January 23, 2018 / 7:47 AM / 10 months ago

BRIEF-Genfit: Official Launch Of NASH Pediatric Program In US

Jan 23 (Reuters) - GENFIT SA:

* REG-GENFIT: OFFICIAL LAUNCH OF THE NASH PEDIATRIC PROGRAM, FOLLOWING PIP AND PSP AGREEMENT BY EMA AND FDA

* ‍FDA AGREES WITH ELAFIBRANOR’S INITIAL PSP FOR LAUNCH OF NASH PEDIATRIC CLINICAL TRIAL IN US

* ‍PHASE 2B DATA SUPPORTIVE OF ELAFIBRANOR’S POTENTIAL BENEFIT IN NASH PEDIATRIC POPULATION​

* PSP AGREEMENT BY FDA CONSISTENT WITH PIP (PEDIATRIC INVESTIGATION PLAN) AGREEMENT BY EMA (EUROPEAN MEDICINES AGENCY)

* ‍DOSE RANGING STUDY TO START IN COMING WEEKS, ON YOUNG NASH PATIENTS LIVING IN US (8-17 YEARS OLD)​ Source text for Eikon: Further company coverage: (Gdynia Newsroom)

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