AstraZeneca Scores Key FDA Wins Across Cardiovascular And Oncology Portfolios

On Monday, the U.S. Food and Drug Administration (FDA) approved AstraZeneca Plc's (NASDAQ: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. (NASDAQ: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 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 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 added that the approvals will trigger $155 million in milestone payments to Daiichi Sankyo under the companies' collaboration agreement.

AZN Price Action: AstraZeneca 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