Precigen Showcases Rapid Commercialization Momentum and Growing Market Adoption of First-and-Only FDA-Approved Therapy for RRP at the 44th Annual J.P. Morgan Healthcare Conference

Rhea-AI Summary

Precigen (Nasdaq: PGEN) reported rapid commercialization and growing adoption of PAPZIMEOS, the first-and-only FDA-approved therapy for adults with recurrent respiratory papillomatosis (RRP). Key highlights include FDA full approval in August 2025 with a broad label and no confirmatory trial requirement, patient-hub enrollment >200 (doubling since November), private health plan coverage for ~170 million US lives, Medicare and Medicaid coverage, and EMA validation of the Marketing Authorization Application following a November 2025 submission. The company says manufacturing, cold-chain logistics, and field engagement (>96% of target centers) are in place and expects current capital resources to fund operations through anticipated cash-flow break-even.

Positive

• FDA full approval of PAPZIMEOS in August 2025 with broad label
• Patient-hub enrollment >200, doubling since November
• Private payer coverage of ~170 million US lives, plus Medicare and Medicaid
• EMA validated Marketing Authorization Application after Nov 2025 submission
• Field engagement exceeding 96% of target centers since September launch

Negative

• Registered patient base remains small at just over 200 patients to date

News Market Reaction

-9.91%

32 alerts

-9.91% News Effect

-4.3% Trough in 5 hr 40 min

-$167M Valuation Impact

$1.51B Market Cap

1.0x Rel. Volume

On the day this news was published, PGEN declined 9.91%, reflecting a notable negative market reaction. Argus tracked a trough of -4.3% from its starting point during tracking. Our momentum scanner triggered 32 alerts that day, indicating elevated trading interest and price volatility. This price movement removed approximately $167M from the company's valuation, bringing the market cap to $1.51B at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

PAPZIMEOS patient hub: more than 200 registered patients Private coverage: approximately 170 million US lives Target center engagement: over 96% engaged +5 more

8 metrics

PAPZIMEOS patient hub more than 200 registered patients PAPZIMEOS commercialization update; enrollment doubled since November 2025

Private coverage approximately 170 million US lives Private health plan coverage for PAPZIMEOS, plus Medicare and Medicaid

Target center engagement over 96% engaged US target centers engaged since full sales deployment in September 2025

FDA approval date August 2025 Full FDA approval of PAPZIMEOS for adults with RRP

EMA MAA validation November 2025 submission; validation complete Marketing Authorization Application for PAPZIMEOS in adults with RRP

Conference presentation January 15, 2026 at 7:30 AM PT Company presentation at the 44th J.P. Morgan Healthcare Conference

Current price $4.59 Pre-news share price, about 12.15% below 52-week high

52-week range $1.05 – $5.225 Pre-news 52-week low and high for PGEN

Market Reality Check

Price: $4.46 Vol: Volume 3,488,486 is below...

low vol

$4.46 Last Close

Volume Volume 3,488,486 is below the 20-day average of 5,467,351, suggesting subdued pre-news activity. low

Technical Shares at $4.59 were trading above the 200-day MA of $2.75, and about 12.15% below the 52-week high of $5.225.

Peers on Argus

PGEN was modestly lower (-0.43%) while only one momentum peer, STOK, showed a sh...

1 Down

PGEN was modestly lower (-0.43%) while only one momentum peer, STOK, showed a sharp move (-20.24%) without news. Other close peers (e.g., ZYME, GPCR, RCUS, NTLA, TRML) had mixed, mostly small moves, indicating the commercialization update was company-specific rather than part of a broad biotech rotation.

Historical Context

5 past events · Latest: Jan 05 (Neutral)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Jan 05	Conference presentation	Neutral	-2.3%	J.P. Morgan Healthcare Conference presentation and related investor events.
Nov 13	Earnings and launch update	Positive	-4.0%	Q3 2025 results with PAPZIMEOS approval, hub uptake, and financing details.
Nov 06	Earnings date notice	Neutral	-0.5%	Announcement of timing for Q3 2025 earnings and business update call.
Oct 13	Clinical follow-up data	Positive	+2.9%	Long-term durable complete response data for PAPZIMEOS in RRP.
Sep 03	Non-dilutive financing	Positive	-0.2%	Up to $125M credit facility to support PAPZIMEOS commercialization and expansion.

Pattern Detected

Recent history shows generally positive fundamental news around PAPZIMEOS and financing, but share reactions have often been muted or negative, with only one clear positive move on strong clinical follow-up data.

Recent Company History

Over the last several months, Precigen has transitioned around PAPZIMEOS from pivotal data to full FDA approval and commercialization. A Sept 2025 non-dilutive credit facility of up to $125M supported launch efforts, followed by long‑term durable response data in Oct 2025. Q3 2025 results in Nov 2025 highlighted initial hub enrollment and higher expenses from launch preparation. More recently, the company announced participation at the 44th J.P. Morgan Healthcare Conference. Today’s update extends this trajectory with detailed adoption and access metrics for PAPZIMEOS.

Regulatory & Risk Context

Active S-3 Shelf

Shelf Active

Active S-3 Shelf Registration 2025-08-19

An effective Form S-3 shelf filed on 2025-08-19 registers secondary sales of up to 143,809,489 common and 79,000 preferred shares for selling stockholders, with the company receiving no proceeds. This structure allows existing holders, including concentrated owners, flexibility to sell via various methods without direct capital raise by the issuer.

Market Pulse Summary

The stock moved -9.9% in the session following this news. A negative reaction despite clearly positi...

Analysis

The stock moved -9.9% in the session following this news. A negative reaction despite clearly positive commercialization metrics would fit a pattern where prior favorable PAPZIMEOS and financing updates sometimes preceded weak price performance. The stock had traded above its 200-day MA and well above the $1.05 52‑week low, so expectations may already have been elevated. The existing Form S-3 for secondary sales, along with concentrated ownership, could also influence how new demand interacted with potential selling pressure.

Key Terms

fda, medicare, medicaid, european medicines agency, +4 more

8 terms

fda regulatory

"the first-and-only US Food and Drug Administration (FDA)-approved therapy"

The FDA is the U.S. federal agency that evaluates and approves medical drugs, devices, biological therapies and certain foods; think of it as the gatekeeper that decides whether a medical product is safe and effective for patients. For investors, FDA decisions determine whether a company can sell a product, affect expected revenue and introduce regulatory risk, so approvals, rejections or safety warnings can quickly move a company's valuation and stock price.

medicare regulatory

"PAPZIMEOS is also covered under Medicare and Medicaid"

Medicare is a large government-run health insurance program that primarily covers people aged 65 and older and certain younger people with disabilities. For investors it matters because Medicare acts like a huge customer and rule-maker for hospitals, drugmakers and medical-device companies—its coverage decisions, payment rates and regulatory policies can change demand, revenue and profit margins across the healthcare sector, similar to how a major client or regulator can shape a business’s prospects.

medicaid regulatory

"PAPZIMEOS is also covered under Medicare and Medicaid"

Medicaid is a government-funded health insurance program that provides medical coverage to low-income individuals, families, elderly people and people with disabilities, administered jointly by the federal government and state governments in the United States. For investors, Medicaid matters because changes in eligibility, funding, or payment rules can alter patient volume and the prices hospitals, nursing homes, insurers and medical suppliers receive—similar to how a large customer or contract can shift a company’s revenue outlook.

european medicines agency regulatory

"The European Medicines Agency has validated the Marketing Authorization Application"

The European Medicines Agency is the central drug regulator that evaluates and authorizes medicines for use across the European Union and related countries, similar to a referee or safety inspector who checks that a medicine is safe and effective before it can be sold. Its decisions matter to investors because approvals, rejections, or safety warnings directly affect a drug maker’s ability to sell products, generate revenue, and face legal or reputational risks, which in turn influence stock value.

marketing authorization application regulatory

"validated the Marketing Authorization Application for PAPZIMEOS"

A marketing authorization application is a formal request submitted to a government regulator asking permission to sell a prescription medicine or medical product in a country or region. Think of it like asking for a business license after showing evidence the product is safe and works; investors care because approval determines whether the product can generate sales, how soon revenue starts, and how much regulatory risk and uncertainty remains.

recurrent respiratory papillomatosis medical

"therapy for recurrent respiratory papillomatosis (RRP)"

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.

cold-chain logistics technical

"supported by established cold-chain logistics and coordinated solutions"

Cold-chain logistics is the storage and transport system that keeps temperature-sensitive products (like vaccines, biologics, food, or chemicals) within strict temperature ranges from production to end use, using refrigerated trucks, insulated packaging, climate-controlled warehouses and continuous temperature monitoring. It matters to investors because failures can spoil products, trigger recalls, or block sales, affecting revenue, regulatory risk and margins—think of it as a refrigerated relay race where a single broken link can destroy value.

standard of care medical

"as the preferred first-line treatment and new standard of care"

Standard of care is the accepted medical treatment or clinical approach that most qualified doctors would use for a given condition today, based on available evidence, guidelines and common practice. For investors, it acts like the baseline product customers expect: a new therapy or device must match or improve on the standard of care to win market share, gain reimbursement and limit legal or regulatory risk.

AI-generated analysis. Not financial advice.

• Precigen transitioned to a commercial stage company with the US approval of PAPZIMEOS in August 2025, the first-and-only FDA-approved treatment for adults with RRP
• PAPZIMEOS commercialization is well underway and PAPZIMEOS is being prescribed nationwide, with patients actively receiving treatment
• PAPZIMEOS patient hub enrollment has surpassed 200 registered patients, doubling since November, and reflecting significant demand at both major medical centers and community practices
• Patient access continues to expand, with private health plan coverage now at approximately 170 million US lives, including the majority of leading insurers. PAPZIMEOS is also covered under Medicare and Medicaid
• The European Medicines Agency has validated the Marketing Authorization Application for PAPZIMEOS for the treatment of adults with RRP
• The Company continues to expect current capital resources to fund operations through cash flow break-even

GERMANTOWN, Md., Jan. 12, 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 provided an update on the rapid commercialization momentum and growing market adoption of PAPZIMEOS^TM (zopapogene imadenovec-drba), the first-and-only US Food and Drug Administration (FDA)-approved therapy for recurrent respiratory papillomatosis (RRP). Precigen's company presentation at the 44th Annual J.P. Morgan Healthcare Conference will be on January 15, 2026 at 7:30 AM PT.

"Commercialization of PAPZIMEOS is proceeding as planned following FDA approval, with rapid and broad adoption supported by compelling safety, efficacy, and long-term durability data, expanding payer access, and strong engagement across major medical centers and community practices nationwide," said Helen Sabzevari, PhD, President and CEO of Precigen. "We are seeing tremendous enthusiasm from physicians across the country who are eager to bring this therapy to their patients. Importantly, we are moving rapidly to make PAPZIMEOS available globally, highlighted by the European Medicines Agency validation of the Marketing Authorization Application. As the first-and-only FDA-approved therapy for adults with RRP, PAPZIMEOS is redefining the treatment paradigm, and the momentum we are seeing underscores its impact and value as we advance toward anticipated cash-flow break-even and global expansion."

"Our commercial launch continues to build strong momentum, with patient hub enrollment doubling since November, expanding commercial health plan coverage alongside Medicare and Medicaid, and near-complete field engagement across target centers," said Phil Tennant, Chief Commercial Officer of Precigen. "Manufacturing and supply chain capabilities are fully in place to meet current demand and anticipated growth, and patients are now receiving PAPZIMEOS nationwide. Importantly, PAPZIMEOS remains the only FDA-approved therapy for adults with RRP, providing an exclusive window to execute our commercial strategy. Based on these dynamics, we expect adoption to continue accelerating as PAPZIMEOS becomes established as the preferred first-line treatment and new standard of care."

PAPZIMEOS: Establishing a New Standard of Care for the Treatment of Adults with RRP

• PAPZIMEOS full approval with broad label: In August 2025, the FDA granted full approval of PAPZIMEOS with a broad label and no requirement for a confirmatory trial for the treatment of adults with RRP.
• PAPZIMEOS prescribing, treatment, and distribution: PAPZIMEOS is being prescribed nationwide, with patients actively receiving treatment. PAPZIMEOS is currently shipping to prescribers across the US, supported by established cold-chain logistics and coordinated solutions to address site-level needs.
• Rapid commercialization: Rapid commercial launch execution is underway with over 96% of target centers engaged since full deployment of the sales team in September. To date, more than 200 patients have been registered in the PAPZIMEOS patient hub, doubling since November. In addition to these registered patients, a significant number of patients have been identified outside of the PAPZIMEOS hub through the Company's field engagement efforts.
• Positive payer coverage: Private health plan coverage is progressing rapidly with approximately 170 million lives covered to date, including the majority of leading insurers. PAPZIMEOS is also covered under Medicare and Medicaid.
• Compelling long-term clinical and real-world evidence published: At AAO-HNSF 2025 and SITC 2025, the Company reported long-term durable complete responses with PAPZIMEOS, and at ISPOR Europe 2025, the Company published data demonstrating the substantial healthcare resource utilization and patient-reported quality-of-life burden of RRP, underscoring the disease's significant clinical, economic, and human impact.
• EMA validation complete: Following a submission in November 2025, the European Medicines Agency has validated the Marketing Authorization Application for PAPZIMEOS for the treatment of adults with RRP.

About RRP
RRP is a rare, debilitating, and potentially life-threatening disease of the upper and lower respiratory tract caused by chronic HPV 6 or HPV 11 infection. RRP can lead to severe voice disturbance, compromised airways, and recurrent post-obstructive pneumonia. Although rare, RRP has the potential for transformation to malignant cancer and can be fatal. Management of RRP has primarily consisted of repeated surgeries, which do not address the underlying cause of the disease and can be associated with significant morbidity as well as significant patient and health system burden. As the number of lifetime surgeries increases, the risk for irreversible iatrogenic laryngeal injury increases with each surgery, and patients may undergo hundreds of these surgeries over their lifetimes. RRP can impact patients' work and social lives, financial stability, and mental health. Patients with RRP can experience substantial impacts to daily living with decreased quality of life and high health care utilization. Based on an internal analysis of claims data and electronic health records, there are approximately 27,000 adult RRP patients in the US.

About PAPZIMEOS (zopapogene imadenovec-drba), for subcutaneous injection only
PAPZIMEOS is the first-and-only FDA-approved therapy for the treatment of adults with RRP and the first-and-only approved therapy to address the root cause of RRP. PAPZIMEOS is a non-replicating adenoviral vector-based immunotherapy designed to express a fusion antigen comprising selected regions of human papillomavirus (HPV) types 6 and 11 proteins. PAPZIMEOS is designed to generate an immune response directed against HPV 6 and HPV 11 proteins in patients with RRP. Discovered and designed in Precigen's labs using Precigen's proprietary AdenoVerse therapeutic platform, PAPZIMEOS represents a new therapeutic paradigm for RRP. Full prescribing information can be found at www.precigen.com/papzimeos-prescribing-information.pdf.

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, 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

What did Precigen (PGEN) announce about PAPZIMEOS at J.P. Morgan on January 15, 2026?

Precigen said PAPZIMEOS commercial launch is underway with broad adoption, payer coverage for ~170 million US lives, >200 patient-hub registrations, and EMA MAA validation.

When did PAPZIMEOS receive full FDA approval and what does that mean for PGEN?

PAPZIMEOS received full FDA approval in August 2025 with a broad label and no confirmatory trial required, enabling commercial availability nationwide.

How many patients have been registered for PAPZIMEOS and how fast is enrollment growing?

The PAPZIMEOS patient hub has registered >200 patients, a figure that doubled since November 2025.

What payer coverage does PAPZIMEOS have for US patients as of January 12, 2026?

PAPZIMEOS has private health plan coverage for approximately 170 million US lives and is covered under Medicare and Medicaid.

Has Precigen taken steps toward international availability for PAPZIMEOS?

Yes; the European Medicines Agency validated the Marketing Authorization Application for PAPZIMEOS after a November 2025 submission.

Can Precigen fund operations while scaling PAPZIMEOS commercial activities?

The company expects current capital resources to fund operations through anticipated cash-flow break-even (no specific date provided).