Precigen, Inc. PGEN
Precigen, Inc. (Nasdaq: PGEN) is an infectious disease drug developer. Its lead program, Papzimeos (zopapogene imadenovec-drba, PRGN-2012), is in Phase 2 for Recurrent Respiratory Papillomatosis (RRP) in adults. Its next catalyst on record is Papzimeos: EMA MAA review decision (date not stated).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: Papzimeos — EMA MAA review decision (date not stated). 1 catalyst on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| Papzimeos (zopapogene imadenovec-drba, PRGN-2012) | RRP in adults | gene therapy | Approved |
| PRGN-2009 | Newly-diagnosed HPV-associated oropharyngeal cancer / recurrent or metastatic cervical cancer | gene therapy | Phase 2 |
| zopapogene imadenovec-drba redosing trial | RRP in adults (redosing) | gene therapy | Phase 1 |
| PRGN-3006 | Relapsed or refractory AML and high-risk MDS | cell therapy | Phase 1 |
| PRGN-3005 | Advanced, recurrent platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer | cell therapy | Phase 1 |
| PRGN-3007 | Advanced ROR1+ hematological and solid tumors | cell therapy | Phase 1 |
| zopapogene imadenovec-drba pediatric | Pediatric RRP | gene therapy | Pre-clinical |
Recent results and decisions
- Nov 5, 2026started Enrollment is ongoing in an open-label study to evaluate redosing efficacy of zopapogene imadenovec in adults with RRP.
Enrollment in the Company's open-label study to evaluate redosing efficacy of zopapogene imadenovec in adults with RRP is ongoing (clinical trial identifier: NCT06538480).
Filing - Nov 5, 2026positive The Company plans to present new Phase 2 clinical data from its PRGN-2009 program in newly diagnosed HPV-associated oropharyngeal cancer at a forthcoming R&D Day.
The Company plans to present new Phase 2 clinical data from its PRGN-2009 program in newly diagnosed HPV-associated oropharyngeal cancer at a forthcoming R&D Day, together with a comprehensive update on PRGN-2009 and its broader AdenoVerse development strategy.
Filing - Nov 1, 2025submitted The EMA validated and is reviewing the Marketing Authorization Application submitted in November 2025 for zopapogene imadenovec for adults with RRP.
The European Medicines Agency (EMA) has validated and is reviewing the Marketing Authorization Application (MAA) submitted in November 2025 for zopapogene imadenovec for the treatment of adults with RRP.
Filing
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 2 infectious disease companies
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.