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
PAPZIMEOS and PRGN-2012. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
PAPZIMEOS FDA Regulatory Timeline and Events
PAPZIMEOS is a drug developed by Precigen for the following indication: For Treatment Of Adults With Recurrent Respiratory Papillomatosis.
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:
- PAPZIMEOS
- Announced Date:
- May 30, 2026
- Indication:
- For Treatment Of Adults With Recurrent Respiratory Papillomatosis
Announcement
Precigen, Inc. announced updated long-term follow-up data from the pivotal study of PAPZIMEOS™ (zopapogene imadenovec-drba) for the treatment of adults with recurrent respiratory papillomatosis (RRP). Updated durability of response data were presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago in a presentation titled, "Zopapogene imadenovec-drba, a novel non-replicating adenoviral vector-based immunotherapy: Effects on complete and durable responses in recurrent respiratory papillomatosis pivotal trial."
AI Summary
Precigen said updated long-term follow-up data from the pivotal study of PAPZIMEOS™ (zopapogene imadenovec-drba) were presented at the 2026 ASCO Annual Meeting. PAPZIMEOS is a non-replicating adenoviral vector-based immunotherapy for adults with recurrent respiratory papillomatosis (RRP), a rare condition that causes growths in the airway. The presentation focused on how well the treatment worked over time and how durable the complete responses were in patients from the pivotal trial.
The update highlighted continued response durability, supporting the idea that PAPZIMEOS may offer lasting benefit for some adults with RRP. Precigen also noted important safety information: reactions at the injection site can happen, and patients are monitored after the first dose. The company warned about possible serious allergic reactions and thrombotic events, and advised patients to contact a doctor right away if symptoms like trouble breathing, chest pain, swelling, severe headache, or blurred vision occur.
Read Announcement- Drug:
- PAPZIMEOS
- Announced Date:
- May 27, 2026
- Indication:
- For Treatment Of Adults With Recurrent Respiratory Papillomatosis
Announcement
Precigen, Inc. announced that the US Food and Drug Administration (FDA) has granted orphan drug exclusivity for PAPZIMEOS™ (zopapogene imadenovec-drba) for the treatment of adults with recurrent respiratory papillomatosis (RRP).
AI Summary
Precigen, Inc. said the U.S. Food and Drug Administration has granted orphan drug exclusivity for PAPZIMEOS™ (zopapogene imadenovec-drba), a treatment for adults with recurrent respiratory papillomatosis (RRP). This status is given to drugs for rare diseases that affect fewer than 200,000 people in the United States. The exclusivity means PAPZIMEOS will have seven years of market protection in the U.S., lasting through August 14, 2032.
RRP is a condition in which growths, called papillomas, form in the airways and can cause serious breathing problems. PAPZIMEOS is an immunotherapy designed to help treat this disease in adults. Precigen said the FDA’s decision supports the drug’s role as a rare-disease treatment and gives the company a longer period to market it without direct competition for the same use.
Read Announcement- Drug:
- PAPZIMEOS
- Announced Date:
- January 20, 2026
- Indication:
- For Treatment Of Adults With Recurrent Respiratory Papillomatosis
Announcement
Precigen, Inc. announced the publication of a new expert consensus paper sponsored by the Recurrent Respiratory Papillomatosis Foundation (RRPF) and authored by 16 leading physicians in the field of recurrent respiratory papillomatosis (RRP) has been published in The Laryngoscope, one of the field's most respected peer-reviewed journals.
AI Summary
Precigen announced that a new expert consensus paper, sponsored by the Recurrent Respiratory Papillomatosis Foundation and authored by 16 leading RRP physicians, was published in The Laryngoscope. The paper recommends PAPZIMEOS (zopapogene imadenovec) as the new standard first-line treatment for adults with recurrent respiratory papillomatosis (RRP), replacing the long-standing reliance on repeated surgery.
The authors argue that PAPZIMEOS treats the underlying HPV infection and can offer durable disease control for responders. The paper urges early consideration of therapy to reduce risks associated with repeat surgeries, promotes shared decision-making, and calls for a multidisciplinary care approach. Developed with input from patients and caregivers, the consensus provides practical guidance for clinicians and patients and aims to shift RRP management toward lasting disease control rather than symptom-only surgical relief.
Read Announcement- Drug:
- PAPZIMEOS
- Announced Date:
- January 12, 2026
- Indication:
- For Treatment Of Adults With Recurrent Respiratory Papillomatosis
Announcement
Precigen, today provided an update on the rapid commercialization momentum and growing market adoption of PAPZIMEOSTM (zopapogene imadenovec-drba), the first-and-only US Food and Drug Administration (FDA)-approved therapy for recurrent respiratory papillomatosis (RRP).
AI Summary
Precigen provided an update on the rapid commercialization and growing market adoption of PAPZIMEOS, the first-and-only FDA‑approved therapy for recurrent respiratory papillomatosis (RRP). Commercial activity is underway nationwide: PAPZIMEOS is being prescribed and patients are actively receiving treatment. The sales team has engaged over 96% of target centers, manufacturing and cold‑chain logistics are in place, and the PAPZIMEOS patient hub has registered more than 200 patients, doubling since November and showing demand across major medical centers and community practices.
Payer coverage is expanding, with roughly 170 million US lives covered by private plans, plus Medicare and Medicaid. The European Medicines Agency has validated the Marketing Authorization Application for PAPZIMEOS, and Precigen expects current capital to fund operations through cash‑flow break‑even. The company says the momentum supports broader adoption as PAPZIMEOS becomes an established treatment option for adults with RRP.
Read Announcement- Drug:
- PAPZIMEOS
- Announced Date:
- October 13, 2025
- Indication:
- For Treatment Of Adults With Recurrent Respiratory Papillomatosis
Announcement
Precigen, Inc. announced long-term follow-up data demonstrating durable responses to PAPZIMEOS™ (zopapogene imadenovec-drba) for the treatment of adults with recurrent respiratory papillomatosis (RRP).
AI Summary
Precigen, Inc. reported long-term follow-up results showing that PAPZIMEOS™ (zopapogene imadenovec-drba) produced lasting benefits in adults with recurrent respiratory papillomatosis (RRP). The data highlight strong, durable responses well beyond the first year of treatment.
Of the 18 patients who initially achieved a complete response, 15 (83%) maintained that response at a median follow-up of 36 months. The median duration of complete response has not yet been reached, indicating continued disease control for many patients.
Surgical demand dropped sharply after treatment. Compared to the year before PAPZIMEOS, 86% of patients needed fewer surgeries in Year 1, 91% in Year 2, and 95% in Year 3. No new safety issues were observed during the extended follow-up.
These findings suggest PAPZIMEOS offers a transformative option for RRP patients, reducing repetitive surgeries and improving quality of life through sustained immune-driven control of the disease.
Read Announcement- Drug:
- PAPZIMEOS
- Announced Date:
- August 15, 2025
- Indication:
- For Treatment Of Adults With Recurrent Respiratory Papillomatosis
Announcement
Precigen, Inc. announced that the US Food and Drug Administration (FDA) has approved PAPZIMEOS™ (zopapogene imadenovec-drba) for the treatment of adults with recurrent respiratory papillomatosis (RRP). PAPZIMEOS is the first and only FDA-approved therapy for the treatment of adults with RRP.
Read Announcement
PRGN-2012 FDA Regulatory 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
