Ascendis Pharma Extends FDA Review Period for TransCon™ PTH

Ascendis Pharma, Inc. (Nasdaq: ASND) has received notification from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for TransCon PTH (palopegteriparatide) aimed at treating adults with hypoparathyroidism. The FDA has informed Ascendis Pharma that the additional information provided during the review process necessitates a more extensive evaluation, classifying it as a major amendment. Consequently, the Prescription Drug User Fee Act (PDUFA) goal date for the review has been extended by three months to August 14, 2024.

Jan Mikkelsen, President and Chief Executive Officer of Ascendis Pharma, emphasized the company's responsiveness to the FDA's requests and its ongoing collaboration with the agency during this extended review period. Mikkelsen also assured that adults in the United States who are currently participating in clinical trials or are enrolled in the Expanded Access Program (EAP) for TransCon PTH will continue to have access to their medication. The EAP remains open for new eligible patients, reflecting Ascendis Pharma's commitment to addressing the unmet medical needs of those with hypoparathyroidism.

Ascendis Pharma specializes in its innovative TransCon technology platform, striving to establish itself as a leading biopharmaceutical company dedicated to significantly improving patient outcomes. With its headquarters in Copenhagen, Denmark, and additional facilities across Europe and the United States, Ascendis Pharma leverages its TransCon technologies to develop new, potentially superior therapies. The company's guiding principles are centered on patients, science, and passion, driving its mission to make a meaningful difference in the lives of patients.