Brief: GenSight Biologics Granted Six-Month Extension In LUMEVOQ European Regulatory Review

Gensight Biologics SA

14/04/2022 06:46

April 14 (Reuters) - GENSIGHT BIOLOGICS SA  SIGHT.PA :
    * GENSIGHT BIOLOGICS GRANTED SIX-MONTH EXTENSION IN LUMEVOQ®
EUROPEAN REGULATORY REVIEW
    * NEW SUBMISSION DATE FOR DAY 120 RESPONSES: OCTOBER 2022
    * RESTART OF VALIDATION BATCHES IN Q3 2022
    * COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP)
OPINION
EXPECTED BY Q3 2023
    * ANNOUNCED THAT COMMITTEE FOR ADVANCED THERAPIES (CAT) OF
EUROPEAN MEDICINES AGENCY (EMA) HAS GRANTED COMPANY A SIX-MONTH
EXTENSION FOR SUBMITTING ITS RESPONSES TO DAY 120 QUESTIONS IN
REGULATORY REVIEW OF LUMEVOQ®, GENSIGHT'S GENE THERAPY FOR
TREATMENT OF LEBER HEREDITARY OPTIC NEUROPATHY (LHON).

Source text for Eikon:  urn:newsml:reuters.com:*:nBw94rm2Va
Further company coverage:  SIGHT.PA 

 (Gdansk Newsroom)
 ((Gdansk.newsroom@thomsonreuters.com; +48 58 772 09 20;))