Welcome to our dedicated page for Precigen news (Ticker: PGEN), a resource for investors and traders seeking the latest updates and insights on Precigen stock.
Precigen, Inc. (Nasdaq: PGEN) is a biopharmaceutical company focused on precision medicines, and its news flow reflects the transition from a clinical-stage organization to a commercial-stage company. Recent announcements highlight full FDA approval and commercial launch of PAPZIMEOS (zopapogene imadenovec-drba), which the company describes as the first and only FDA-approved therapy for adults with recurrent respiratory papillomatosis (RRP). News items detail how PAPZIMEOS was discovered and designed using Precigen’s AdenoVerse platform and how it is being prescribed nationwide in the United States.
Investors and observers following PGEN news will see updates on PAPZIMEOS commercialization, including patient hub enrollment, payer coverage across private health plans and government programs, manufacturing and supply chain arrangements, and engagement with major medical centers and community practices. The company also issues news on long-term clinical data for PAPZIMEOS, emphasizing durable complete responses, reductions in surgery rates, and safety outcomes presented at medical meetings and in peer-reviewed publications.
Beyond PAPZIMEOS, Precigen’s news coverage includes pipeline developments such as progress in Phase 2 trials for PRGN-2009 in HPV-associated cancers and updates on PRGN-3006, an investigational UltraCAR-T therapy for acute myeloid leukemia and myelodysplastic syndromes. Financial results releases and related press statements provide context on capital resources, non-dilutive financing arrangements, preferred stock transactions, and the company’s expectations regarding funding operations through a projected cash flow break-even point.
Visitors to the PGEN news page can expect regular disclosures on regulatory milestones, conference presentations, investor webcasts, and business updates that illustrate how Precigen is advancing its precision medicine strategy and commercial execution around PAPZIMEOS and its broader pipeline.
Precigen (Nasdaq: PGEN) has appointed Phil Tennant as Chief Commercial Officer to lead commercial strategy and execution for potential launch of PRGN-2012 AdenoVerse gene therapy in recurrent respiratory papillomatosis (RRP). Tennant brings 30+ years of experience from biotech and pharma companies, including Merck, AstraZeneca, Bristol Myers Squibb, and Astellas Pharma. His expertise spans oncology, rare diseases, and global markets. At Astellas, he drove double-digit growth for a $5B oncology portfolio. Tennant will report to CEO Helen Sabzevari and join the executive leadership team, focusing on commercial readiness for PRGN-2012's potential US launch.
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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