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Citi mentioned it has opened a 30-day catalyst look ahead to Ascendi Pharma (ASND) forward of anticipated FDA suggestions on the corporate’s resubmitted New Drug Software for its drug TransCon PTH within the remedy of hypoparathyroidism.
Citi mentioned it was a “purchaser” forward of the FDA suggestions, estimating the applying has an estimated 60% likelihood of being categorised as a Class 2 resubmission with a six-month overview interval. The financial institution mentioned it noticed 5% to twenty% upside from present ranges with that situation.
The financial institution estimated the likelihood of the applying being categorised as Class 1 resubmission with a two-month overview interval was round 30%, which would supply upside of 25% or extra.
It added that whereas the FDA might determine the NDA didn’t utterly handle the deficiencies outlined within the company’s Full Response Letter, it views that consequence as “unlikely.”
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