Ascendis Pharma to initiate TransCon PTH U.S. expanded access program

Ascendis Pharma announced that the U.S. Food & Drug Administration, FDA, has allowed the Company to initiate an expanded access program for its investigational parathyroid hormone replacement therapy, TransCon PTH, for adult patients with hypoparathyroidism. To qualify, patients must live in the U.S., have PTH treatment experience, and have medical needs that cannot be addressed by commercial products or clinical trials. TransCon PTH is an investigational prodrug in development for adult patients with hypoparathyroidism. The safety and efficacy of TransCon PTH have not been established and TransCon PTH is not currently approved by the FDA. It is currently under Priority Review by the FDA, with a Prescription Drug User Fee Act target action date of April 30, 2023.