Brief: SOBI, Apellis Announce Positive Topline Results From VALIANT Study

Swedish Orphan Biovitrum AB (publ)

08/08/2024 12:30

Aug 8 (Reuters) - Swedish Orphan Biovitrum AB (publ)  SOBIV.ST :
    * SOBI AND APELLIS ANNOUNCE POSITIVE TOPLINE RESULTS FROM PHASE 3 VALIANT STUDY OF
PEGCETACOPLAN
IN C3G AND PRIMARY IC-MPGN
    * MET PRIMARY ENDPOINT, ACHIEVING STATISTICALLY SIGNIFICANT 68% (P<0.0001) REDUCTION IN
PROTEINURIA COMPARED TO PLACEBO IN A BROAD STUDY POPULATION
    * PLANS TO SUBMIT A MARKETING APPLICATION WITH EUROPEAN MEDICINES AGENCY (EMA) IN 2025
    * APELLIS ALSO PLANS TO SUBMIT A SUPPLEMENTAL NEW DRUG APPLICATION TO U.S. FOOD AND DRUG
ADMINISTRATION (FDA) IN EARLY 2025

Source text for Eikon:  ID:nWkr96GNPP 
Further company coverage:  SOBIV.ST 

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