Brief: Orchard Therapeutics Says Still Preparing For Potential Approval For OTL-200 In 2020

Orchard Therapeutics

31/03/2020 22:07

March 31 (Reuters) - Orchard Therapeutics PLC  ORTX.O :
    * ORCHARD THERAPEUTICS OUTLINES BUSINESS IMPACT OF COVID-19
    * ORCHARD THERAPEUTICS - COVID-19 PANDEMIC HAS & MAY
CONTINUE TO
IMPACT CO'S DEVELOPMENT PROGRAMS TIMELINES, PRODUCT SUPPLY,
COMMERCIAL OPERATIONS, FINANCIAL POSITION
    * ORCHARD THERAPEUTICS - STILL PREPARING FOR POTENTIAL
APPROVAL
FOR OTL-200 IN 2020
    * ORCHARD THERAPEUTICS - OTL-200 TIMELINE COULD BE EXTENDED
AS
RESULT OF COORDINATION NEEDED AMONG EMA, CO, OTHER KEY
STAKEHOLDERS INVOLVED IN REVIEW PROCESS
    * ORCHARD THERAPEUTICS - NOW BELIEVES IT IS LIKELY TO SUBMIT
BIOLOGICS LICENSE APPLICATION FOR MLD WITH U.S. FDA IN H1  2021
DUE TO COVID-19 RELATED IMPACTS
    * ORCHARD THERAPEUTICS - DOES NOT EXPECT TO COMPLETE
NECESSARY
ACTIVITIES TO ENABLE INITIATION OF ROLLING BLA FOR OTL-101 IN
U.S. IN H1 2020
    * ORCHARD THERAPEUTICS PLC - U.S. AND EU REGULATORY FILINGS
FOR
OTL-103 PROGRAM IN WAS REMAIN ON TRACK FOR 2021
    * ORCHARD THERAPEUTICS - BELIEVES IT HAS ENROLLED, TREATED
ENOUGH
PATIENTS TO SUPPORT REGULATORY FILINGS FOR OTL-200 IN U.S. &
EUROPE
    * ORCHARD THERAPEUTICS - COVID-19-RELATED IMPACTS ARE LIKELY
TO
SHIFT ENROLLMENT TIMELINES OF OTL-201 AND OTL-103 TRIALS BY AT
LEAST THREE MONTHS
    * ORCHARD THERAPEUTICS PLC - KEY SUPPLIERS HAVE REMAINED
OPERATIONAL FOR CERTAIN CRITICAL ACTIVITIES DESPITE COVID-19
SITUATION
    * ORCHARD THERAPEUTICS - CONSTRUCTION ACTIVITIES ON CO'S
PLANNED
MANUFACTURING FACILITY IN FREMONT, CALIFORNIA, HAVE BEEN
TEMPORARILY SUSPENDED AS A RESULT OF COVID-19 PANDEMIC

Source text for Eikon:  ID:nGNX2ZBX1y 
Further company coverage:  ORTX.O 

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