Precigen, Inc. reports developments as a commercial-stage biopharmaceutical company advancing precision medicines for difficult-to-treat diseases. Its news centers on PAPZIMEOS (zopapogene imadenovec-drba), an FDA-approved therapy for adults with recurrent respiratory papillomatosis, including commercialization, access, reimbursement, medical-publication updates, and adoption by treating physicians.
Company updates also cover financial results, business presentations, and pipeline activity across immuno-oncology, autoimmune disorders, and infectious diseases. Precigen’s recurring technology references include the AdenoVerse immunotherapy platform, UltraCAR-T programs, and related manufacturing capabilities used to support its precision-medicine portfolio.
Precigen announced positive results from its Phase 1/2 pivotal study for PRGN-2012, a gene therapy for recurrent respiratory papillomatosis (RRP). In the study, 51% of patients achieved complete response, with no surgeries required post-treatment. Additionally, 86% of patients saw reduced surgical interventions. The treatment was well-tolerated, with no severe adverse events reported. The study showed significant improvements in patient quality of life and reduced disease severity. Precigen plans to submit a Biologics License Application (BLA) under an accelerated approval pathway in the second half of 2024, aiming for a potential launch in 2025.
Precigen (Nasdaq: PGEN) will host a webcast on June 3, 2024, at 6:00 PM CT/7:00 PM ET to discuss pivotal study results of PRGN-2012 for treating recurrent respiratory papillomatosis (RRP). The data will be presented earlier that day at 8:30 AM CT during the 2024 ASCO Annual Meeting. This Phase 2 study, led by Dr. Scott M. Norberg, demonstrates that PRGN-2012, a gorilla adenovirus-based immunotherapy, provides complete and durable responses in RRP patients. Participants can register and access the webcast via Precigen's website, and an archived recording will be available post-event. Precigen focuses on gene and cell therapies for immuno-oncology, autoimmune disorders, and infectious diseases, leveraging its AdenoVerse platform for advanced gene delivery and therapy development.
Precigen announced its Q1 2024 financial results and business updates, including pivotal Phase 2 data for PRGN-2012 to be presented at the ASCO Annual Meeting on June 3, 2024. A rolling BLA submission for PRGN-2012 is anticipated in the second half of 2024, with commercial readiness activities underway for a potential 2025 launch. Financially, the company reported $44.8 million in cash, cash equivalents, and short-term investments as of March 31, 2024, with a net loss of $23.7 million or $(0.10) per share. R&D expenses increased by 17%, while SG&A costs decreased by 13%. Key initiatives include PRGN-2009 trials for HPV-associated cancers and PRGN-3006 and PRGN-3005 trials for AML/MDS and ovarian cancer, respectively.
Precigen, Inc. (Nasdaq: PGEN) will report first quarter 2024 financial results on May 14, 2024, with a conference call on June 3, 2024. The company will discuss pivotal Phase 2 study data of PRGN-2012 for recurrent respiratory papillomatosis (RRP) at the 2024 ASCO Annual Meeting. Precigen focuses on gene and cell therapies for immuno-oncology, autoimmune disorders, and infectious diseases.
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