Brief: PepGen Inc. Announces FDA Has Lifted The Clinical Hold On Its Investigational New Drug Application

PepGen

12/10/2023 12:07

Oct 12 (Reuters) - PepGen Inc  PEPG.O :
    * PEPGEN INC. ANNOUNCES FDA HAS LIFTED THE CLINICAL HOLD ON
ITS
INVESTIGATIONAL NEW DRUG APPLICATION FOR FREEDOM-DM1 PHASE 1
STUDY OF PGN-EDODM1 FOR MYOTONIC DYSTROPHY TYPE 1 (DM1)
    * PEPGEN INC: LIFTING OF FDA HOLD ALLOWS FREEDOM-DM1 STUDY
TO
LAUNCH IN U.S. WITH TARGET DOSE LEVELS OF 5 MG/KG, 10 MG/KG AND
20 MG/KG
    * PEPGEN INC. ANNOUNCES FDA HAS LIFTED THE CLINICAL HOLD ON
ITS
INVESTIGATIONAL NEW DRUG APPLICATION FOR FREEDOM-DM1 PHASE 1
STUDY OF PGN-EDODM1 FOR MYOTONIC DYSTROPHY TYPE 1 (DM1)
    * PEPGEN INC: SAFETY, TRANSCRIPT SPLICING AND CLINICAL
OUTCOME
MEASURES DATA AT 5 MG/KG PGN-EDODM1 DOSE LEVEL IN PATIENTS FROM
FREEDOM-DM1 CLINICAL STUDY EXPECTED IN 2024
    * PEPGEN INC - CASH RUNWAY EXPECTED TO FUND OPERATIONS INTO
2025
    * PEPGEN INC: CASH RUNWAY EXPECTED TO FUND OPERATIONS INTO
2025

Source text for Eikon:  ID:nGNX2bVjrx 
Further company coverage:  PEPG.O 

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