Get all your news in one place.
100’s of premium titles.
One app.
Start reading
Investors Business Daily
Investors Business Daily
Technology
ALLISON GATLIN

Ascendis Pharma Zips Higher After FDA Approves Embattled Drug

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.

Sign up to read this article
Read news from 100’s of titles, curated specifically for you.
Already a member? Sign in here
Related Stories
Top stories on inkl right now
One subscription that gives you access to news from hundreds of sites
Already a member? Sign in here
Our Picks
Fourteen days free
Download the app
One app. One membership.
100+ trusted global sources.