The US Food and Drug Administration (FDA) did not grant its approval to Ascendis Pharma’s experimental hormone disorder therapy, but the company’s stock has soared Monday nonetheless.
The therapy, called TransCon OTH, is designed to treat adult patients with a disorder called hypoparathyroidism, in which the body produces abnormally low levels of parathyroid hormone. This can cause tingling or burning in the fingertips, toes and lips; muscle spasms and other symptoms.
The good news for Ascendis is that the FDA’s reason for denying approval was due to concerns about manufacturing control of the drug and device combination — as opposed to concerns about the clinical data the company submitted.
The FDA did not ask for new data, and Ascendis said it would request a meeting with the agency as soon as possible.
Shares of the Danish company jumped nearly 23% to $86.
However, the stock still remains well below its price early last month, when it fell more than 32% from $107.22 after the FDA said it identified unspecified deficiencies in the company's application.
Contact Andrew Kessel at andrew.kessel@proactiveinvestors.com
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