On April 3, 2023, before market hours, Ascendis announced that the “U.S. Food & Drug Administration (“FDA”) has notified the Company that, as part of their ongoing review, the FDA has identified deficiencies in the Company’s New Drug Application (“NDA”) for TransCon PTH (palopegteriparatide) in hypoparathyroidism that at this time precludes them from holding further discussions about labeling and post-marketing requirements/commitments. The deficiencies were not disclosed in the letter.”
On this news, the price of Ascendis’ American Depository Shares (“ADSs”) fell as much as 34.71% in intraday trading to open at $67.12 on April 3, 2023.
