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. reports developments as a commercial-stage biopharmaceutical company advancing precision medicines for difficult-to-treat diseases. Its news centers on PAPZIMEOS (zopapogene imadenovec-drba), an FDA-approved therapy for adults with recurrent respiratory papillomatosis, including commercialization, access, reimbursement, medical-publication updates, and adoption by treating physicians.
Company updates also cover financial results, business presentations, and pipeline activity across immuno-oncology, autoimmune disorders, and infectious diseases. Precigen’s recurring technology references include the AdenoVerse immunotherapy platform, UltraCAR-T programs, and related manufacturing capabilities used to support its precision-medicine portfolio.
Precigen (Nasdaq:PGEN) announced that the FDA has granted orphan drug exclusivity for PAPZIMEOS (zopapogene imadenovec-drba) to treat adults with recurrent respiratory papillomatosis (RRP). PAPZIMEOS, fully approved in August 2025, is the first and only FDA-approved RRP therapy and is commercially available nationwide.
The orphan exclusivity runs through August 14, 2032, providing seven years of US market exclusivity from approval. According to Precigen, this exclusivity, combined with its PAPZIMEOS patent portfolio, strengthens market protection and supports long-term revenue potential.
Precigen (Nasdaq:PGEN) will participate in two upcoming investor events. A J.P. Morgan virtual fireside chat is scheduled for June 1, 2026 at 10:00 a.m. ET, featuring CEO Helen Sabzevari and Chief Commercial Officer Phil Tennant.
At the Goldman Sachs 47th Annual Global Healthcare Conference in Miami Beach from June 8–10, 2026, Helen Sabzevari will join a fireside chat on June 8 at 9:20 a.m. ET. Event details are available in the Events & Presentations section of Precigen's investor website.
Precigen (Nasdaq:PGEN) reported first quarter 2026 results driven by the US launch of PAPZIMEOS, generating $21.6 million in net product revenue. Total revenue rose $21.9 million year-over-year, while net loss narrowed to $7.9 million.
Cash, cash equivalents, and investments were $56.7 million at March 31, 2026, excluding about $25.7 million of PAPZIMEOS receivables. According to Precigen, these resources and expected PAPZIMEOS revenue are projected to fund operations to cash flow break-even by end of 2026. PAPZIMEOS has roughly 400 hub-enrolled patients, payer coverage for about 297 million US lives, a permanent J-code effective April 1, 2026, and an EMA marketing application under review. The company continues Phase 2 trials of PRGN-2009 in HPV-associated cancers and plans an AdenoVerse pipeline update by year-end.
Precigen (Nasdaq: PGEN) will release first quarter 2026 financial results and provide business updates on May 13, 2026. A conference call is scheduled the same day at 4:30 PM ET; dial-in details and event materials are available in the company’s Events & Presentations section.
Investors are asked to call 10–15 minutes early to ensure timely connection.
Precigen (NASDAQ: PGEN) reported robust uptake of PAPZIMEOS (zopapogene imadenovec-drba) after its August 2025 approval. CMS assigned J-code J3404 effective April 1, 2026. Net product sales were $3.4M in Q4 2025, patient hub enrollment topped 300, and Q1 2026 revenue is expected to exceed $18M. The company filed with the EMA (validated) and plans a pediatric trial in Q4 2026 and a patient redosing study.
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.