Precigen, Inc.

Precigen Receives FDA Platform Technology Designation for AdenoVerse Platform

Precigen received FDA platform technology designation for its AdenoVerse immunotherapeutic platform, the technology behind its first commercial product PAPZIMEOS. The designation lets Precigen leverage existing manufacturing and preclinical data from PAPZIMEOS, FDA-approved in August 2025 for recurrent respiratory papillomatosis, to support future marketing applications with earlier and more frequent FDA engagement and consideration of prior manufacturing inspections. Management expects the near-term benefit to be most meaningful for PRGN-2009, now in Phase 2 trials with pembrolizumab in HPV-associated oropharyngeal squamous cell carcinoma and recurrent or metastatic cervical cancer, with potential extending to future AdenoVerse candidates.

•1mo ago

Precigen's Strong Second Quarter Signals Significant Growth, Validates AdenoVerse Platform; PRGN-2009 Advances in HPV-Driven Cancers

Precigen reported a strong Q2 commercial performance with PAPZIMEOS generating $53.1 million in net product revenue, more than doubling the prior quarter and driving quarterly profitability. The company advanced its oncology pipeline, reporting that PRGN-2009 showed a 20-30% objective response rate and 24.6-month median overall survival in a Phase 1 combination study for HPV-driven cancers. PAPZIMEOS now holds a permanent J-code and broad payer coverage, backed by FDA market exclusivity through August 2032, while multiple Phase 2 trials for PRGN-2009 are ongoing.

•2mo ago

Precigen Reports Second Quarter 2026 Financial Results Highlighted by Accelerating PAPZIMEOS Revenue Growth

Precigen reported Q2 total revenue of $55.0 million, driven by $53.1 million in PAPZIMEOS net revenue which more than doubled from the prior quarter. The company achieved profitability with net income of $20.1 million, or $0.05 per diluted share, compared to a net loss of $26.6 million in the prior-year period. Management reiterated that current cash of $38.7 million and product sales will support operations through cash flow break-even by the end of 2026, bolstered by 7-year FDA exclusivity and broad payer coverage.

•2mo ago

Precigen Gains Advantage as PAPZIMEOS Granted Orphan Drug Exclusivity by FDA; Long-Term Data From Clinical Study Encouraging

Precigen secured FDA orphan drug exclusivity for PAPZIMEOS, its treatment for recurrent respiratory papillomatosis (RRP), granting seven years of market protection through August 2032. This regulatory win coincides with the release of encouraging long-term durability data from the pivotal study presented at ASCO, showing 83% of complete responders maintained their response for at least 36 months without additional treatment. Five patients in the study remained surgery-free beyond four years, with no new safety events observed, reinforcing the drug's position as a new standard of care for a disease historically managed through repeated surgeries.

•4mo ago

Precigen Presents New Long-Term Durability Data for PAPZIMEOS, Recently Granted Seven-Year Market Exclusivity, Demonstrating Complete Responses Beyond 4 Years

Precigen presented updated long-term durability data for PAPZIMEOS at the ASCO Annual Meeting, showing that 83% of complete responders maintained their response for at least 36 months without additional treatment. Five patients have demonstrated ongoing complete responses beyond four years, with no new adverse safety events observed during the extended follow-up period. The data reinforces PAPZIMEOS as the first and only FDA-approved therapy for adult recurrent respiratory papillomatosis (RRP), supporting its position as the new standard of care for a disease historically managed through repeated surgeries.

•5mo ago

Precigen Receives Orphan Drug Exclusivity for PAPZIMEOS (zopapogene imadenovec-drba) in the United States

The FDA granted orphan drug exclusivity to Precigen's PAPZIMEOS for the treatment of adults with recurrent respiratory papillomatosis (RRP). This regulatory designation provides seven years of market exclusivity in the US, effective through August 14, 2032. PAPZIMEOS is the first and only FDA-approved therapy for adult RRP, a rare disease affecting approximately 27,000 adults in the US, and is currently being prescribed nationwide.

•5mo ago

Precigen Reports First Quarter 2026 Financial Results and Business Updates

Precigen reported Q1 2026 revenue of $23.252 million, with $21.6 million from the launch of PAPZIMEOS, reflecting strong commercial uptake. Patient hub enrollment for PAPZIMEOS reached approximately 400 patients, with 25% from the community setting, underscoring broad reach and ease of administration. The company will present updated durability of response data for PAPZIMEOS at the upcoming ASCO Annual Meeting, further validating its clinical performance. Cash, cash equivalents, and investments totaled $56.7 million as of March 31, 2026, which, along with anticipated PAPZIMEOS revenue, is expected to fund operations to cash flow break-even by the end of 2026.

•5mo ago