Brief: Gensight Biologics To Submit LUMEVOQ For European Approval In September 2020

Gensight Biologics SA

15/04/2020 06:37

April 15 (Reuters) - GENSIGHT BIOLOGICS SA  SIGHT.PA :
    * GENSIGHT BIOLOGICS ON TRACK TO SUBMIT LUMEVOQ® FOR
EUROPEAN
APPROVAL IN SEPTEMBER 2020 FOLLOWING PRE-SUBMISSION MEETING WITH
EMA
    * BASED ON ITS SUCCESSFUL CONCLUSION, GENSIGHT BIOLOGICS
CONFIRMS
ITS INTENTION TO SUBMIT MAA FOR LUMEVOQ(®) IN SEPTEMBER 2020
    * AS A FINAL STEP BEFORE ACTUAL SUBMISSION, AND AS PART OF
EMA’S
PROCEDURES, GENSIGHT BIOLOGICS EXPECTS TO RE-CONFIRM BY JULY ITS
INTENT TO SUBMIT IN SEPTEMBER

Source text for Eikon:  ID:nBw106H33a 
Further company coverage:  SIGHT.PA 

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