ZSAN - Zosano shares rise on migraine treatment NDA resubmission update

Zosano Pharma (ZSAN) shares climb more than 9% premarket after the company announces that it has received feedback from the U.S. FDA on the protocol for the pharmacokinetic (“PK”) study required to support the resubmission of its migraine treatment Qtrypta's New Drug Application.The company expects the study to begin in June and to be completed with data available in the third quarter of 2021.Subject to positive data, Zosano expects to resubmit its NDA for Qtrypta by the end of 2021.Zosano has established an agreement with Worldwide Clinical Trials to conduct the study, which is expected to involve 48 healthy volunteers to generate comparative pharmacokinetic and safety data. The company had received a complete response letter for the initial NDA citing inconsistent zolmitriptan exposure levels observed across clinical pharmacology studies, in October last year.

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Zosano shares rise on migraine treatment NDA resubmission update