Ascendis Pharma stock zoomed higher Monday — closing in on a breakout — after the Food and Drug Administration signed off on its embattled hypoparathyroid disease drug.
The agency approved Yorvipath, Ascendis Pharma's hypoparathyroid treatment. Hypoparathyroidism occurs when one or more of the parathyroid glands isn't active enough. This causes an imbalance between two key minerals in the blood.
The approval comes after a "long regulatory path," Leerink Partners analyst Joseph Schwartz said.
The FDA initially rejected Yorvipath in April, citing the potential for dosing variability. Ascendis Pharma later resubmitted its application and received a May 14 decision date, only to have that pushed back by three months. The FDA deemed the resubmission a "major amendment" and needed more time to review it.
On today's stock market, Ascendis Pharma stock gained 1.2% to close at 128.48. Shares are consolidating with a buy point at 161, according to MarketSurge.
Ascendis Pharma: U.S. Launch Looming
Ascendis Pharma estimates there are 70,000 to 90,000 patients with hypoparathyroidism in the U.S. The company could officially launch the product in the fourth quarter of 2024 or the first quarter of 2025 depending on whether the FDA allows it to use already manufactured drug.
Yorvipath is already approved and its launch is underway in Germany and Austria. Sales in the first quarter were softer than expected. But "they are making great process penetrating their target physician base that could translate to more prescriptions," Leerink's Schwartz said in a report.
He kept his outperform rating on Ascendis Pharma stock.
Follow Allison Gatlin on X, the platform formerly known as Twitter, at @IBD_AGatlin.
