Ascendis Pharma Receives Orphan Drug Exclusivity in the US for YORVIPATH (Palopegteriparatide) for the Treatment of Hypoparathyroidism in Adults Page 1

– The U.S. FDA Orphan Drug Exclusivity Grants YORVIPATH Seven Years of Market Exclusivity in the United States for the Treatment of Hypoparathyroidism in Adults

COPENHAGEN, Denmark, Sept. 11, 2024 (GLOBE NEWSWIRE) — Ascendis Pharma A/S (Nasdaq: ASND) today announced that the U.S. Food & Drug Administration (FDA) has granted orphan drug exclusivity to YORVIPATH (palopegteriparatide, developed as TransCon PTH), granting YORVIPATH seven years of market exclusivity in the United States for the treatment of hypoparathyroidism in adults. YORVIPATH is a once-daily prodrug of parathyroid hormone (PTH (1-34)), designed to provide continuous exposure to released PTH over the 24-hour dosing period. Hypoparathyroidism is a rare endocrine disease caused by insufficient levels of parathyroid hormone affecting multiple organs and is estimated to affect 70,000 to 90,000 people in the United States.