Brief: Inovio Receives FDA Feedback That Data From Completed Phase 1/2 Trial Of INO-3107 Can Be Used To Submit A BLA Under Accelerated Approval Program

Inovio Pharmaceuticals

10/10/2023 13:43

Oct 10 (Reuters) - Inovio Pharmaceuticals Inc  INO.O :
    * INOVIO RECEIVES FDA FEEDBACK THAT DATA FROM COMPLETED
PHASE 1/2
TRIAL OF INO-3107 CAN BE USED TO SUBMIT A BLA UNDER ACCELERATED
APPROVAL PROGRAM
    * INOVIO PHARMACEUTICALS INC - INO-3107 COULD BE FIRST DNA
MEDICINE AVAILABLE IN UNITED STATES AND FIRST COMMERCIAL PRODUCT
FOR INOVIO
    * INOVIO PHARMACEUTICALS INC: PREVIOUSLY PLANNED PHASE 3
TRIAL NO
LONGER REQUIRED TO SUPPORT BIOLOGICAL LICENSE APPLICATION
SUBMISSION
    * INOVIO PHARMACEUTICALS INC - NOW FOCUSED ON STREAMLINING
OUR
DEVELOPMENT PLAN TO SUPPORT SUBMISSION OF A BLA FOR ACCELERATED
APPROVAL
    * INOVIO PHARMACEUTICALS INC: CHANGES TO DEVELOPMENT PLAN
FOR
INO-3107 AS A RESULT OF FDA FEEDBACK ANNOUNCED COULD AFFECT
PRIOR CASH GUIDANCE

Source text for Eikon:  ID:nPn2vPjbpa 
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 ((Reuters.Briefs@thomsonreuters.com))