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Precigen Reports Third Quarter 2024 Financial Results and Business Updates
PrecigenPrecigen(US:PGEN) Prnewswire·2024-11-14 21:30

–   Completed pre-BLA meeting with FDA with full alignment on content of BLA, including CMC module, and path for fourth quarter 2024 rolling BLA submission for PRGN-2012† in RRP under accelerated approval pathway ––   Commercial and manufacturing readiness campaign underway for PRGN-2012 in anticipation of a potential 2025 launch ––   Confirmatory clinical trial for PRGN-2012 in RRP was initiated in accordance with guidance from FDA to initiate prior to submission of the BLA; continuing enrollment ––   Prep ...