Bengaluru: Denmark-based Ascendis Pharma A/S said on Monday the US Food & Drug Administration had declined to approve its experimental therapy to treat adult patients with a hormone disorder called hypoparathyroidism, citing concerns related to manufacturing control of the drug and device combination. The agency, however, did not express concerns about the clinical data submitted and did not seek fresh pre-clinical or late-stage trials in a so-called complete response letter, the company said.
Ascendis’ US-listed shares rose 12 per cent in premarket trade. The FDA, early last month, had identified unspecified deficiencies in the company’s application for approval of the therapy, TransCon PTH.
TD Cowen analyst Yaron Werber had raised concerns about the lack of clarity around FDA‘s decision in a note on Friday.
He said a complete response letter declining approval was likely, adding the stock will slump if the FDA sought another pre-clinical or clinical study as this would delay approval by 1.5-2 years.
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