24,25
As part of a broad development programme, Baxfendy is currently being investigated in clinical
trials in other conditions where high aldosterone plays a role in
elevating cardiorenal risk, including as a monotherapy for primary
aldosteronism,26 and
in combination with dapagliflozin for chronic kidney disease and
hypertension,27,28 and
the prevention of heart failure in patients with
hypertension.29 Additional
clinical data for Baxfendy in hypertension includes positive data from
the Bax24 Phase III trial,30 which
showed a statistically significant and highly clinically meaningful
placebo-adjusted reduction of 24-hour ambulatory systolic blood
pressure in patients with resistant hypertension, with full results
published in The
Lancet.31
AstraZeneca acquired Baxfendy through its purchase of CinCor Pharma, Inc.
in February 2023.32
AstraZeneca in CVRM
Cardiovascular, Renal and Metabolism (CVRM), part of
BioPharmaceuticals, forms one of AstraZeneca's main disease areas
and is a key growth driver for the Company. By following the
science to understand more clearly the underlying links between the
heart, kidneys, liver and pancreas, AstraZeneca is investing in a
portfolio of medicines for organ protection by slowing or stopping
disease progression, and ultimately paving the way towards
regenerative therapies. The Company's ambition is to improve and
save the lives of millions of people, by better understanding the
interconnections between CVRM diseases and targeting the mechanisms
that drive them, so we can detect, diagnose and treat people
earlier and more effectively.
AstraZeneca
AstraZeneca (LSE/STO/NYSE: AZN) is a global, science-led
biopharmaceutical company that focuses on the discovery,
development, and commercialisation of prescription medicines in
Oncology, Rare Disease, and BioPharmaceuticals, including
Cardiovascular, Renal & Metabolism, and Respiratory &
Immunology. Based in Cambridge, UK, AstraZeneca's innovative
medicines are sold in more than 125 countries and used by millions
of patients worldwide. Please visit astrazeneca.com and follow the
Company on Social Media @AstraZeneca.
Contacts
For details on how to contact the Investor Relations Team, please
click here.
For Media contacts, click here.
References
1.
World Health Organization. Global report on hypertension 2025: high
stakes: turning evidence into action. 2025.
https://iris.who.int/handle/10665/382841. Accessed September
2025.
2. Carey RM, et al. Prevalence of
Apparent Treatment-Resistant Hypertension in the United
States. Hypertension.2019;73(2):424-431.
3. Rapsomaniki E, et al. Blood
pressure and incidence of twelve cardiovascular diseases: lifetime
risks, healthy life-years lost, and age-specific associations in
1·25 million people. Lancet. 2014 May
31;383(9932):1899-911.
4. GBD 2019 Risk Factors
Collaborators. Lancet. 2020;396:1223-1249.
5. Zhou D, et al. Uncontrolled
hypertension increases risk of all-cause and cardiovascular disease
mortality in US adults: the NHANES III Linked Mortality
Study. Sci Rep. 2018: 20;8(1):9418.
6.
Hall ME et al. Weight-loss strategies for prevention and treatment
of hypertension: a scientific statement from the American Heart
Association. Hypertension. 2021;78:e38-e50.
7.
GBD 2023 Disease and Injury and Risk Factor Collaborators. Burden
of 375 diseases and injuries, risk-attributable burden of 88 risk
factors, and healthy life expectancy in 204 countries and
territories, including 660 subnational locations, 1990-2023: a
systematic analysis for the Global Burden of Disease Study 2023.
Lancet. 2025;406:1873-1922.
8. Bogman K, et al. Preclinical and
early clinical profile of a highly selective and potent oral
inhibitor of aldosterone synthase
(CYP11B2). Hypertension.
2017;69:189-96.
9. Inoue K, et al. Serum aldosterone
concentration, blood pressure, and coronary artery calcium: the
Multi-Ethnic Study of Atherosclerosis [including online
supplement]. Hypertension.
2020;76(1):113-120.
10. Cannavo A, et al. Aldosterone and
mineralocorticoid receptor system in cardiovascular physiology and
pathophysiology. Oxid Med Cell
Longev.
2018;2018:1204598.
11.
Xanthakis V, Vasan RS. Aldosterone and the risk of hypertension.
Curr Hypertens Rep. 2013;15(2):102-107.
12. Flack JM, et al. Efficacy and Safety of
Baxdrostat in Uncontrolled and Resistant
Hypertension. N Engl J
Med. 2025. Aug
30:10.1056/NEJMoa2507109. doi:
10.1056/NEJMoa2507109.
13. ClinicalTrials.gov. A Study to
Investigate the Efficacy and Safety of Baxdrostat in Participants
With Uncontrolled Hypertension on Two or More Medications Including
Participants With Resistant Hypertension (BaxHTN). Available
at: https://clinicaltrials.gov/study/NCT06034743.
Accessed April 2026.
14. McEvoy JW, et al. 2024 ESC Guidelines
for the management of elevated blood pressure and
hypertension. EurHeart J. 2024;45(38):3912-4018.
15. Whelton PK, et al. 2017
ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the
Prevention, Detection, Evaluation, and Management of High Blood
Pressure in Adults: Executive Summary: A Report of the American
College of Cardiology/American Heart Association Task Force on
Clinical Practice Guidelines. Hypertension.
2018;71(6):1269-1324.
16. Ettehad, D. et al. Blood pressure
lowering for prevention of cardiovascular disease and death: a
systematic review and meta-analysis; Lancet 2016;387:957-67.
17.
Staplin N, et al. Relationship between clinic and ambulatory blood
pressure and mortality: an observational cohort study in
59 124 patients. Lancet.
2023;401(10393):2041-2050.
18. Narita K, et al. Nighttime Home Blood
Pressure Is Associated With the Cardiovascular Disease Events Risk
in Treatment-Resistant Hypertension. Hypertension.
2022;79(2):e18-e20
19.
Niiranen TJ, Mäki J, Puukka P, Karanko H, Jula AM. Office,
home, and ambulatory blood pressures as predictors of
cardiovascular risk. Hypertension. 2014
Aug;64(2):281-6.
20. Renna NF, et al. Morning blood pressure
surge as a predictor of cardiovascular events in patients with
hypertension. Blood Press
Monit. 2023;28(3):149-157
21. Kario K et al. Morning hypertension: the
strongest independent risk factor for stroke in elderly
hypertensive patients. Hypertens
Res. 2006;29(8):581-7.
22. van Oort S, et al. Association of
cardiovascular risk factors and lifestyle behaviors with
hypertension: a mendelian randomization study. Hypertension. 2020;76(6):1971-1979.
23. Jones DW, et al. 2025
AHA/ACC/AANP/AAPA/ABC/ACCP/ACPM/AGS/AMA/ASPC/NMA/PCNA/SGIM
Guideline for the Prevention, Detection, Evaluation and Management
of High Blood Pressure in Adults: A Report of the American College
of Cardiology/American Heart Association Joint Committee on
Clinical Practice Guidelines. Circulation 2025;152:e114-e218.
24. Freeman MW, et al. Results from a phase
1, randomized, double-blind, multiple ascending dose study
characterizing the pharmacokinetics and demonstrating the safety
and selectivity of the aldosterone synthase inhibitor baxdrostat in
healthy volunteers. Hypertens
Res. 2023;46(1):108-118.
25. Freeman MW, et al. Phase 2 trial of
baxdrostat for treatment-resistant hypertension. N Engl J
Med. 2023;388(5):395-405.
26.
ClinicalTrials.gov. A Study to Assess Efficacy and Safety of
Baxdrostat in Participants With Primary Aldosteronism (BaxPA).
Available at: https://clinicaltrials.gov/study/NCT07007793.
Accessed April 2026.
27.
ClinicalTrials.gov. A Phase III Study to Investigate the Efficacy
and Safety of Baxdrostat in Combination With Dapagliflozin on CKD
Progression in Participants With CKD and High Blood Pressure.
Available at: https://clinicaltrials.gov/study/NCT06268873.
Accessed April 2026.
28.
ClinicalTrials.gov. A Phase III Renal Outcomes and Cardiovascular
Mortality Study to Investigate the Efficacy and Safety of
Baxdrostat in Combination With Dapagliflozin in Participants With
Chronic Kidney Disease and High Blood Pressure (BaxDuo-Pacific).
Available at: https://clinicaltrials.gov/study/NCT06742723.
Accessed April 2026.
29.
ClinicalTrials.gov. Phase III Study Investigating Heart Failure and
Cardiovascular Death With Baxdrostat in Combination With
Dapagliflozin (Prevent-HF). Available at:
https://clinicaltrials.gov/study/NCT06677060. Accessed April
2026.
30.
ClinicalTrials.gov. A Study to Investigate the Effect of Baxdrostat
on Ambulatory Blood Pressure in Participants With Resistant
Hypertension (Bax24). Available at:
https://clinicaltrials.gov/study/NCT06168409. Accessed April
2026.
31. Azizi M, Bax24 investigators, et
al. Effect of baxdrostat on ambulatory blood pressure in
patients with resistant hypertension (Bax24): a phase 3,
randomised, double-blind, placebo-controlled
trial. Lancet. 2026 Mar
7;407(10532):988-999.
32.
AstraZeneca 2023. Acquisition of CinCor Pharma complete. Available
at:
https://www.astrazeneca.com/media-centre/press-releases/2023/astrazeneca-acquires-cincor-for-cardiorenal-asset.html.
Accessed April 2026.
Matthew Bowden
Company Secretary
AstraZeneca PLC
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorized.
Date: 18 May 2026
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By: /s/
Matthew Bowden
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Name:
Matthew Bowden
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Title:
Company Secretary
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