Monday was a good day for AstraZeneca. The FDA handed the company two big wins: one for a new hypertension drug and another for an expanded use of its blockbuster cancer therapy Enhertu. Let's break them down.

First up, the FDA approved AstraZeneca (AZN)'s Baxfendy (baxdrostat) for adults with high blood pressure that remains uncontrolled even after taking other antihypertensive medicines. Baxfendy is a first-in-class aldosterone synthase inhibitor, meaning it works by selectively blocking the production of aldosterone, a hormone that can raise blood pressure and increase cardiovascular and kidney risks. AstraZeneca noted that nearly half of U.S. patients on multiple hypertension drugs still have uncontrolled blood pressure, so there's a real need here. The approval was backed by the Phase 3 BaxHTN trial, where Baxfendy significantly reduced seated systolic blood pressure at both 2mg and 1mg doses in patients already on at least two medications.

Interestingly, Mineralys Therapeutics (MLYS) also has a similar drug, lorundrostat, under FDA review for hypertension, with a decision expected by December 22. So AstraZeneca got there first, but the race isn't over.

Now, the second win: Enhertu (trastuzumab deruxtecan), developed with Daiichi Sankyo, got FDA approvals for two new uses in HER2-positive early breast cancer. The neoadjuvant approval (treatment before surgery) covers adults with Stage II or III disease, while the adjuvant approval (after surgery) applies to patients with residual invasive disease after standard therapy. The data is impressive. In the DESTINY-Breast11 study, Enhertu followed by THP led to a pathological complete response rate of 67.3%, versus 56.3% for standard treatment. And in the DESTINY-Breast05 trial, Enhertu cut the risk of invasive disease recurrence or death by 53% compared to trastuzumab emtansine in high-risk patients with residual disease. These are meaningful numbers.

AstraZeneca said the approvals will trigger $155 million in milestone payments to Daiichi Sankyo under their collaboration agreement. That's the cost of doing business when you have a winner.

Investors seemed pleased. AstraZeneca shares were up 1.56% at $184.42 at the time of publication. But the stock has had a rough month, down about 9.1% versus a 4.0% rise in the S&P 500, and is roughly flat year-to-date compared to the index's 7.5% gain. So these approvals could be a nice catalyst to turn things around.