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Precigen to Present Late-breaking Abstract for Pivotal Phase 2 Study Data for PRGN-2012 AdenoVerse Immunotherapy for the Treatment of Patients with Recurrent Respiratory Papillomatosis at the 2024 ASC streetinsider.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from streetinsider.com Daily Mail and Mail on Sunday newspapers.
– Based on FDA confirmation in August 2023 that the ongoing Phase 1/2 single-arm study of PRGN-2012 in RRP will serve as the pivotal study to support BLA. ....
– 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. ....
Precigen Inc. (PGEN) Granted FDA Breakthrough Therapy Designation for PRGN-2012 streetinsider.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from streetinsider.com Daily Mail and Mail on Sunday newspapers.
– First FDA Breakthrough Therapy Designation granted for AdenoVerse immunotherapy platform; designation prioritizes PRGN-2012 as a potential treatment for RRP –– . | June 20, 2023 ....