Ascendis Pharma announced on Monday that its therapy for a hormone disorder has received approval from the U.S. Food and Drug Administration (FDA), causing the Danish drugmaker’s shares to surge by over 10% in premarket trading.
The therapy, known as Yorvipath, will be the sole approved treatment for hypoparathyroidism in the United States following Takeda’s decision to discontinue its Natpara injection by the end of this year due to supply challenges.
The FDA’s approval of Yorvipath follows previous hurdles, including a review extension in May and a prior rejection due to concerns about the drug’s manufacturing controls and its combination with a delivery device.
Clinical trials demonstrated that most patients using Yorvipath did not need to rely on daily vitamin D and calcium supplements, which are the current standard treatments for hypoparathyroidism.
Hypoparathyroidism is a rare endocrine disorder characterized by insufficient levels of parathyroid hormone, leading to low blood calcium levels and elevated phosphorus. The condition affects an estimated 70,000 to 90,000 people in the U.S., according to Ascendis.
The company expects to have the once-daily therapy available by the first quarter of 2025 and plans to reveal its annual price in the coming week.
Evercore ISI analyst Gavin Clark-Gartner projects peak sales for Yorvipath to reach approximately $2.5 billion, with a market penetration of around 12.5% in the U.S.
Ascendis Pharma also plans to seek FDA approval to market its existing products in other regions within the U.S., potentially introducing these in the fourth quarter of 2024 if approved.
