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Precigen Reports Full Year 2025 Financial Results and Business Updates

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 PAPZIMEOS generated $3.4 million in net product revenue in the fourth quarter of 2025, reflecting the first partial quarter of US commercial sales as payer policies came into effect; the US launch continues to build strong momentum, with a significant increase in demand in the first quarter of 2026 The Centers for Medicare and Medicaid Services has assigned a permanent J-code, J3404, to PAPZIMEOS, effective April 1, 2026, streamlining the claims process and facilitating broader patient access Marketing Authorization Application for PAPZIMEOS for the treatment of adults with RRP validated by the European Medicines Agency and is under review Open-label redosing study initiated to evaluate retreatment efficacy of zopapogene imadenovec in adults with RRP Expert consensus paper sponsored and published by the Recurrent Respiratory Papillomatosis Foundation and authored by 16 leading physicians in the field of RRP recommended PAPZIMEOS as the new standard of care first-line treatment for adults with RRP in the US Cash, cash equivalents, and investments totaled $100.4 million as of December 31, 2025, which is expected to fund the Company's operations to cash flow break-even Conference call scheduled for 4:30 PM ET today to discuss full year 2025 financial results and provide further substantive updates on commercial progress for the first quarter of 2026 GERMANTOWN, Md., March 25, 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 full year 2025 financial results and business updates.

New Expert Consensus Published in The Laryngoscope Recommends PAPZIMEOS (zopapogene imadenovec) as the New Standard of Care First-Line Treatment for Adults with Recurrent Respiratory Papillomatosis

Independent, expert-led consensus paper, sponsored by the Recurrent Respiratory Papillomatosis Foundation, reflects the recommendation of 16 leading physicians in the field of RRP Consensus paper recommends PAPZIMEOS as the new standard of care  first-line treatment for adults with RRP GERMANTOWN, Md., Jan. 20, 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 the publication of a new expert consensus paper sponsored by the Recurrent Respiratory Papillomatosis Foundation (RRPF) and authored by 16 leading physicians in the field of recurrent respiratory papillomatosis (RRP) has been published in The Laryngoscope, one of the field's most respected peer-reviewed journals.

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

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.

Precigen Reports Third Quarter 2025 Financial Results and Business Updates

PAPZIMEOS (zopapogene imadenovec-drba) received full approval by the FDA in August PAPZIMEOS launched with a broad label in the US as the first and only FDA-approved treatment for adults with RRP PAPZIMEOS is now available and shipping to prescribers in the US for the treatment of adults with RRP To date, over 100 patients have been registered in the PAPZIMEOS Patient Hub The Company has made significant progress with private health insurance coverage, with more than 100 million lives covered to date; PAPZIMEOS is now available through Medicare and Medicaid Rapid commercial launch execution underway with full deployment of the sales team in September and over 90% of target institutions engaged In October, the Company announced long-term follow-up results from the PAPZIMEOS pivotal clinical trial highlighting ongoing durable (median 36 months) complete responses without any additional treatment interventions In November, the Company submitted a Marketing Authorization Application to the European Medicines Agency for zopapogene imadenovec for the treatment of adults with RRP Cash, cash equivalents, and investments totaled $123.6 million as of September 30, 2025, which is expected to fund the Company's operations to cash flow break-even GERMANTOWN, Md. , Nov. 13, 2025 /PRNewswire/ -- Precigen, Inc. (Nasdaq: PGEN), a biopharmaceutical company specializing in the advancement of innovative precision medicines to improve the lives of patients, today announced third quarter 2025 financial results and business updates.