Brief: Graphite Bio Announces Voluntary Pause Of Phase 1/2 Cedar Study Of Nulabeglogene Autogedtemcel (Nula-Cel) For Sickle Cell Disease

LENZ Therapeutics

05/01/2023 21:54

Jan 5 (Reuters) - Graphite Bio Inc  GRPH.O :
    * GRAPHITE BIO ANNOUNCES VOLUNTARY PAUSE OF PHASE 1/2 CEDAR
STUDY
OF NULABEGLOGENE AUTOGEDTEMCEL (NULA-CEL) FOR SICKLE CELL
DISEASE
    * GRAPHITE BIO INC-ANNOUNCED VOLUNTARILY PAUSING DUE TO
SERIOUS
ADVERSE EVENT IN FIRST PATIENT DOSED WITH NULA-CEL
    * GRAPHITE BIO INC - WILL NOT MEET ITS GUIDANCE FOR INITIAL
PROOF-OF-CONCEPT DATA IN MID-2023
    * GRAPHITE BIO INC - EVENT HAS BEEN REPORTED TO U.S. FOOD
AND DRUG
ADMINISTRATION
    * GRAPHITE BIO INC - EVENT DID NOT MEET STUDY STOPPING
REQUIREMENTS, BASED ON EVOLVING CLINICAL DATA, CO DECIDED TO
VOLUNTARILY PAUSE STUDY
    * GRAPHITE BIO INC-COMPREHENSIVELY ASSESSING ADVERSE EVENT,
RISK
FACTORS, MITIGATION STRATEGIES, INCLUDING POTENTIAL
MODIFICATIONS TO NULA-CEL MANUFACTURING PROCESS
    * GRAPHITE BIO INC - NO LONGER EXPECTS TO FILE AN
INVESTIGATIONAL
NEW DRUG APPLICATION FOR GPH102 IN BETA-THALASSEMIA BY MID-2024
    * GRAPHITE BIO INC - WORKING TO IDENTIFY OPERATIONAL
EFFICIENCIES
TO EXTEND ITS CASH POSITION TO AT LEAST 2026

Source text for Eikon:  ID:nBw4lgHNra 
Further company coverage:  GRPH.O 
 ((Reuters.Briefs@thomsonreuters.com;;))