FDA official website and press releases

FDA Approves Ascendis Pharma's YORVIPATH, Stock Surges 11.8% Premarket

Aug 12, 2024, 11:53 AM

The U.S. Food and Drug Administration (FDA) has approved Ascendis Pharma's YORVIPATH® (Palopegteriparatide) as the first and only treatment for hypoparathyroidism in adults. This approval marks a significant milestone as it fills the gap left by Takeda's withdrawal of its treatment for the same condition. The announcement has led to a notable increase in Ascendis Pharma's stock, which surged over 11.8% in premarket trading. Hypoparathyroidism is a rare hormone disorder, and YORVIPATH® will now be the only approved treatment available in the U.S. for this condition.