Brief: Precigen Says Got FDA Confirmation For Phase 1/2 Study Of PRGN-2012 Adenoverse Immunotherapy

Precigen

09/08/2023 12:09

Aug 9 (Reuters) - Precigen Inc  PGEN.O :
    * PRECIGEN ANNOUNCES FDA CONFIRMATION THAT THE ONGOING PHASE
1/2
STUDY OF PRGN-2012 ADENOVERSE IMMUNOTHERAPY WILL SERVE AS THE
PIVOTAL STUDY TO SUPPORT ACCELERATED APPROVAL
    * PRECIGEN INC - BASED ON FDA GUIDANCE, COMPANY PLANS TO
INITIATE
A CONFIRMATORY STUDY PRIOR TO SUBMISSION OF BLA
    * PRECIGEN INC - PATIENT FOLLOW UP IS CURRENTLY ONGOING AND
DATA
COLLECTION IS ANTICIPATED TO BE COMPLETED BY Q2 OF 2024

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