Brief: Poxel Announces Positive Update Following FDA Meeting For PXL065 For Treatment Of NASH

Poxel SA

08/11/2019 07:14

Nov 8 (Reuters) - Poxel SA  POXEL.PA :
    * POXEL ANNOUNCES POSITIVE UPDATE FOLLOWING FDA MEETING FOR
PXL065
FOR TREATMENT OF NASH
    * POXEL PROVIDES UPDATE ON PXL065 PHASE 2 TRIAL DESIGNED TO
IDENTIFY OPTIMAL DOSE OR DOSES FOR PHASE 3 REGISTRATION TRIAL;
INITIATION IS EXPECTED IN Q2 2020
    * FDA FEEDBACK SUPPORTS PLAN TO ADVANCE PXL065 USING 505
REGULATORY PATHWAY FOR NASH
    * IN SEPTEMBER 2019, PHASE 1B MULTIPLE ASCENDING DOSE (MAD)
TRIAL
HAS BEEN INITIATED
    * RESULTS OF THIS STUDY ARE EXPECTED IN Q4 2019.
    * PLANS TO SUBMIT A FAST TRACK DESIGNATION REQUEST FOR
PXL065

Source text for Eikon:  ID:nBw5hMXj2a 
Further company coverage:  POXEL.PA 

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