Shares of Ascendis Pharma (NASDAQ:ASND) cratered over 30% at the time of writing after disclosing that deficiencies were identified by the U.S. Food & Drug Administration (FDA) in the company’s new drug application (NDA) for TransCon PTH. The drug is for Hypoparathyroidism, a medical condition resulting in low levels of parathyroid hormone (PTH) in the body.
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Although Ascendis noted that the FDA’s communication does not represent its final decision on the NDA, it does mean that discussions regarding labeling and post-marketing requirements/commitments will not take place until the deficiencies in the NDA have been addressed.
However, Ascendis said that a decision from the European Commission regarding TransCon PTH remains on track for Q4 2023, which would allow it to launch the drug in its first European country in early 2024 if approved.
A look at the past five days shows the impact that today’s news had on ASND stock. Shares have essentially fallen off a cliff, causing investors to lose over 33% during this timeframe.
