Edition:
India

Allena Pharmaceuticals Initiates First Phase 3 Trial For ALLN-177 In Patients With Enteric Hyperoxaluria


Tuesday, 6 Mar 2018 

March 6 (Reuters) - Allena Pharmaceuticals Inc ::ALLENA PHARMACEUTICALS INITIATES FIRST PHASE 3 TRIAL FOR ALLN-177 IN PATIENTS WITH ENTERIC HYPEROXALURIA.ALLENA PHARMACEUTICALS INC - ‍TOPLINE DATA FROM PHASE 3 TRIAL FOR ALLN-177 EXPECTED IN SECOND HALF OF 2019​.ALLENA PHARMACEUTICALS INC - ‍EXPECTS TO INITIATE URIROX-2 IN SECOND HALF OF 2018, CONSISTENT WITH PRIOR GUIDANCE​.ALLENA - ‍INITIATION OF URIROX-1 TRIAL FOLLOWS MULTIPLE INTERACTIONS WITH FDA AFTER WHICH FDA CONFIRMED IT HAD NO COMMENTS ON PROTOCOL​.ALLENA PHARMACEUTICALS INC - ‍CONTINUES TO ENGAGE WITH FDA TO FINALIZE DESIGN OF URIROX-2​.ALLENA - ENGAGING FDA TO DISCUSS PURSUING ACCELERATED APPROVAL PATHWAY FOR PLANNED BLA SUBMISSION FOR ALLN-177 IN PATIENTS WITH ENTERIC HYPEROXALURIA​.ALLENA - ‍BELIEVES PHASE 3 PROGRAM, IF SUCCESSFUL, COULD BE ELIGIBLE FOR MAA VIA CONDITIONAL APPROVAL PATHWAY​. 

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