Brief: Gensight Expects To Start LUMEVOQ PPQ Campaign In May

Gensight Biologics SA

07/03/2023 06:43

March 7 (Reuters) - Gensight Biologics SA  SIGHT.PA :
    * GENSIGHT BIOLOGICS PROVIDES UPDATE ON LUMEVOQ
MANUFACTURING AND
COMMERCIALIZATION TIMELINES
    * PPQ CAMPAIGN TO START EARLY MAY 2023 (PREVIOUSLY END OF
MARCH)
WITH RESULTS EXPECTED IN Q3 2023
    * EMA CHMP OPINION NOW EXPECTED IN Q1 2024 (PREVIOUSLY
SEPTEMBER
2023)
    * DUE TO OCCURRENCE OF AN OPERATIONAL ISSUE AT TFS IN
HANDLING OF
DOWNSTREAM PROCESS, BATCH HAS BEEN TERMINATED
    * PRECISE ROOT CAUSE IS BEING INVESTIGATED IN COLLABORATION
WITH
TFS BEFORE INITIATING VALIDATION CAMPAIGN
    * TO PREVENT REOCCURRENCE OF SUCH AN OPERATIONAL ISSUE AND
SECURE
A SUCCESSFUL OUTCOME, GENSIGHT AGREED WITH TFS TO JOINTLY
INVOLVE MSAT TEAM AND GENSIGHT'S OWN EXPERTS REAL TIME IN
CONDUCT OF VALIDATION CAMPAIGN

Source text for Eikon:  ID:nBw7kHKwWa 
Further company coverage:  SIGHT.PA 

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