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www.precigen.comPrecigen and the Recurrent Respiratory Papillomatosis Foundation will host the 2025 International RRP Awareness Day on June 11, focusing on patient experiences and community support for recurrent respiratory papillomatosis (RRP). The event aims to foster dialogue among patients, caregivers, and healthcare professionals about the challenges of living with this rare disease.
otherPrecigen, Inc. will co-host the annual RRP Awareness Day on June 11, 2025, in Washington DC, focusing on raising awareness for recurrent respiratory papillomatosis and the need for new treatment options.
conference talkPrecigen's Phase 1/1b clinical trial of PRGN-3006, an investigational adoptive cellular therapy targeting CD33-positive relapsed or refractory acute myeloid leukemia (AML), measurable residual disease (MRD)-positive AML, and higher-risk myelodysplastic syndromes (MDS), is expected to complete on August 1, 2025. The study, which has finished dose escalation and is in the dose expansion phase, is assessing safety and tolerability in 88 enrolled patients. PRGN-3006 is a novel T cell therapy designed to address hematologic malignancies with limited treatment options.
trial completionThe FDA has set an August 2025 PDUFA action date for PRGN-2012, a potential breakthrough therapy for recurrent respiratory papillomatosis (RRP).
fda decisionThe FDA has set a PDUFA target action date of August 27, 2025, for the review of PRGN-2012, a potential first therapy for recurrent respiratory papillomatosis.
fda decisionThe Phase 1 clinical trial evaluating PRGN-3007 UltraCAR-T cells in patients with advanced ROR1-positive hematologic malignancies, including CLL, MCL, ALL, DLBCL, and solid tumor TNBC, is expected to complete by March 1, 2026. The study, sponsored by H. Lee Moffitt Cancer Center and Research Institute, investigates the safety and preliminary efficacy of this investigational CAR-T cell therapy developed by Precigen (PGEN).
trial completionPrecigen's Phase 1/2 clinical trial of PRGN-2012 in adult patients with recurrent respiratory papillomatosis is projected to complete on June 5, 2026. The study evaluates the safety and efficacy of PRGN-2012, an investigational therapeutic candidate, across two dose levels. PRGN-2012 is a novel immunotherapy designed for the treatment of recurrent respiratory papillomatosis, a rare disease caused by HPV infection. The trial is no longer recruiting and enrolled 38 participants.
trial completionPrecigen is conducting a Phase 2 randomized trial (NCT06157151) evaluating PRGN-2009, an investigational immunotherapy, in combination with pembrolizumab versus pembrolizumab alone in patients with recurrent or metastatic cervical cancer resistant to pembrolizumab. The trial, which began in November 2024, is expected to complete on January 30, 2028. PRGN-2009 is a therapeutic vaccine targeting HPV-associated cancers. The study aims to assess efficacy and safety in a population with limited treatment options.
trial completionPrecigen is expected to complete its Phase I/Ib clinical trial of PRGN-3005, an autologous CAR T cell therapy, for patients with advanced, recurrent, platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer on 15 November 2028. The study aims to evaluate safety and determine the recommended dose of PRGN-3005, a genetically engineered cell therapy designed to target tumor cells. The trial is currently active but not recruiting, with an enrollment of 71 participants.
trial completionPrecigen's confirmatory Phase 3 trial of PRGN-2012, a therapeutic candidate for recurrent respiratory papillomatosis (RRP), is expected to complete on March 1, 2029. The single-arm, open-label study is evaluating efficacy and safety in patients with a history of repeated surgical debulking. PRGN-2012 is an investigational immunotherapy designed to address RRP, a rare disease caused by HPV infection.
trial completion