Precigen Receives FDA Platform Technology Designation for AdenoVerse Platform

FDA platform technology designation for AdenoVerse may streamline Precigen’s future development and review of multiple oncology and RRP programs.

Rhea-AI Summary

Precigen (PGEN) received US FDA platform technology designation for its AdenoVerse immunotherapeutic platform, which underpins its first commercial product, PAPZIMEOS.

The FDA determined that AdenoVerse can be applied consistently across multiple products and is reasonably likely to create efficiencies in development, manufacturing and regulatory review. The designation allows Precigen to leverage data, existing manufacturing and preclinical knowledge from PAPZIMEOS to potentially accelerate future AdenoVerse-based programs, benefit from early and more frequent FDA engagement, obtain timely regulatory advice and rely on prior FDA manufacturing inspections where appropriate.

AdenoVerse currently supports PAPZIMEOS, approved in August 2025 as the first FDA-approved therapy for adults with recurrent respiratory papillomatosis, and Phase 2 trials of PRGN-2009 with pembrolizumab in HPV-associated oropharyngeal squamous cell carcinoma and in recurrent or metastatic cervical cancer, plus an open-label PAPZIMEOS redosing study in RRP.

Positive

• FDA platform technology designation granted for AdenoVerse platform
• PAPZIMEOS already FDA-approved for adults with recurrent respiratory papillomatosis
• PRGN-2009 in two Phase 2 trials for HPV-associated cancers
• Designation enables earlier and more frequent FDA engagement on future programs
• Ability to leverage PAPZIMEOS data and manufacturing knowledge for new candidates

Negative

• None.

Market Context

On Aug 4, Precigen reported $53.1 million in PAPZIMEOS net product revenue; the designation is tied ...

Analysis

On Aug 4, Precigen reported $53.1 million in PAPZIMEOS net product revenue; the designation is tied to the same FDA-approved product's AdenoVerse platform and potential reuse of its development data.

Key Figures

PAPZIMEOS FDA approval: August 2025

PAPZIMEOS FDA approval

August 2025

Prerequisite product for the AdenoVerse platform designation

Historical Context

1 past event · Latest: Aug 04

1 event

1. Aug 04

   2Q26 earnings report

   24h Move

   +5.5%

   Reported PAPZIMEOS revenue growth and net income as commercial product performance.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

platform technology designation, preclinical, oropharyngeal squamous cell carcinoma, open-label study, +1 more

5 terms

platform technology designation regulatory

"FDA granted platform technology designation to the AdenoVerse immunotherapeutic platform"

A platform technology designation means a company’s core scientific method, software, or manufacturing approach is recognized as a reusable foundation that can support multiple products or applications. For investors, it signals potential for faster product development, lower marginal costs and diversified revenue streams—like a single toolkit that can build many different devices—so the business can scale more efficiently and spread risk across several programs.

preclinical technical

"utilizing existing manufacturing and preclinical knowledge"

Preclinical describes the stage of drug or medical-product development when researchers test a candidate in the lab and in animals to see if it is safe, reaches intended targets, and shows basic effectiveness before any human trials begin. For investors, preclinical status signals an early, higher‑risk opportunity where positive lab results can increase value but significant work, time, and regulatory hurdles remain — like proofing a prototype in a workshop before road testing.

oropharyngeal squamous cell carcinoma medical

"patients with HPV-associated oropharyngeal squamous cell carcinoma"

A cancer that begins in the flat, thin cells lining the oropharynx—the middle portion of the throat that includes the back of the tongue, tonsils and soft palate—forming tumors that can interfere with swallowing, speech and breathing. Investors care because how common the disease is, the effectiveness of treatments and the results of clinical trials shape demand for drugs, medical devices, diagnostics and care services, similar to how a spike in demand for a car part affects related suppliers and repair shops.

open-label study medical

"An open-label study evaluating the efficacy of redosing PAPZIMEOS"

An open-label study is a type of research where both the participants and the researchers know which treatment or intervention is being administered. This transparency can influence the results, making it important for investors to consider potential biases or limitations when evaluating the study’s findings. Understanding this helps assess the reliability of evidence supporting new products or therapies.

recurrent respiratory papillomatosis medical

"treatment of adults with recurrent respiratory papillomatosis"

Recurrent respiratory papillomatosis is a rare condition in which benign but repeatedly returning growths form in the airways, especially the voice box and windpipe, causing hoarseness, breathing trouble and frequent need for medical procedures. For investors, it matters because the chronic, recurring nature of the disease drives ongoing demand for surgeries, drugs, and medical devices, and makes it a target for new therapies and regulatory reviews that can affect healthcare spending and company revenues.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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• Designation has the potential to accelerate development of current and future therapies built on Precigen's AdenoVerse platform

GERMANTOWN, Md., Sept. 21, 2026 /PRNewswire/ -- Precigen, Inc. (Nasdaq: PGEN), a commercial-stage biopharmaceutical company specializing in the advancement of innovative precision medicines to improve the lives of patients, today announced that the United States Food and Drug Administration (FDA) granted platform technology designation to the AdenoVerse^® immunotherapeutic platform, which is used in the company's first commercial product, PAPZIMEOS^®. The designation reflects the adaptability and potential of the platform to address a broad range of indications, including HPV-positive malignancies such as head and neck, cervical, anal, vulvar and vaginal cancers, as well as other diseases that may be targeted by future AdenoVerse-based product candidates.

FDA platform technology designation creates a pathway to leverage data generated for the development of PAPZIMEOS to potentially accelerate development of future AdenoVerse programs by utilizing existing manufacturing and preclinical knowledge to support future marketing applications and reduce duplication of development work. Platform technology designation provides opportunities for early FDA engagement, the ability to receive timely advice by having additional engagement with the FDA during development, and consideration of prior FDA manufacturing inspections for future applications.

To qualify for the platform technology designation, a platform must already be used in an FDA-approved product and the available evidence must demonstrate that it is well characterized, reproducible and has the potential to be adaptable across multiple products without compromising quality, manufacturing or safety. In granting this designation, the FDA determined that the AdenoVerse platform can be applied consistently across multiple products and is reasonably likely to generate meaningful efficiencies to the development or manufacturing process, and to the regulatory review process.

"This designation has the potential to accelerate the development of Precigen's broader AdenoVerse portfolio by allowing us to build on the technology established through PAPZIMEOS, which was approved by the FDA in August 2025. We expect the near-term impact will be especially meaningful for PRGN-2009 across multiple HPV-associated cancers, including cervical cancer and oropharyngeal squamous cell carcinoma. Importantly, the potential extends beyond PRGN-2009 to future AdenoVerse candidates such as those targeting additional cancers and other diseases," said Helen Sabzevari, PhD, President and CEO of Precigen. "We thank the FDA for recognizing the potential of the AdenoVerse platform. This designation will enable us to leverage prior data and engage with the FDA earlier and more frequently, creating opportunities to reduce duplicative work and bring greater speed, efficiency and predictability to the development of future AdenoVerse therapies."

AdenoVerse^® Clinical Portfolio

Precigen's AdenoVerse portfolio includes a Phase 2 study of PRGN-2009 in combination with pembrolizumab in newly diagnosed patients with HPV-associated oropharyngeal squamous cell carcinoma (NCT05996523) and a Phase 2 study of PRGN-2009 in combination with pembrolizumab in patients with recurrent or metastatic cervical cancer (NCT06157151). The portfolio also includes PAPZIMEOS^® (zopapogene imadenovec-drba; formerly PRGN-2012), which is the first FDA-approved therapy for the treatment of adults with recurrent respiratory papillomatosis (RRP). An open-label study evaluating the efficacy of redosing PAPZIMEOS in adults with RRP is currently enrolling (NCT06538480).

Precigen: Advancing Medicine with Precision^®

Precigen (Nasdaq: PGEN) is a commercial-stage biopharmaceutical company specializing in the advancement of innovative precision medicines to address difficult-to-treat diseases with high unmet patient need. Precigen is dedicated to advancing scientific breakthroughs from proof-of-concept through commercialization. With a strong commitment to innovation, Precigen is developing a robust pipeline of differentiated therapies across its core therapeutic areas of immuno-oncology, autoimmune disorders, and infectious diseases. For more information about Precigen, visit www.precigen.com or follow us on LinkedIn or YouTube.

Trademarks

Precigen, PAPZIMEOS, AdenoVerse, and Advancing Medicine with Precision are trademarks of Precigen and/or its affiliates. Other names may be trademarks of their respective owners.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains "forward-looking" statements within the meaning of the safe harbor provisions of the US Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: "anticipate," "intend," "plan," "goal," "seek," "believe," "project," "estimate," "expect," "strategy," "future," "likely," "may," "should," "will" and similar references to future periods. These statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from what the Company expects. Examples of forward-looking statements include, among others, potential development efficiencies the platform technology designation may provide to accelerate the development of the Company's AdenoVerse clinical portfolio, potential benefits of the platform technology designation, information relating to the Company's business and business plans, the success of efforts to commercialize PAPZIMEOS^® (zopapogene imadenovec-drba) for the treatment of recurrent respiratory papillomatosis (RRP) in adults, the Company's ability to successfully obtain foreign regulatory approvals for PAPZIMEOS, expectations about the safety and efficacy of PAPZIMEOS, the ability of PAPZIMEOS to treat RRP, the Company's future financial and operational results, and the Company's ability to commence clinical studies or complete ongoing clinical studies for the Company's clinical and pre-clinical stage candidates. The Company has no obligation to provide any updates to these forward-looking statements even if its expectations change. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. For further information on potential risks and uncertainties, and other important factors, any of which could cause the Company's actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in the Company's most recent Annual Report on Form 10-K and subsequent reports filed with the Securities and Exchange Commission.

Investor Contact:

Steven M. Harasym
Tel: +1 (202) 365-2563
investors@precigen.com

Media Contact:

Donelle M. Gregory
press@precigen.com

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SOURCE Precigen, Inc.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What does FDA platform technology designation allow Precigen to do with AdenoVerse-based products?

Platform technology designation creates a pathway to leverage data from PAPZIMEOS to potentially accelerate development of future AdenoVerse programs. The company can use existing manufacturing and preclinical knowledge to support future marketing applications, reduce duplicative development work, engage with the FDA earlier and more frequently, receive timely advice and have prior FDA manufacturing inspections considered for future applications.

What criteria had to be met for AdenoVerse to receive platform technology designation?

To qualify, the platform must already be used in an FDA-approved product, and available evidence must show it is well characterized and reproducible, with potential to be adaptable across multiple products without compromising quality, manufacturing or safety. The FDA concluded that AdenoVerse can be applied consistently across multiple products and is reasonably likely to generate meaningful efficiencies in development, manufacturing and regulatory review.

Which current clinical programs are part of Precigen’s AdenoVerse portfolio?

The AdenoVerse portfolio includes: a Phase 2 study of PRGN-2009 plus pembrolizumab in newly diagnosed HPV-associated oropharyngeal squamous cell carcinoma (NCT05996523); a Phase 2 study of PRGN-2009 plus pembrolizumab in recurrent or metastatic cervical cancer (NCT06157151); and an open-label study evaluating PAPZIMEOS redosing in adults with recurrent respiratory papillomatosis (NCT06538480).

For which conditions is PAPZIMEOS currently approved and how is it positioned in Precigen’s pipeline?

PAPZIMEOS (zopapogene imadenovec-drba; formerly PRGN-2012) is the first FDA-approved therapy for the treatment of adults with recurrent respiratory papillomatosis (RRP). It is the company’s first commercial product using the AdenoVerse platform and serves as the foundational program whose data, manufacturing and preclinical knowledge can be leveraged to support future AdenoVerse-based therapies.