Brief: PepGen Inc. Announces Clinical Hold In U.S. on IND Application to Initiate a Phase 1 Study of PGN-EDODM1

PepGen

30/05/2023 21:08

May 30 (Reuters) - PepGen Inc  PEPG.O :
    * PEPGEN INC. ANNOUNCES CLINICAL HOLD IN THE U.S. ON IND
APPLICATION TO INITIATE A PHASE 1 STUDY OF PGN-EDODM1 FOR
MYOTONIC DYSTROPHY TYPE 1 (DM1)
    * PEPGEN INC - FDA INDICATED ITS INTENTION TO PROVIDE AN
OFFICIAL
CLINICAL HOLD LETTER TO PEPGEN STATING REASONS FOR CLINICAL HOLD
WITHIN 30 DAYS
    * PEPGEN INC - DISAPPOINTED TO RECEIVE A CLINICAL HOLD
NOTICE ON
OUR PLANNED PGN-EDODM1 STUDY IN U.S
    * PEPGEN INC - WILL WORK CLOSELY WITH FDA TO LIFT HOLD AS
QUICKLY
AS POSSIBLE
    * PEPGEN INC - IN PARALLEL, CONTINUE TO PURSUE ADVANCEMENT
OF
PGN-EDODM1 INTO CLINIC OUTSIDE U.S
    * PEPGEN INC - REMAIN WELL-CAPITALIZED TO FUND CONTINUED
DEVELOPMENT OF BOTH EDO51 AND EDODM1

Source text for Eikon:  ID:nGNX9MZW2D 
Further company coverage:  PEPG.O 

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