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

–   fda confirmed that the ongoing phase 1/2 single arm study will serve as pivotal and no additional randomized, placebo-controlled trial will be required to support submission of a bla  –  –   fda agreed on the required efficacy and safety endpoints that will support filing an accelerated approval bla for licensure – –   e nrollment and dosing in the ongoing phase 2 portion of the study is completed – –   if approved, prgn-2012 would potentially be the first therapeutic for the treatment of rrp, a serious and difficult-to-treat orphan indication for which the current standard-of-care is repeated surgeries   – germantown, md. , aug. 9, 2023 /prnewswire/ -- precigen, inc. (nasdaq: pgen), a biopharmaceutical company specializing in the development of innovative gene and cell therapies to improve the lives of patients, today announced that the us food and drug administration (fda) has agreed that the ongoing phase 1/2 single arm study (nct04724980) of the first-in-class investigational prgn-2012 adenoverse™ immunotherapy for the treatment of recurrent respiratory papillomatosis (rrp) will serve as pivotal for the purpose of filing an accelerated approval request for licensure.
PGEN Ratings Summary
PGEN Quant Ranking