Brief: REGENXBIO Announces Successful Pre-BLA Meeting with FDA to Support Accelerated Approval Pathway for RGX-121 for the Treatment of MPS II

Regenxbio

18/06/2024 12:20

June 18 (Reuters) - Regenxbio Inc  RGNX.O :
    * REGENXBIO ANNOUNCES SUCCESSFUL PRE-BLA MEETING WITH FDA TO
SUPPORT ACCELERATED APPROVAL PATHWAY FOR RGX-121 FOR THE
TREATMENT OF MPS II
    * REGENXBIO INC: CONFIRMATORY TRIAL EXPECTED TO BEGIN IN H2
2025
    * REGENXBIO INC: EXPECTS TO INITIATE SUBMISSION OF A ROLLING
BLA
IN Q3 OF 2024
    * REGENXBIO INC: A CONFIRMATORY STUDY OF RGX-121 IS EXPECTED
TO
INITIATE ENROLLMENT IN SECOND HALF OF 2025

Source text for Eikon:  ID:nPn9Fqp6ma 
Further company coverage:  RGNX.O 

 ((Reuters.Briefs@thomsonreuters.com;))