Brief: XSpray: Positive Preliminary Results From HyNap-Dasa Study

Xspray Pharma publ AB

25/09/2020 08:57

Sept 25 (Reuters) - XSpray Pharma AB (publ)  XSPRAY.ST :
    * XSPRAY ANNOUNCES POSITIVE PRELIMINARY RESULTS FROM THE
STUDY FOR
ITS LEAD PRODUCT CANDIDATE HYNAP-DASA
    * RESULT SHOWS THAT BIOEQUIVALENCE BETWEEN HYNAP-DASA AND
SPRYCEL
WAS ACHIEVED
    * STUDY FULFILLED STATISTICAL AND FORMAL BIOEQUIVALENCE
REQUIREMENTS FOR HYNAP-DASA COMPARED TO THE REFERENCE PRODUCT
SPRYCEL
    * WILL EXPLORE IF TOTALITY OF DATA FROM TWO STUDIES WILL
SUFFICE
FOR SUBMITTAL OF ANDA-APPLICATION, WHICH WILL THEN BE DONE
DURING Q4
    * IN CASE THAT ADDITIONAL STUDY IS NEEDED, ANDA-APPLICATION
WOULD
BE SUBMITTED DURING Q1 2021

Source text: https://bit.ly/3kSfq7v
Further company coverage:  XSPRAY.ST 

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