AstraZeneca Gains on FDA Fast Track for Hypertension Drug
The FDA's Priority Review for baxdrostat, a potential first-in-class therapy, could accelerate its path to a market with significant unmet medical need.
AstraZeneca PLC (NASDAQ: AZN) shares saw modest gains Tuesday after the U.S. Food and Drug Administration (FDA) accepted its New Drug Application for baxdrostat and granted it Priority Review. The drug is a potentially first-in-class therapy aimed at patients with hard-to-control hypertension, a significant development for the nearly $288 billion pharmaceutical giant.
Shares of the company traded up approximately 0.3% to $90.76 in afternoon trading. The FDA's Priority Review designation is a significant regulatory milestone that accelerates the review timeline. The agency's goal for a priority drug is to take action on an application within six months, compared to the standard 10-month review period. This decision signals the agency believes the drug could provide a significant improvement in the treatment of a serious condition.
Baxdrostat, an aldosterone synthase inhibitor, works through a novel mechanism to reduce blood pressure. If approved, it would be the first new class of hypertension medication in decades, targeting a patient population whose blood pressure remains high despite treatment with multiple existing drugs. This difficult-to-treat segment of the population represents a substantial unmet medical need and a considerable commercial opportunity.
Analysts have been optimistic about the drug's potential, with some projecting peak annual sales exceeding $5 billion by 2030. The enthusiasm is backed by robust clinical data. AstraZeneca previously announced that baxdrostat met its primary endpoint in Phase III trials, demonstrating a statistically significant and clinically meaningful reduction in systolic blood pressure for patients with uncontrolled hypertension.
The therapy is a key component of AstraZeneca's growing cardiovascular and metabolic diseases portfolio, an area where the company continues to invest heavily alongside its well-known oncology division. The development of baxdrostat originated with AstraZeneca's acquisition of CinCor Pharma in 2023, a deal valued at up to $1.8 billion, which was centered on gaining control of the promising hypertension candidate.
The competitive landscape for novel hypertension treatments is heating up. If approved, baxdrostat would compete with other new entrants, including Idorsia's Tryvio (aprocitentan), which was approved last year, and Mineralys Therapeutics' lorundrostat. However, analysts believe baxdrostat's distinct mechanism of action could allow it to carve out a significant share of the market.
Wall Street remains broadly positive on AstraZeneca's outlook. The consensus among analysts is a 'Buy' rating, with a majority recommending either 'Buy' or 'Strong Buy' and an average price target of approximately $94.68, suggesting further upside from its current trading level. The company's pipeline and consistent execution have made it a favored name among large-cap pharmaceutical stocks.
With the FDA's Priority Review now in place, the next major catalyst for AstraZeneca and baxdrostat will be the Prescription Drug User Fee Act (PDUFA) date, which sets the deadline for the agency's approval decision. This is now expected in the first half of next year, setting the stage for a potential commercial launch and a new revenue stream for the British-Swedish multinational.