---
title: "AstraZeneca Scores Key FDA Wins Across Cardiovascular And Oncology Portfolios"
type: "News"
locale: "en"
url: "https://longbridge.com/en/news/286801629.md"
description: "AstraZeneca received FDA approvals for Baxfendy, a hypertension treatment, and Enhertu for early HER2-positive breast cancer. Baxfendy targets uncontrolled hypertension, while Enhertu's approvals cover neoadjuvant and adjuvant settings. These milestones will result in $155 million payments to Daiichi Sankyo. AstraZeneca shares rose 1.56% to $184.42, despite a 9.1% decline over the past month."
datetime: "2026-05-18T16:59:00.000Z"
locales:
  - [zh-CN](https://longbridge.com/zh-CN/news/286801629.md)
  - [en](https://longbridge.com/en/news/286801629.md)
  - [zh-HK](https://longbridge.com/zh-HK/news/286801629.md)
---

# AstraZeneca Scores Key FDA Wins Across Cardiovascular And Oncology Portfolios

On Monday, the U.S. Food and Drug Administration (FDA) approved **AstraZeneca Plc's ( AZN )** Baxfendy (baxdrostat), a first-in-class aldosterone synthase inhibitor, for adults with hypertension whose blood pressure remains uncontrolled despite taking other antihypertensive medicines.

**Mineralys Therapeutics Inc. ( MLYS )** also has lorundrostat under FDA review for hypertension, with a decision date of 22 December.

## AstraZeneca Secures FDA Approval For Baxfendy In Hypertension

The company also announced expanded FDA approvals for Enhertu in HER2-positive early breast cancer alongside partner Daiichi Sankyo.

Baxfendy is designed to lower blood pressure by selectively blocking aldosterone production, a hormone linked to elevated blood pressure and increased cardiovascular and kidney risks.

AstraZeneca ( AZN ) said nearly half of U.S. patients already taking multiple hypertension drugs continue to experience uncontrolled blood pressure.

The approval was supported by results from the Phase 3 BaxHTN trial, where Baxfendy showed statistically significant reductions in seated systolic blood pressure at both 2mg and 1mg doses in patients taking at least two medications.

## Enhertu Gains Expanded Use In Early Breast Cancer

AstraZeneca ( AZN ) and Daiichi Sankyo also received FDA approvals for Enhertu (trastuzumab deruxtecan) in both neoadjuvant and adjuvant treatment settings for HER2-positive early breast cancer.

The approval in the neoadjuvant setting covers adults with Stage II or III HER2-positive breast cancer, while the adjuvant approval applies to patients with residual invasive disease following trastuzumab and taxane-based therapy.

In the DESTINY-Breast11 Phase 3 study, Enhertu followed by THP achieved a pathological complete response rate of 67.3%, compared with 56.3% for standard ddAC-THP treatment.

Meanwhile, the DESTINY-Breast05 trial showed that Enhertu reduced the risk of invasive disease recurrence or death by 53% versus trastuzumab emtansine in high-risk patients with residual disease.

AstraZeneca ( AZN ) added that the approvals will trigger $155 million in milestone payments to Daiichi Sankyo under the companies' collaboration agreement.

**AZN Price Action:** AstraZeneca ( AZN ) shares were up 1.56% at $184.42 at the time of publication on Monday, according to Benzinga Pro.

Over the past month, AZN has declined about 9.1% versus a 4.0% rise in the S&P 500 and is down roughly 0% year-to-date compared to the index's 7.5% gain.

_Photo: Shutterstock_

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- [Enhertu® Approved in the U.S. for Two New Indications for Patients with HER2 Positive Early Breast Cancer | AZN Stock News](https://longbridge.com/en/news/286621973.md)
- [FDA approves Enhertu for two HER2-positive early breast cancer indications](https://longbridge.com/en/news/286740066.md)
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- [<![CDATA[FDA Expands Enhertu in Early HER2-Positive Breast Cancer]]>](https://longbridge.com/en/news/286780814.md)