Brief: UroGen Announces FDA Acceptance of Investigational New Drug Application for UGN-103

UroGen Pharma

15/04/2024 13:22

April 15 (Reuters) - Urogen Pharma Ltd  UR8.F :
    * UROGEN ANNOUNCES FDA ACCEPTANCE OF INVESTIGATIONAL NEW
DRUG
APPLICATION FOR UGN-103, A NEXT GENERATION MITOMYCIN-BASED
FORMULATION FOR LOW-GRADE INTERMEDIATE-RISK NON-MUSCLE INVASIVE
BLADDER CANCER
    * UROGEN PHARMA LTD: PLANS TO INITIATE A PHASE 3 STUDY TO
EXPLORE
SAFETY AND EFFICACY OF UGN-103 IN 2024
    * UROGEN PHARMA LTD - UROGEN INTENDS TO COMPLETE ROLLING NEW
DRUG
APPLICATION (NDA) SUBMISSION FOR UGN-102 IN SEPTEMBER 2024
    * UROGEN PHARMA LTD - FOR UGN-102 POTENTIAL FDA DECISION AS
EARLY
AS Q1 OF 2025 IF PRIORITY REVIEW IS GRANTED BY FDA

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