Brief: Abeona Therapeutics Announces Regulatory Update On Biologics License Application For EB-101

Abeona Therapeutics

09/06/2023 12:35

June 9 (Reuters) - Abeona Therapeutics Inc  ABEO.O :
    * ABEONA THERAPEUTICS ANNOUNCES REGULATORY UPDATE ON
BIOLOGICS
LICENSE APPLICATION (BLA) FOR EB-101
    * ABEONA: FDA REQUEST ADDITIONAL ASSAY DATA TO ESTABLISH
COMPARABILITY BETWEEN RVV SOURCED FROM INDIANA UNIVERSITY, RVV
MANUFACTURED IN-HOUSE AT ABEONA
    * ABEONA - TO ALLOW FDA NECESSARY TIME TO REVIEW REQUESTED
RVV
DATA, CO REQUESTED THAT ITS PRE-BLA MEETING DATE FOR EB-101 BE
RESCHEDULED FOR AUGUST
    * ABEONA THERAPEUTICS - EXPECTS TO FILE ITS BLA FOR EB-101
IN Q3
OF 2023

Source text for Eikon:  ID:nGNX26HdCQ 
Further company coverage:  ABEO.O 

 ((reuters.briefs@thomsonreuters.com;))