Grandbrothers/iStock Editorial via Getty Images Shares of Ascendis Pharma ( ASND ) jumped over 10% premarket on Monday after the FDA approved Yorvipath (palopegteriparatide; developed as TransCon PTH) for the treatment of hypoparathyroidism in adults. With this approval, Yorvipath becomes the first and only treatment for hypoparathyroidism in adults. Administered once daily, Yorvipath is a prodrug of parathyroid hormone (PTH), designed to provide continuous exposure to released PTH over the 24-hour dosing period.
The FDA based its approval on their review of the clinical package for TransCon PTH (palopegteriparatide) submitted with the company’s new drug application, including data from the global Phase 2 PaTH Forward and Phase 3 PaTHway trials. The Danish pharma is completing manufacturing of commercial product for the U.S.
market and anticipates initial supply will be available in the first quarter of 2025. In addition, Ascendis plans to request FDA approval to commercialize its existing manufactured product, which, if approved, could be introduced in the U.S.
in the fourth quarter of 2024. More on Ascendis Pharma Weaker USD, Revenue Growth, And TransCon Technology Make Ascendis Pharma A Strong Buy Opportunity Ascendis Pharma says FDA has delayed TransCon PTH review Seeking Alpha’s Quant Rating on Ascendis Pharma Historical earnings data for Ascendis Pharma Financial information for Ascendis Pharma.
