FDA Events for Precigen (PGEN)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Precigen (PGEN).
Over the past two years, Precigen has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
PRGN-2012. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
PRGN-2012 - FDA Regulatory Timeline and Events
PRGN-2012 is a drug developed by Precigen for the following indication: Recurrent Respiratory Papillomatosis (RRP).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- PRGN-2012
- Announced Date:
- February 25, 2025
- Indication:
- Recurrent Respiratory Papillomatosis (RRP)
Announcement
Precigen, Inc. announced the US Food and Drug Administration (FDA) has accepted the company's biologics license application (BLA) for PRGN-2012 (nonproprietary name: zopapogene imadenovec†), an investigational AdenoVerse® gene therapy for the treatment of adults with recurrent respiratory papillomatosis (RRP).
AI Summary
Precigen, Inc. announced that the US Food and Drug Administration (FDA) has accepted its biologics license application (BLA) for PRGN-2012, the investigational gene therapy known as zopapogene imadenovec. This therapy is being developed to treat adults with recurrent respiratory papillomatosis (RRP), a rare disease where patients currently depend on repeated surgeries for relief. The FDA granted a Priority Review for this application, reducing the review timeline to six months. If approved, PRGN-2012 would become the first FDA-approved treatment available for RRP, offering a potentially significant improvement by targeting the underlying cause of the condition. The therapy works by triggering immune responses against cells infected with HPV6 or HPV11, aiming to lessen the need for extensive surgical interventions and improve the quality of life for patients. This acceptance marks an important step forward in addressing a critical unmet medical need.
Read Announcement- Drug:
- PRGN-2012
- Announced Date:
- December 30, 2024
- Indication:
- Recurrent Respiratory Papillomatosis (RRP)
Announcement
Precigen, announced the completion of the rolling submission for a biologics license application (BLA) to the US Food and Drug Administration (FDA) for PRGN-2012 (INN: zopapogene imadenovec†) for the treatment of adult patients with recurrent respiratory papillomatosis (RRP).
AI Summary
Precigen, Inc. announced that it has completed its rolling submission of a biologics license application (BLA) to the US FDA for PRGN-2012 (zopapogene imadenovec), a new gene therapy for adult patients suffering from recurrent respiratory papillomatosis (RRP). RRP is a rare, lifelong disease currently managed only by repeated surgeries. This BLA submission, made under an accelerated approval pathway, marks a crucial step toward potentially offering the first FDA-approved treatment for this devastating condition.
During the initial 60-day review period, the FDA will decide whether to accept the application for further evaluation and set a Prescription Drug User Fee Act (PDUFA) date. If granted, the requested priority review could shorten the approval process from the standard 10-month timeline to just six months. This follows promising Phase 1/2 data showing significant clinical benefits and a favorable safety profile.
Read Announcement- Drug:
- PRGN-2012
- Announced Date:
- June 3, 2024
- Estimated Event Date Range:
- July 1, 2024 - December 31, 2024
- Target Action Date:
- H2 2024
- Indication:
- Recurrent Respiratory Papillomatosis (RRP)
Announcement
Precigen, Inc. announced that PRGN-2012 rolling BLA submission, under an accelerated approval pathway, is anticipated in the second half of 2024 –
AI Summary
Precigen, Inc. announced that it plans to submit a rolling Biologics License Application for its PRGN-2012 gene therapy in the second half of 2024 under an accelerated approval pathway. PRGN-2012 is being developed as a treatment for recurrent respiratory papillomatosis (RRP), a challenging condition that causes benign tumors in the respiratory tract. In a recent pivotal Phase 1/2 study, the therapy met key safety and efficacy endpoints, with over half the patients achieving a complete response and most requiring fewer surgeries after treatment.
The results from the study, which demonstrated a strong safety profile and significant improvement in patient outcomes, support the upcoming submission. If approved by the FDA, PRGN-2012 has the potential to become the first therapy of its kind for RRP, offering new hope for patients who currently rely on repeated surgeries to manage the disease.
Read Announcement- Drug:
- PRGN-2012
- Announced Date:
- June 3, 2024
- Indication:
- Recurrent Respiratory Papillomatosis (RRP)
Announcement
Precigen, today released positive Phase 1/2 pivotal study results for the investigational PRGN-2012 off-the-shelf (OTS) AdenoVerse® gene therapy in patients with recurrent respiratory papillomatosis (RRP)
AI Summary
Precigen today announced positive results from a Phase 1/2 pivotal study of its investigational PRGN-2012 off-the-shelf AdenoVerse® gene therapy for patients with recurrent respiratory papillomatosis (RRP). The study met its primary safety and efficacy goals, with 51% of patients achieving a Complete Response, meaning they did not need any further surgeries during the 12-month follow-up period. Additionally, 86% of patients experienced a notable decrease in surgeries, with a reduction from a median of four surgeries before treatment to none after treatment. The therapy was well tolerated, showed durable effects beyond 12 months, and induced strong HPV-specific T cell responses. Based on these encouraging results, Precigen plans to move forward with a rolling Biologics License Application submission under an accelerated approval pathway later in 2024.
Read Announcement- Drug:
- PRGN-2012
- Announced Date:
- May 23, 2024
- Estimated Event Date Range:
- June 3, 2024 - June 3, 2024
- Target Action Date:
- June 03, 2024
- Indication:
- Recurrent Respiratory Papillomatosis (RRP)
Announcement
Precigen, Inc. announced that the Company will host a webcast on June 3, 2024 at 6:00 PM CT/7:00 PM ET following the late-breaking oral presentation of results from the pivotal study of PRGN-2012 for the treatment of recurrent respiratory papillomatosis (RRP) at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting.
AI Summary
Precigen, Inc. announced that it will host a webcast on June 3, 2024 at 6:00 PM CT/7:00 PM ET. This event will take place right after the late-breaking oral presentation of the pivotal study results of PRGN-2012 for treating recurrent respiratory papillomatosis (RRP) at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. The webcast is set to provide a detailed review of the study’s data and a business update from the company.
The presentation at ASCO, which highlights meaningful progress in the treatment of RRP, draws attention to PRGN-2012’s potential as a novel immunotherapy. Interested participants can register and view the webcast through Precigen’s website, where an archived recording will also be made available afterward.
Read Announcement
Precigen FDA Events - Frequently Asked Questions
As of now, Precigen (PGEN) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Precigen (PGEN) has reported FDA regulatory activity for PRGN-2012.
The most recent FDA-related event for Precigen occurred on February 25, 2025, involving PRGN-2012. The update was categorized as "FDA Accepted," with the company reporting: "Precigen, Inc. announced the US Food and Drug Administration (FDA) has accepted the company's biologics license application (BLA) for PRGN-2012 (nonproprietary name: zopapogene imadenovec†), an investigational AdenoVerse® gene therapy for the treatment of adults with recurrent respiratory papillomatosis (RRP)."
Currently, Precigen has one therapy (PRGN-2012) targeting the following condition: Recurrent Respiratory Papillomatosis (RRP).
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:PGEN) was last updated on 7/12/2025 by MarketBeat.com Staff
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