Why Ascendis Pharma Stock Is Plunging Today
Shares of the mid-cap biopharma Ascendis Pharma A/S (NASDAQ: ASND) are under heavy pressure today. Specifically, the drugmaker's stock was done by a hefty 34% as of 11:24 a.m. ET Monday morning.
What went wrong? Ahead of the opening bell, Ascendis announced that the Food and Drug Administration (FDA) has identified deficiencies in its New Drug Application (NDA) for the hypoparathyroidism candidate TransCon PTH (palopegteriparatide) that prevent the agency from holding further discussions about labeling and post-marketing requirements/commitments. Ascendis' management further noted that the specific deficiencies were not disclosed in the letter and that this notification does not reflect the FDA's final regulatory decision regarding TransCon PTH's NDA.
What's the big deal? With a wide-open field, Wall Street analysts had sky-high expectations for TransCon PTH's commercial prospects as a treatment for hypoparathyroidism. In fact, the drug was forecast to haul in more than $1 billion in annual sales by mid-2025, according to multiple analysts.
Source Fool.com
