Brief: Oncopeptides Updates On Type II Application Process

Oncopeptides AB

18/12/2023 08:02

Dec 18 (Reuters) - Oncopeptides AB  ONCO.ST :
    * UPDATED ON FRIDAY ON THE TYPE II APPLICATION PROCESS
    * SAID EUROPEAN COMMISSION HAS DECIDED TO FORMALLY APPROVE
APPLICATION TO THE EUROPEAN MEDICINES AGENCY (EMA) FOR AN
EXTENDED INDICATION FOR PEPAXTI INTO EARLIER LINES
    * PREVIOUSLY COMMUNICATED DECISION BY ONCOPEPTIDES TO OPT
OUT OF
THE PROCESS TO EXTEND THE INDICATION REMAINS
    * HAS SUBMITTED AN APPLICATION TO ADJUST THE INDICATION OF
PEPAXTI
TO THE ORIGINALLY APPROVED INDICATION, A PROCESS THAT IS
EXPECTED TO BE FINALIZED IN EARLY 2024    


        
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