PRECIGEN, INC.
PGEN evidence brief
What we can confirm
- BioSniper Score:
- 6.0 / 10
- Market Cap:
- $2.45B
- Lead Asset:
- papzimeos (Approved)
What it means
What to watch
Prepared research question
What matters most for PGEN—catalysts, financial risk and supporting evidence?
Traceable citations · Unknowns marked
BioSniper AI · PGEN
Precigen, Inc. (PGEN) is a commercial-stage biotechnology company focused on the development and commercialization of therapies for immuno-oncology, autoimmune disorders, and infectious diseases, anchored by its first FDA-approved product, Papzimeos, for recurrent respiratory papillomatosis.
Key risk: Single-product concentration
BioSniper Score
Based on 4 of 6 signals
Market Cap
$2.45B
Cash Runway
—
Lead Asset
papzimeos (Approved)
Next Catalyst
—
Financial data as of Jun 30, 2026.
Tracking 6 pipeline candidates · 4 clinical trials for PRECIGEN, INC..
Precigen, Inc. (PGEN) is a commercial-stage biotechnology company focused on the development and commercialization of therapies for immuno-oncology, autoimmune disorders, and infectious diseases, anchored by its first FDA-approved product, Papzimeos, for recurrent respiratory papillomatosis.
- Papzimeos (zopapogene imadenovec-drba) is the first-and-only FDA-approved treatment for adults with recurrent respiratory papillomatosis (RRP), approved in August 2025 [news · published 2026-03-25].
- As of 2026-06-30, the company reported cash & equivalents of $16.3M, total revenue of $55.0M, net income of $20.1M, shareholders' equity of $43.6M, and total debt of $100.0M [sec].
- Precigen has completed a Phase 1b/2a clinical trial of AG019, an ActoBiotic for type 1 diabetes, and has shut down ActoBio's operations, making its intellectual property available for transactions [sec_mda · as of 2026-05-13].
- The company's UltraCAR-T platform includes PRGN-3005 (Phase 1/1b for ovarian cancer) and PRGN-3006 (Phase 1b for AML), with completed dose escalation portions [sec_mda · as of 2026-08-04].
- A Marketing Authorisation Application (MAA) for Papzimeos has been submitted to the European Medicines Agency [sec · filed 2026-04-30].
What works
- Papzimeos is the first FDA-approved treatment for RRP, with 83% of complete responders showing ongoing complete responses at a median follow-up of 36 months as of September 2025 [sec · filed 2026-04-30].
- The company's cGMP manufacturing facility for Papzimeos drug substance passed a successful FDA pre-approval inspection (PAI) in 2025 [sec · filed 2026-04-30].
- Precigen has a diversified pipeline including UltraCAR-T programs (PRGN-3005, PRGN-3006) and a Phase 2 study of PRGN-2009 in cervical cancer [sec_mda · as of 2026-08-04][catalyst].
What to weigh
- Precigen is heavily reliant on a single commercial product, Papzimeos, creating concentration risk; its broader development portfolio is needed to diversify future revenue [news · published 2026-08-28].
- The company faces risks typical of first-product launches, including uncertain market demand, dependence on key individuals and IP, and competition [sec_mda · as of 2026-08-04].
- Precigen has significant debt of $100.0M as of 2026-06-30, which may pressure financial flexibility [sec].
- The ActoBio subsidiary was shut down in 2024, and its lead asset AG019 (Phase 1b/2a for T1D) has no clear path forward, with IP now available for transactions [sec_mda · as of 2026-05-13].
From the filings
Quoted directly from source documents.
Papzimeos is the first FDA-approved treatment for RRP
“Precigen transitioned to a commercial stage company with the US approval of PAPZIMEOS™ (zopapogene imadenovec-drba), the first-and-only FDA-approved treatment for adults with RRP, in August 2025”
News · March 25, 2026
83% of complete responders had ongoing complete responses at 36 months median follow-up
“83% of complete responders in the pivotal study demonstrated ongoing complete responses with median follow up of 36 months as of September 19, 2025 date cut-off”
SEC filings · April 30, 2026
ActoBio operations were shut down in 2024
“In 2024, the Company completed the shutdown of ActoBio's operations.”
SEC MD&A · May 13, 2026
Catalyst timeline
- 2021-03-16 · Phase 1/2 Study of Adjuvant PRGN-2012 in Adult Patients With Recurrent Respiratory Papillomatosis — This study supported the approval of Papzimeos; no further catalysts listed for this program.
- 2023-01-25 · Phase 1/1b Dose Escalation/Dose Expansion Study of PRGN-3007 UltraCAR-T Cells — Early-stage trial for advanced hematologic and solid tumor malignancies; no update on next steps.
- 2024-12-30 · AdCom: PRGN-2012 — Advisory Committee meeting for PRGN-2012 (Papzimeos) preceded FDA approval in 2025.
- 2025-03-21 · Phase 2 Study of PRGN-2009 in Combination With Pembrolizumab Versus Pembrolizumab Monotherapy in Recurrent or Metastatic Cervical Cancer — This randomized Phase 2 trial is ongoing; results will inform the program's viability.
Risks & what to watch (4)›
Key risks
- Single-product concentration — Papzimeos is the only marketed drug; reliance on one product heightens revenue risk [news · published 2026-08-28].
- High debt burden — Total debt of $100.0M as of 2026-06-30 may constrain capital for R&D and operations [sec].
- Pipeline uncertainty — Early-stage UltraCAR-T programs (PRGN-3005, PRGN-3006) are in Phase 1/1b; no approved follow-on products [sec_mda · as of 2026-08-04].
- ActoBio shutdown — ActoBio subsidiary closed in 2024; lead T1D asset AG019 has no ongoing development [sec_mda · as of 2026-05-13].
What to watch
- Commercial ramp of Papzimeos in the US and potential EU approval following MAA submission [sec · filed 2026-04-30].
- Progress of UltraCAR-T programs PRGN-3005 (ovarian cancer) and PRGN-3006 (AML) as they advance beyond Phase 1 [sec_mda · as of 2026-08-04].
- Outcome of the Phase 2 study of PRGN-2009 in cervical cancer (started 2025-03-21) [catalyst].
- Ability to manage $100.0M debt and generate sufficient cash flow from Papzimeos to fund ongoing R&D [sec].
Sources: Catalysts · News · SEC filings · SEC MD&A · Generated October 10, 2026 · How we verify sources →
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Evidence & data
Score breakdownBased on 4 of 6 signals · derived from public data
Cash runway data unavailable
D/E 2.91 · 16% dilution
Lead: Approved
6 candidates
No upcoming catalysts tracked
1 buy · 16 sells (180d)
Pipeline
Regulatory
Financials
Institutional Holdings
Source: SEC Form 13F · as of Mar 2026Institutional holders
205
Total value held
$511.5M
| Holder | Shares | Value |
|---|---|---|
| patient capital management, llc | 17,817,387 | $69.0M |
| blackrock, inc. | 15,223,191 | $58.9M |
| state street corp | 10,890,124 | $42.1M |
| vanguard capital management llc | 7,148,996 | $27.7M |
| diametric capital, lp | 6,801,788 | $26.3M |
| point72 asset management, l.p. | 6,644,361 | $25.7M |
| tang capital management llc | 6,417,500 | $24.8M |
| geode capital management, llc | 4,613,429 | $17.9M |
| occam crest management lp | 4,269,051 | $16.5M |
| iridian asset management llc/ct | 3,592,730 | $13.9M |
Showing top 10 of 205 institutional holders of PRECIGEN, INC.. Open the full 13F history after sign-in.
Short Interest
as of Apr 19, 2026- % of float
- 17.3%
- Days to cover
- 7.0
- Shares short
- 39,661,787
- Daily short volume
- -
Short percent of float and days-to-cover reflect reported short positioning. Daily short volume is the exchange-reported short share of a single day's trading volume and is noisier. See the most-shorted biotech ranking →
PGEN short interestGovernance
Frequently asked questions
What is the AI investment thesis for PRECIGEN, INC.?
Precigen, Inc. (PGEN) is a commercial-stage biotechnology company focused on the development and commercialization of therapies for immuno-oncology, autoimmune disorders, and infectious diseases, anchored by its first FDA-approved product, Papzimeos, for recurrent respiratory papillomatosis.
What is PRECIGEN, INC.'s lead drug candidate?
PRECIGEN, INC.'s most advanced tracked candidate is papzimeos (Approved) for treatment of adults with recurrent respiratory papillomatosis (RRP).
Who is the CEO of PRECIGEN, INC.?
Dr. Helen Sabzevari MPH, Ph.D. is the chief executive officer of PRECIGEN, INC. (PGEN).
Where is PRECIGEN, INC. headquartered?
PRECIGEN, INC. (PGEN) is headquartered in Germantown, MD, United States.
What therapeutic areas does PRECIGEN, INC. focus on?
PRECIGEN, INC. develops therapies across Oncology, Gene Therapy, Respiratory.
The AI overview and BioSniper Score are neutral, data-derived signals built from public SEC filings, ClinicalTrials.gov and FDA records — not investment advice.