Precigen Completes Submission of BLA with Request for Priority Review to the FDA for PRGN-2012 for the Treatment of Adults with Recurrent Respiratory Papillomatosis

Core Insights - PRGN-2012 has the potential to be the first FDA-approved therapeutic for adults with recurrent respiratory papillomatosis (RRP), a rare and chronic disease requiring repeated surgeries as the current standard of care [1][9] - The biologics license application (BLA) for PRGN-2012 has been submitted to the FDA and is currently under a 60-day review period, with a request for priority review to expedite the process [8][15] - The BLA is supported by a pivotal Phase 1/2 clinical study showing that over 50% of patients achieved a Complete Response and more than 85% had a decrease in surgical interventions post-treatment [1][3] Company Overview - Precigen, Inc. is a biopharmaceutical company focused on developing innovative gene and cell therapies targeting urgent diseases in immuno-oncology, autoimmune disorders, and infectious diseases [5] - The company utilizes its proprietary AdenoVerse platform for efficient gene delivery, aiming to generate durable immune responses against diseases caused by human papillomavirus (HPV) [4][2] - Precigen's financial position has been strengthened to support the potential commercial launch of PRGN-2012 in the second half of 2025, extending its cash runway into 2026 [15]