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[6-K] AstraZeneca PLC Current Report (Foreign Issuer)

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AstraZeneca (AZN) reports that baxdrostat, its orally administered, first-in-class aldosterone synthase inhibitor, met the primary and all secondary endpoints in the pivotal Phase III BaxHTN trial involving 796 patients with uncontrolled or treatment-resistant hypertension. At both 2 mg and 1 mg doses, baxdrostat produced a statistically significant, clinically meaningful reduction in mean seated systolic blood pressure (SBP) at 12 weeks versus placebo when added to standard of care. The compound was “generally well tolerated” and showed a favourable safety profile. Additional endpoints—including diastolic BP, SBP in the resistant-hypertension subgroup, proportion of patients achieving SBP <130 mmHg, and persistence of effect during a randomised withdrawal period—were all achieved.

The BaxHTN study comprises three components: (1) a 12-week double-blind efficacy period, (2) an 8-week withdrawal test of durability, and (3) a 52-week safety follow-up. Data will be shared with regulators worldwide and presented during a late-breaking Hot Line session at the European Society of Cardiology Congress in August 2025.

Hypertension affects 1.3 billion people globally, and roughly half of U.S. patients on multiple drugs remain uncontrolled, underlining the addressable market. By specifically targeting aldosterone—implicated in difficult-to-manage hypertension—baxdrostat introduces a novel mechanism to a therapeutic area with limited innovation in two decades.

AstraZeneca obtained baxdrostat through its February 2023 acquisition of CinCor Pharma; a contingent value right of $10 per CinCor share (≈$0.5 billion) becomes payable upon NDA/MAA submission. Positive Phase III results substantially de-risk that milestone and accelerate the path toward regulatory filings.

AstraZeneca (AZN) comunica che baxdrostat, il suo inibitore orale di sintesi dell'aldosterone di prima classe, ha raggiunto gli endpoints primari e tutti gli endpoints secondari nello studio cardine di Fase III BaxHTN, che ha coinvolto 796 pazienti con ipertensione non controllata o resistente al trattamento. A entrambe le dosi di 2 mg e 1 mg, baxdrostat ha prodotto una riduzione statisticamente significativa e clinicamente rilevante della pressione sistolica media in posizione seduta (SBP) a 12 settimane rispetto al placebo, quando aggiunto alla terapia standard. Il composto è stato "generalmente ben tollerato" e ha mostrato un profilo di sicurezza favorevole. Sono stati raggiunti anche altri endpoints, tra cui la pressione diastolica, la SBP nel sottogruppo con ipertensione resistente, la percentuale di pazienti con SBP <130 mmHg e la persistenza dell'effetto durante un periodo di ritiro randomizzato.

Lo studio BaxHTN comprende tre fasi: (1) un periodo di efficacia in doppio cieco di 12 settimane, (2) un test di ritiro di 8 settimane per valutare la durata dell'effetto, e (3) un follow-up di sicurezza di 52 settimane. I dati saranno condivisi con le autorità regolatorie a livello globale e presentati durante una sessione Hot Line a presentazione tardiva al Congresso della Società Europea di Cardiologia nell'agosto 2025.

L'ipertensione colpisce 1,3 miliardi di persone nel mondo e circa la metà dei pazienti statunitensi in terapia multipla rimane non controllata, evidenziando un mercato significativo. Baxdrostat, agendo specificamente sull'aldosterone, coinvolto nell'ipertensione difficile da trattare, introduce un meccanismo innovativo in un'area terapeutica con limitate novità negli ultimi vent'anni.

AstraZeneca ha acquisito baxdrostat tramite l'acquisizione di CinCor Pharma nel febbraio 2023; un diritto di valore contingente di 10 dollari per azione CinCor (circa 0,5 miliardi di dollari) sarà pagabile al momento della presentazione della NDA/MAA. I risultati positivi della Fase III riducono significativamente il rischio legato a questo traguardo e accelerano il percorso verso le richieste regolatorie.

AstraZeneca (AZN) informa que baxdrostat, su inhibidor de la aldosterona sintasa de primera clase administrado por vía oral, cumplió con los endpoints primarios y todos los secundarios en el ensayo pivotal de Fase III BaxHTN, que incluyó a 796 pacientes con hipertensión no controlada o resistente al tratamiento. Tanto en dosis de 2 mg como de 1 mg, baxdrostat produjo una reducción estadísticamente significativa y clínicamente relevante de la presión arterial sistólica media en posición sentada (SBP) a las 12 semanas frente a placebo cuando se añadió al tratamiento estándar. El compuesto fue “generalmente bien tolerado” y mostró un perfil de seguridad favorable. Se lograron también otros endpoints, incluyendo la presión arterial diastólica, la SBP en el subgrupo con hipertensión resistente, la proporción de pacientes que alcanzaron SBP <130 mmHg y la persistencia del efecto durante un período de retirada aleatorizado.

El estudio BaxHTN consta de tres partes: (1) un período de eficacia doble ciego de 12 semanas, (2) una prueba de retirada de 8 semanas para evaluar la durabilidad, y (3) un seguimiento de seguridad de 52 semanas. Los datos se compartirán con los reguladores a nivel mundial y se presentarán en una sesión Hot Line de última hora en el Congreso de la Sociedad Europea de Cardiología en agosto de 2025.

La hipertensión afecta a 1.300 millones de personas en todo el mundo, y aproximadamente la mitad de los pacientes estadounidenses en tratamiento múltiple permanecen sin control, lo que destaca un mercado importante. Baxdrostat, al dirigirse específicamente a la aldosterona, implicada en la hipertensión difícil de tratar, introduce un mecanismo novedoso en un área terapéutica con poca innovación en dos décadas.

AstraZeneca obtuvo baxdrostat mediante la adquisición de CinCor Pharma en febrero de 2023; un derecho contingente de valor de 10 dólares por acción de CinCor (≈0,5 mil millones de dólares) será pagadero al momento de la presentación de la NDA/MAA. Los resultados positivos de la Fase III reducen sustancialmente el riesgo asociado a este hito y aceleran el camino hacia las solicitudes regulatorias.

AstraZeneca(AZN)는 경구 투여하는 최초의 알도스테론 합성 효소 억제제인 baxdrostat가 796명의 통제되지 않거나 치료 저항성 고혈압 환자를 대상으로 한 주요 3상 BaxHTN 임상시험에서 주요모든 2차 평가변수를 충족했다고 발표했습니다. 2mg 및 1mg 용량 모두에서 baxdrostat는 표준 치료에 추가했을 때 12주 후 위약 대비 평균 앉은 상태 수축기 혈압(SBP)을 통계적으로 유의미하고 임상적으로 의미 있게 감소시켰습니다. 약물은 “일반적으로 잘 견디는” 것으로 나타났으며 안전성 프로파일도 우수했습니다. 이외에도 이완기 혈압, 저항성 고혈압 하위 그룹의 SBP, SBP가 130mmHg 미만인 환자 비율, 무작위 중단 기간 동안 효과 지속성 등 추가 평가변수도 모두 달성되었습니다.

BaxHTN 연구는 세 부분으로 구성됩니다: (1) 12주간 이중맹검 효능 평가 기간, (2) 8주간 내구성 평가를 위한 중단 시험, (3) 52주간 안전성 추적 관찰. 데이터는 전 세계 규제 당국과 공유되며 2025년 8월 유럽심장학회 학술대회에서 핫라인 세션을 통해 발표될 예정입니다.

고혈압은 전 세계적으로 13억 명 이상에게 영향을 미치며, 미국 내 다중 약물 치료 환자의 약 절반이 혈압이 조절되지 않고 있어 시장의 잠재력이 큽니다. 알도스테론을 표적으로 삼아 치료가 어려운 고혈압에 관여하는 baxdrostat는 지난 20년간 혁신이 제한적이었던 치료 분야에 새로운 작용 기전을 도입합니다.

AstraZeneca는 2023년 2월 CinCor Pharma 인수를 통해 baxdrostat를 확보했으며, NDA/MAA 제출 시점에 CinCor 주식 1주당 10달러(약 5억 달러)의 조건부 가치 권리가 지급됩니다. 3상 긍정적 결과는 이 마일스톤의 위험을 크게 낮추고 규제 신청 절차를 가속화합니다.

AstraZeneca (AZN) annonce que baxdrostat, son inhibiteur oral de synthèse de l’aldostérone de première classe, a atteint les critères principaux et tous les critères secondaires lors de l’essai pivot de Phase III BaxHTN impliquant 796 patients souffrant d’hypertension non contrôlée ou résistante au traitement. Aux doses de 2 mg et 1 mg, baxdrostat a entraîné une réduction statistiquement significative et cliniquement pertinente de la pression artérielle systolique moyenne en position assise (PAS) à 12 semaines par rapport au placebo lorsqu’il était ajouté au traitement standard. Le composé a été « généralement bien toléré » et a présenté un profil de sécurité favorable. D’autres critères, notamment la pression artérielle diastolique, la PAS dans le sous-groupe d’hypertension résistante, la proportion de patients atteignant une PAS <130 mmHg, ainsi que la persistance de l’effet pendant une période de retrait randomisée, ont tous été atteints.

L’étude BaxHTN comprend trois volets : (1) une période d’efficacité en double aveugle de 12 semaines, (2) un test de retrait de 8 semaines pour évaluer la durabilité, et (3) un suivi de sécurité de 52 semaines. Les données seront partagées avec les autorités réglementaires du monde entier et présentées lors d’une session Hot Line de dernière minute au Congrès de la Société Européenne de Cardiologie en août 2025.

L’hypertension touche 1,3 milliard de personnes dans le monde, et environ la moitié des patients américains sous traitement multiple restent non contrôlés, ce qui souligne un marché important. En ciblant spécifiquement l’aldostérone, impliquée dans l’hypertension difficile à traiter, baxdrostat introduit un mécanisme innovant dans un domaine thérapeutique où l’innovation est limitée depuis deux décennies.

AstraZeneca a obtenu baxdrostat grâce à l’acquisition de CinCor Pharma en février 2023 ; un droit de valeur conditionnel de 10 $ par action CinCor (≈0,5 milliard de dollars) sera versé lors du dépôt de la NDA/MAA. Les résultats positifs de la Phase III réduisent considérablement ce risque et accélèrent la voie vers les dossiers réglementaires.

AstraZeneca (AZN) berichtet, dass baxdrostat, ihr oral verabreichter, neuartiger Aldosteron-Synthase-Inhibitor, die primären und alle sekundären Endpunkte in der entscheidenden Phase-III-Studie BaxHTN mit 796 Patienten mit unbehandeltem oder therapieresistentem Bluthochdruck erreicht hat. Sowohl bei 2 mg als auch bei 1 mg Dosis führte baxdrostat zu einer statistisch signifikanten und klinisch relevanten Senkung des mittleren sitzenden systolischen Blutdrucks (SBP) nach 12 Wochen im Vergleich zu Placebo, wenn es zur Standardtherapie hinzugefügt wurde. Die Substanz wurde „allgemein gut vertragen“ und zeigte ein günstiges Sicherheitsprofil. Weitere Endpunkte – einschließlich diastolischem Blutdruck, SBP in der resistenten Hypertonie-Subgruppe, Anteil der Patienten mit SBP <130 mmHg und Persistenz des Effekts während einer randomisierten Absetzphase – wurden ebenfalls erreicht.

Die BaxHTN-Studie umfasst drei Teile: (1) eine 12-wöchige doppelblinde Wirksamkeitsphase, (2) einen 8-wöchigen Absetzer-Test zur Dauerhaftigkeit, und (3) eine 52-wöchige Sicherheitsnachbeobachtung. Die Daten werden weltweit mit Regulierungsbehörden geteilt und im August 2025 in einer Late-Breaking-Hot-Line-Sitzung beim Kongress der Europäischen Gesellschaft für Kardiologie präsentiert.

Bluthochdruck betrifft 1,3 Milliarden Menschen weltweit, und etwa die Hälfte der US-Patienten unter Mehrfachtherapie bleibt unkontrolliert, was den adressierbaren Markt unterstreicht. Durch die gezielte Wirkung auf Aldosteron – das bei schwer behandelbarem Bluthochdruck eine Rolle spielt – bringt baxdrostat einen neuartigen Wirkmechanismus in ein Therapiefeld mit begrenzter Innovation in zwei Jahrzehnten.

AstraZeneca erwarb baxdrostat durch die Übernahme von CinCor Pharma im Februar 2023; ein bedingtes Wertrecht von 10 USD pro CinCor-Aktie (≈0,5 Mrd. USD) wird bei Einreichung der NDA/MAA fällig. Positive Phase-III-Ergebnisse verringern dieses Risiko erheblich und beschleunigen den Weg zu den Zulassungsanträgen.

Positive
  • All primary and secondary endpoints met in Phase III BaxHTN trial, validating efficacy across two doses.
  • Clinically meaningful SBP reduction vs. placebo, addressing large unmet need in uncontrolled/resistant hypertension.
  • Favourable safety/tolerability profile supports chronic use and regulatory acceptance.
  • Data to be presented at ESC Congress 2025, increasing scientific visibility and momentum toward filing.
  • Progress triggers path to regulatory submissions, advancing potential commercial launch.
Negative
  • $0.5 billion contingent value right becomes payable upon NDA/MAA submission, adding near-term cash outflow.
  • Regulatory approval and market uptake remain uncertain future hurdles despite positive data.

Insights

TL;DR: Phase III success validates baxdrostat’s novel mechanism and positions AZN for a potentially high-value hypertension launch; regulatory and CVR costs remain next hurdles.

The BaxHTN read-out confirms efficacy at both tested doses, achieving all predefined endpoints—an outcome that materially reduces clinical risk and supports rapid NDA preparation. Given the 1.3 billion-patient prevalence and unmet need in resistant hypertension, commercial potential is meaningful, particularly as current therapies leave ~50% of U.S. patients uncontrolled. Safety was "generally well tolerated," crucial for a chronic indication. The $0.5 billion CVR tied to CinCor adds a manageable near-term cash outlay but does not alter AZN’s balance-sheet strength. Presentation at ESC 2025 will provide detailed data; any safety signals emerging there would be an important watch-point. Overall, the news is positive and impactful.

TL;DR: Clinically meaningful BP reduction and clean safety profile boost AZN growth optionality; hypertension market scale implies multi-billion potential.

Success in Phase III places baxdrostat among AZN’s next growth drivers within its CVRM franchise. A first-in-class label could command premium pricing and broad uptake, especially in treatment-resistant cohorts. The favourable safety data lessen reimbursement and adoption barriers. Milestone CVR payment is modest relative to upside. With data going to regulators shortly, timeline risk shortens, increasing NPV. I classify the disclosure as highly impactful for long-term valuation.

AstraZeneca (AZN) comunica che baxdrostat, il suo inibitore orale di sintesi dell'aldosterone di prima classe, ha raggiunto gli endpoints primari e tutti gli endpoints secondari nello studio cardine di Fase III BaxHTN, che ha coinvolto 796 pazienti con ipertensione non controllata o resistente al trattamento. A entrambe le dosi di 2 mg e 1 mg, baxdrostat ha prodotto una riduzione statisticamente significativa e clinicamente rilevante della pressione sistolica media in posizione seduta (SBP) a 12 settimane rispetto al placebo, quando aggiunto alla terapia standard. Il composto è stato "generalmente ben tollerato" e ha mostrato un profilo di sicurezza favorevole. Sono stati raggiunti anche altri endpoints, tra cui la pressione diastolica, la SBP nel sottogruppo con ipertensione resistente, la percentuale di pazienti con SBP <130 mmHg e la persistenza dell'effetto durante un periodo di ritiro randomizzato.

Lo studio BaxHTN comprende tre fasi: (1) un periodo di efficacia in doppio cieco di 12 settimane, (2) un test di ritiro di 8 settimane per valutare la durata dell'effetto, e (3) un follow-up di sicurezza di 52 settimane. I dati saranno condivisi con le autorità regolatorie a livello globale e presentati durante una sessione Hot Line a presentazione tardiva al Congresso della Società Europea di Cardiologia nell'agosto 2025.

L'ipertensione colpisce 1,3 miliardi di persone nel mondo e circa la metà dei pazienti statunitensi in terapia multipla rimane non controllata, evidenziando un mercato significativo. Baxdrostat, agendo specificamente sull'aldosterone, coinvolto nell'ipertensione difficile da trattare, introduce un meccanismo innovativo in un'area terapeutica con limitate novità negli ultimi vent'anni.

AstraZeneca ha acquisito baxdrostat tramite l'acquisizione di CinCor Pharma nel febbraio 2023; un diritto di valore contingente di 10 dollari per azione CinCor (circa 0,5 miliardi di dollari) sarà pagabile al momento della presentazione della NDA/MAA. I risultati positivi della Fase III riducono significativamente il rischio legato a questo traguardo e accelerano il percorso verso le richieste regolatorie.

AstraZeneca (AZN) informa que baxdrostat, su inhibidor de la aldosterona sintasa de primera clase administrado por vía oral, cumplió con los endpoints primarios y todos los secundarios en el ensayo pivotal de Fase III BaxHTN, que incluyó a 796 pacientes con hipertensión no controlada o resistente al tratamiento. Tanto en dosis de 2 mg como de 1 mg, baxdrostat produjo una reducción estadísticamente significativa y clínicamente relevante de la presión arterial sistólica media en posición sentada (SBP) a las 12 semanas frente a placebo cuando se añadió al tratamiento estándar. El compuesto fue “generalmente bien tolerado” y mostró un perfil de seguridad favorable. Se lograron también otros endpoints, incluyendo la presión arterial diastólica, la SBP en el subgrupo con hipertensión resistente, la proporción de pacientes que alcanzaron SBP <130 mmHg y la persistencia del efecto durante un período de retirada aleatorizado.

El estudio BaxHTN consta de tres partes: (1) un período de eficacia doble ciego de 12 semanas, (2) una prueba de retirada de 8 semanas para evaluar la durabilidad, y (3) un seguimiento de seguridad de 52 semanas. Los datos se compartirán con los reguladores a nivel mundial y se presentarán en una sesión Hot Line de última hora en el Congreso de la Sociedad Europea de Cardiología en agosto de 2025.

La hipertensión afecta a 1.300 millones de personas en todo el mundo, y aproximadamente la mitad de los pacientes estadounidenses en tratamiento múltiple permanecen sin control, lo que destaca un mercado importante. Baxdrostat, al dirigirse específicamente a la aldosterona, implicada en la hipertensión difícil de tratar, introduce un mecanismo novedoso en un área terapéutica con poca innovación en dos décadas.

AstraZeneca obtuvo baxdrostat mediante la adquisición de CinCor Pharma en febrero de 2023; un derecho contingente de valor de 10 dólares por acción de CinCor (≈0,5 mil millones de dólares) será pagadero al momento de la presentación de la NDA/MAA. Los resultados positivos de la Fase III reducen sustancialmente el riesgo asociado a este hito y aceleran el camino hacia las solicitudes regulatorias.

AstraZeneca(AZN)는 경구 투여하는 최초의 알도스테론 합성 효소 억제제인 baxdrostat가 796명의 통제되지 않거나 치료 저항성 고혈압 환자를 대상으로 한 주요 3상 BaxHTN 임상시험에서 주요모든 2차 평가변수를 충족했다고 발표했습니다. 2mg 및 1mg 용량 모두에서 baxdrostat는 표준 치료에 추가했을 때 12주 후 위약 대비 평균 앉은 상태 수축기 혈압(SBP)을 통계적으로 유의미하고 임상적으로 의미 있게 감소시켰습니다. 약물은 “일반적으로 잘 견디는” 것으로 나타났으며 안전성 프로파일도 우수했습니다. 이외에도 이완기 혈압, 저항성 고혈압 하위 그룹의 SBP, SBP가 130mmHg 미만인 환자 비율, 무작위 중단 기간 동안 효과 지속성 등 추가 평가변수도 모두 달성되었습니다.

BaxHTN 연구는 세 부분으로 구성됩니다: (1) 12주간 이중맹검 효능 평가 기간, (2) 8주간 내구성 평가를 위한 중단 시험, (3) 52주간 안전성 추적 관찰. 데이터는 전 세계 규제 당국과 공유되며 2025년 8월 유럽심장학회 학술대회에서 핫라인 세션을 통해 발표될 예정입니다.

고혈압은 전 세계적으로 13억 명 이상에게 영향을 미치며, 미국 내 다중 약물 치료 환자의 약 절반이 혈압이 조절되지 않고 있어 시장의 잠재력이 큽니다. 알도스테론을 표적으로 삼아 치료가 어려운 고혈압에 관여하는 baxdrostat는 지난 20년간 혁신이 제한적이었던 치료 분야에 새로운 작용 기전을 도입합니다.

AstraZeneca는 2023년 2월 CinCor Pharma 인수를 통해 baxdrostat를 확보했으며, NDA/MAA 제출 시점에 CinCor 주식 1주당 10달러(약 5억 달러)의 조건부 가치 권리가 지급됩니다. 3상 긍정적 결과는 이 마일스톤의 위험을 크게 낮추고 규제 신청 절차를 가속화합니다.

AstraZeneca (AZN) annonce que baxdrostat, son inhibiteur oral de synthèse de l’aldostérone de première classe, a atteint les critères principaux et tous les critères secondaires lors de l’essai pivot de Phase III BaxHTN impliquant 796 patients souffrant d’hypertension non contrôlée ou résistante au traitement. Aux doses de 2 mg et 1 mg, baxdrostat a entraîné une réduction statistiquement significative et cliniquement pertinente de la pression artérielle systolique moyenne en position assise (PAS) à 12 semaines par rapport au placebo lorsqu’il était ajouté au traitement standard. Le composé a été « généralement bien toléré » et a présenté un profil de sécurité favorable. D’autres critères, notamment la pression artérielle diastolique, la PAS dans le sous-groupe d’hypertension résistante, la proportion de patients atteignant une PAS <130 mmHg, ainsi que la persistance de l’effet pendant une période de retrait randomisée, ont tous été atteints.

L’étude BaxHTN comprend trois volets : (1) une période d’efficacité en double aveugle de 12 semaines, (2) un test de retrait de 8 semaines pour évaluer la durabilité, et (3) un suivi de sécurité de 52 semaines. Les données seront partagées avec les autorités réglementaires du monde entier et présentées lors d’une session Hot Line de dernière minute au Congrès de la Société Européenne de Cardiologie en août 2025.

L’hypertension touche 1,3 milliard de personnes dans le monde, et environ la moitié des patients américains sous traitement multiple restent non contrôlés, ce qui souligne un marché important. En ciblant spécifiquement l’aldostérone, impliquée dans l’hypertension difficile à traiter, baxdrostat introduit un mécanisme innovant dans un domaine thérapeutique où l’innovation est limitée depuis deux décennies.

AstraZeneca a obtenu baxdrostat grâce à l’acquisition de CinCor Pharma en février 2023 ; un droit de valeur conditionnel de 10 $ par action CinCor (≈0,5 milliard de dollars) sera versé lors du dépôt de la NDA/MAA. Les résultats positifs de la Phase III réduisent considérablement ce risque et accélèrent la voie vers les dossiers réglementaires.

AstraZeneca (AZN) berichtet, dass baxdrostat, ihr oral verabreichter, neuartiger Aldosteron-Synthase-Inhibitor, die primären und alle sekundären Endpunkte in der entscheidenden Phase-III-Studie BaxHTN mit 796 Patienten mit unbehandeltem oder therapieresistentem Bluthochdruck erreicht hat. Sowohl bei 2 mg als auch bei 1 mg Dosis führte baxdrostat zu einer statistisch signifikanten und klinisch relevanten Senkung des mittleren sitzenden systolischen Blutdrucks (SBP) nach 12 Wochen im Vergleich zu Placebo, wenn es zur Standardtherapie hinzugefügt wurde. Die Substanz wurde „allgemein gut vertragen“ und zeigte ein günstiges Sicherheitsprofil. Weitere Endpunkte – einschließlich diastolischem Blutdruck, SBP in der resistenten Hypertonie-Subgruppe, Anteil der Patienten mit SBP <130 mmHg und Persistenz des Effekts während einer randomisierten Absetzphase – wurden ebenfalls erreicht.

Die BaxHTN-Studie umfasst drei Teile: (1) eine 12-wöchige doppelblinde Wirksamkeitsphase, (2) einen 8-wöchigen Absetzer-Test zur Dauerhaftigkeit, und (3) eine 52-wöchige Sicherheitsnachbeobachtung. Die Daten werden weltweit mit Regulierungsbehörden geteilt und im August 2025 in einer Late-Breaking-Hot-Line-Sitzung beim Kongress der Europäischen Gesellschaft für Kardiologie präsentiert.

Bluthochdruck betrifft 1,3 Milliarden Menschen weltweit, und etwa die Hälfte der US-Patienten unter Mehrfachtherapie bleibt unkontrolliert, was den adressierbaren Markt unterstreicht. Durch die gezielte Wirkung auf Aldosteron – das bei schwer behandelbarem Bluthochdruck eine Rolle spielt – bringt baxdrostat einen neuartigen Wirkmechanismus in ein Therapiefeld mit begrenzter Innovation in zwei Jahrzehnten.

AstraZeneca erwarb baxdrostat durch die Übernahme von CinCor Pharma im Februar 2023; ein bedingtes Wertrecht von 10 USD pro CinCor-Aktie (≈0,5 Mrd. USD) wird bei Einreichung der NDA/MAA fällig. Positive Phase-III-Ergebnisse verringern dieses Risiko erheblich und beschleunigen den Weg zu den Zulassungsanträgen.

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 July 2025 
 
Commission File Number: 001-11960
 
AstraZeneca PLC
 
1 Francis Crick Avenue
Cambridge Biomedical Campus
Cambridge CB2 0AA
United Kingdom
 
 
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
 
Form 20-F X Form 40-F __
 
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):
 
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ______
 
Indicate by check mark whether the registrant by furnishing the information contained in this Form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.
 
Yes __                               No X
 
If “Yes” is marked, indicate below the file number assigned to the Registrant in connection with Rule 12g3-2(b): 82-_____________
 
 
 
 
 
AstraZeneca PLC
 
INDEX TO EXHIBITS
 
1.
Baxdrostat met primary endpt in BaxHTN PhIII trial
 
This announcement contains inside information
 
14 July 2025
 
Baxdrostat met the primary and all secondary endpoints in BaxHTN Phase III trial in patients with uncontrolled or treatment resistant hypertension
 
Baxdrostat demonstrated a statistically significant and clinically meaningful reduction of systolic blood pressure compared with placebo 
 
Positive high-level results from the BaxHTN Phase III trial showed baxdrostat at two doses (2mg and 1mg) demonstrated a statistically significant and clinically meaningful reduction in mean seated systolic blood pressure (SBP) compared with placebo at 12 weeks. The trial also successfully met all secondary endpoints. Patients with uncontrolled or treatment resistant hypertension received baxdrostat or placebo on top of standard of care. Baxdrostat was generally well tolerated with a favourable safety profile.
 
There are 1.3 billion people worldwide living with hypertension.1 When uncontrolled, hypertension can lead to a higher risk of heart attack, stroke, heart failure and kidney disease.2,3 In the US, approximately 50% of hypertensive patients who are on multiple treatments do not have their blood pressure under control.4 Growing evidence points to aldosterone dysregulation as one of the key biological drivers of hypertension.5,6
 
Dr. Bryan Williams, Chair of Medicine at University College London, primary investigator, said: “Many people continue to struggle with high blood pressure that is hard to control, even when taking multiple medications. The highly promising BaxHTN Phase III results show that once-daily baxdrostat on top of standard of care can meaningfully lower systolic blood pressure and offer a potential new treatment approach for controlling hypertension, the leading risk factor for cardiovascular disease.” 
 
Sharon Barr, Executive Vice President, BioPharmaceuticals R&D, said: “We are very excited with the BaxHTN Phase III results, which show statistically significant and clinically meaningful reductions in systolic blood pressure. These findings provide compelling evidence of baxdrostat’s potential to address a critical unmet need by targeting aldosterone dysregulation, bringing a novel mechanism to a field that has seen little innovation in over two decades.”
 
BaxHTN is a Phase III, multicentre, randomised, double-blinded, placebo-controlled, parallel group study to evaluate the safety, tolerability and effect of baxdrostat in patients with uncontrolled hypertension being treated with two different antihypertensive medications and patients with resistant hypertension being treated with three or more different antihypertensive medications, one of which is a diuretic.7
 
The data will be shared with regulatory authorities around the world and presented in a late-breaking Hot Line session at the European Society of Cardiology (ESC) Congress in August 2025.
 
Baxdrostat is a potential first-in-class, highly selective aldosterone synthase inhibitor (ASI) that targets the hormone driving elevated blood pressure and increased cardiovascular and renal risk. It is currently being investigated in clinical trials as a monotherapy for hypertension8,9 and primary aldosteronism,10 and in combination with dapagliflozin for chronic kidney disease and the prevention of heart failure in high-risk hypertensive patients.11-13
 
Notes
 
Hypertension that is hard to control
Hypertension is a medical condition characterised by consistently high blood pressure levels.2,3 Over time, this can damage blood vessels and vital organs, increasing the risk of serious health problems.2,3 Hypertension that is hard to control remains a significant public health challenge.1 Despite lifestyle changes and the use of multiple medications, a significant majority of people with hypertension do not achieve their blood pressure goals.1,4 Uncontrolled hypertension persists despite treatment with two or more medications, while resistant hypertension, a more severe form, remains elevated despite treatment with three or more medications.2,4
 
A key contributor of hypertension that is hard to control is aldosterone, a hormone that increases blood pressure by promoting sodium and water retention.5,6 Elevated aldosterone levels, along with factors like obesity, high salt intake and various genetic and secondary conditions,14 are strongly linked to poor blood pressure control. If left untreated, the condition significantly increases the risk of heart attack, stroke and kidney decline.2,3
 
BaxHTN trial
The BaxHTN Phase III trial7 had three components to it that support the following endpoints: The primary endpoint was assessed during a 12-week double-blind, placebo-controlled period. A total of 796 patients were randomised in a 1:1:1 ratio to receive baxdrostat 2mg, 1mg or placebo once daily. 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 baxdrostat 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 baxdrostat 2mg dose. Long-term safety is assessed at the end of the 52 weeks compared to a standard of care arm.
 
Additional secondary endpoints include the effect of baxdrostat versus placebo on seated SBP at Week 12 in the resistant hypertension subpopulation, the effect of baxdrostat versus placebo on seated diastolic blood pressure at Week 12, participants achieving seated SBP less than 130 mmHg at Week 12 and occurrence of adverse events.
 
Baxdrostat
Baxdrostat is a potential first-in-class, highly selective and potent, oral, small molecule that inhibits aldosterone synthase,15 an enzyme encoded by the CYP11B2 gene, which is responsible for the synthesis of aldosterone in the adrenal gland.5 In clinical trials, baxdrostat was observed to significantly lower aldosterone levels without affecting cortisol levels across a wide range of doses.16,17 Baxdrostat is currently being investigated in clinical trials as a monotherapy for hypertension7-9 and primary aldosteronism,10 and in combination with dapagliflozin for chronic kidney disease11,12 and the prevention of heart failure in hypertensive patients.13
 
AstraZeneca acquired baxdrostat through its purchase of CinCor Pharma, Inc. in February 2023.18 A contingent value right of $10 per share in cash ($0.5 billion) is payable to former CinCor shareholders upon the submission of a new drug application either in the US or Europe.18
 
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/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases, 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.
NCD Risk Factor Collaboration (NCD-RisC). Worldwide trends in hypertension prevalence and progress in treatment and control from 1990 to 2019: a pooled analysis of 1201 population-representative studies with 104 million participants. Lancet. 2021;398(10304):957-980.
2.
McEvoy JW, et al. 2024 ESC Guidelines for the management of elevated blood pressure and hypertension. EurHeart J. 2024;45(38):3912-4018.
3.
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. 
4.
Carey RM, et al. Prevalence of apparent treatment-resistant hypertension in the United States: comparison of the 2008 and 2018 American Heart Association scientific statements on resistant hypertension [including online supplement]. Hypertension. 2019;73(2):424-431.
5.
Cannavo A, et al. Aldosterone and mineralocorticoid receptor system in cardiovascular physiology and pathophysiology. Oxid Med Cell Longev. 2018;2018:1204598. 
6.
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.
7.
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 June 2025.
8.
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 June 2025.
9.
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 (BaxAsia). Available at: https://clinicaltrials.gov/study/NCT06344104. Accessed June 2025.
10.
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 June 2025.
11.
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 June 2025.
12.
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 June 2025.
13.
ClinicalTrials.gov. A Phase III Study Investigating Heart Failure and Cardiovascular Death With Baxdrostat in Combination With Dapagliflozin (Prevent-HF). ClinicalTrials.gov identifier: NCT06677060. Available at: https://clinicaltrials.gov/study/NCT06677060. Accessed June 2025.
14.
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.
15.
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.
16.
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)108–118.
17.
Freeman MW, et al. Phase 2 Trial of Baxdrostat for Treatment-Resistant Hypertension. NEJM. 2023;388:395-405
18.
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 June 2025.
 
Matthew Bowden
Company Secretary
AstraZeneca PLC
 
This announcement contains information that AstraZeneca PLC is obliged to make public pursuant to the EU Market Abuse Regulation (596/2014) and the assimilated EU Market Abuse Regulation (596/2014) as it forms part of the law of the United Kingdom by operation of the European Union (Withdrawal) Act 2018. This announcement was submitted for publication, through the agency of the contact person(s) set out above, at 07:00 BST on 14 July 2025.
 
 
 
 
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.
 
 
AstraZeneca PLC
 
 
Date: 14 July 2025
 
 
By: /s/ Adrian Kemp
 
Name: Adrian Kemp
 
Title: Company Secretary

FAQ

What did AstraZeneca (AZN) announce in its July 2025 6-K?

AZN reported that baxdrostat met all primary and secondary endpoints in the Phase III BaxHTN hypertension trial with significant SBP reduction.

How effective was baxdrostat in the Phase III BaxHTN study?

Both 2 mg and 1 mg doses showed statistically significant, clinically meaningful seated systolic blood-pressure reductions at 12 weeks versus placebo.

Were there any safety concerns reported for baxdrostat?

The 6-K states baxdrostat was generally well tolerated with a favourable safety profile during the trial.

What is the financial impact of the CinCor contingent value right?

AstraZeneca must pay former CinCor shareholders $10 per share (about $0.5 billion) once an NDA or MAA for baxdrostat is filed.

When will detailed BaxHTN results be presented?

AZN plans to present the data in a late-breaking Hot Line session at the European Society of Cardiology Congress in August 2025.

What market need does baxdrostat address?

Up to 50% of U.S. patients on multiple hypertension drugs remain uncontrolled; baxdrostat’s aldosterone-targeting mechanism aims to fill this gap.
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