Welcome to our dedicated page for Precigen news (Ticker: PGEN), a resource for investors and traders seeking the latest updates and insights on Precigen stock.
Precigen, Inc. (Nasdaq: PGEN) is a biopharmaceutical company focused on precision medicines, and its news flow reflects the transition from a clinical-stage organization to a commercial-stage company. Recent announcements highlight full FDA approval and commercial launch of PAPZIMEOS (zopapogene imadenovec-drba), which the company describes as the first and only FDA-approved therapy for adults with recurrent respiratory papillomatosis (RRP). News items detail how PAPZIMEOS was discovered and designed using Precigen’s AdenoVerse platform and how it is being prescribed nationwide in the United States.
Investors and observers following PGEN news will see updates on PAPZIMEOS commercialization, including patient hub enrollment, payer coverage across private health plans and government programs, manufacturing and supply chain arrangements, and engagement with major medical centers and community practices. The company also issues news on long-term clinical data for PAPZIMEOS, emphasizing durable complete responses, reductions in surgery rates, and safety outcomes presented at medical meetings and in peer-reviewed publications.
Beyond PAPZIMEOS, Precigen’s news coverage includes pipeline developments such as progress in Phase 2 trials for PRGN-2009 in HPV-associated cancers and updates on PRGN-3006, an investigational UltraCAR-T therapy for acute myeloid leukemia and myelodysplastic syndromes. Financial results releases and related press statements provide context on capital resources, non-dilutive financing arrangements, preferred stock transactions, and the company’s expectations regarding funding operations through a projected cash flow break-even point.
Visitors to the PGEN news page can expect regular disclosures on regulatory milestones, conference presentations, investor webcasts, and business updates that illustrate how Precigen is advancing its precision medicine strategy and commercial execution around PAPZIMEOS and its broader pipeline.
Precigen (Nasdaq: PGEN) announced a virtual fireside chat with H.C. Wainwright on March 31, 2026 from 11:00 AM to 12:00 PM ET. Helen Sabzevari, PhD, President and CEO, and Phil Tennant, Chief Commercial Officer, will participate.
Participants can view event details and access the webcast via Precigen's Events & Presentations page at investors.precigen.com/events-presentations.
Precigen (Nasdaq: PGEN) reported full-year 2025 results after transitioning to a commercial-stage company with FDA approval of PAPZIMEOS in August 2025. PAPZIMEOS generated $3.4M in 2025 product revenue and patient hub enrollment surpassed 300. Cash, cash equivalents, and investments totaled $100.4M at December 31, 2025, and management expects funds to support operations to cash-flow break-even by end of 2026. The EMA validated the PAPZIMEOS MAA for review, and CMS assigned permanent J-code J3404 effective April 1, 2026, to streamline reimbursement and broaden access.
Precigen (Nasdaq: PGEN) will release full year 2025 financial results and provide business updates on Wednesday, March 25, 2026. A conference call to discuss results is scheduled for 4:30 PM ET.
Dial-in details include 1-800-836-8184 (North America) and 1-646-357-8785 (International). Event details are available in the Events & Presentations section at the company website.
Precigen (Nasdaq: PGEN) announced publication of an independent expert consensus paper in The Laryngoscope (Jan 20, 2026) recommending PAPZIMEOS (zopapogene imadenovec) as the new standard of care first-line treatment for adults with recurrent respiratory papillomatosis (RRP).
The consensus, authored by 16 RRP specialists and sponsored by the Recurrent Respiratory Papillomatosis Foundation, prioritizes HPV-specific immunotherapy over repeated surgery, cites demonstrated safety and long-term durability in responders, and promotes early therapy, shared decision-making, and multidisciplinary care. The full position statement is available online in The Laryngoscope.
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.
Precigen (Nasdaq: PGEN) announced that Helen Sabzevari, PhD, President and CEO, will present at the 44th Annual J.P. Morgan Healthcare Conference in San Francisco on January 15, 2026 at 7:30 AM PT. Dr. Sabzevari will also join a fireside chat hosted by commercialization partner Eversana on January 12, 2026 at 10:30 AM PT during the Biotech Showcase (January 12–14, 2026).
Investors and other participants may view event details in the company’s Events & Presentations section at the investor website.
Precigen (Nasdaq: PGEN) reported Q3 2025 results and business updates after FDA full approval of PAPZIMEOS in August 2025 for adults with recurrent respiratory papillomatosis (RRP). PAPZIMEOS is commercially available and shipping in the US with >100 patients registered in the PAPZIMEOS Patient Hub and >90% of target institutions engaged since sales deployment in September 2025.
Long-term follow-up (data cutoff Sept 19, 2025) showed durable complete responses in 15 of 18 patients (83%) with median follow-up of 36 months. Cash, cash equivalents, and investments were $123.6M as of Sept 30, 2025; company also accessed a credit facility providing up to $125M and received a $100M tranche.
Precigen (Nasdaq: PGEN) will release third quarter 2025 financial results and provide business updates on November 13, 2025. The company will host a conference call at 4:30 PM ET the same day; dial-in numbers are 1-800-836-8184 (North America) and 1-646-357-8785 (International). Participants are asked to call 10–15 minutes early. Event details and a webcast are available in the Events & Presentations section at investors.precigen.com/events-presentations. The release includes a standard cautionary statement about forward-looking statements, including references to PAPZIMEOS and regulatory and clinical risks.
Precigen (Nasdaq: PGEN) reported long-term follow-up showing durable clinical benefit after treatment with PAPZIMEOS for adults with recurrent respiratory papillomatosis (RRP). PAPZIMEOS received full FDA approval in August 2025 as the first and only approved therapy for adults with RRP. In the pivotal study 51% (18/35) of patients achieved complete response in the first 12 months (95% CI: 34-69%). As of the September 19, 2025 cutoff, 15 of 18 complete responders (83%) remained in ongoing complete response with a median follow-up of 36 months (range 27–37); median duration of complete response not yet reached. Surgical interventions decreased versus the year prior in 86% (Year 1), 91% (Year 2) and 95% (Year 3). No new safety events observed during long-term follow-up.
Precigen (Nasdaq: PGEN) has secured a significant non-dilutive credit facility of up to $125 million through Pharmakon Advisors, LP. The financing includes $100 million funded at closing and an additional $25 million available through March 31, 2027. The credit facility matures in five years and carries an interest rate of 6.50% plus three-month SOFR with a 3.75% floor.
The funding will support the US commercialization of PAPZIMEOS, Precigen's novel immunotherapy for recurrent respiratory papillomatosis (RRP) in adults. The company plans to use the proceeds for international market expansion and pursuing pediatric and other HPV-related indications. This strategic financing positions Precigen for its transition into a commercial-stage biopharmaceutical company.