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GERMANTOWN, Md. - Precigen, Inc. (NASDAQ:PGEN) announced Monday that 83% of complete responders continue to show durable responses to PAPZIMEOS (zopapogene imadenovec-drba) treatment for recurrent respiratory papillomatosis (RRP) after a median follow-up of 36 months. The company, currently valued at $930 million, has seen its stock surge over 240% in the past year, according to InvestingPro data.
According to data presented at the American Academy of Otolaryngology-Head and Neck Surgery Foundation Annual Meeting, 15 out of 18 complete responders from the pivotal study maintained their response status, with the median duration of complete response not yet reached.
The data also showed a progressive reduction in surgical interventions compared to pre-treatment levels, with 86% of patients requiring fewer surgeries in Year 1, 91% in Year 2, and 95% in Year 3. No new safety events were observed during the long-term follow-up period.
PAPZIMEOS received full FDA approval in August 2025 as the first therapy authorized for treating adults with RRP, a rare and potentially life-threatening disease of the respiratory tract caused by HPV 6 or 11 infection. The condition typically requires repeated surgeries that can lead to voice disturbance, compromised airways, and potential malignant transformation.
The therapy is designed as a non-replicating adenoviral vector-based immunotherapy that generates an immune response against HPV 6 and 11 proteins. In the pivotal study, 51% of patients achieved complete response, defined as requiring no surgeries in the 12-month period following treatment.
Common side effects reported include injection site reactions, fatigue, chills, fever, muscle aches, and nausea.
The information in this article is based on a press release statement from Precigen. For comprehensive analysis of Precigen’s financial health, growth prospects, and 12 additional exclusive ProTips, visit InvestingPro, where you’ll find detailed research reports and expert insights.
In other recent news, Precigen, Inc. reported the conversion of 79,000 shares of its Series A Convertible Perpetual Preferred Stock into approximately 54.9 million common shares. This corporate action, valued at $79 million, was executed without the need for registration under the Securities Act of 1933. Additionally, Precigen has secured $100 million in non-dilutive financing through a credit facility agreement with Pharmakon Advisors, LP, with the potential to access an additional $25 million by 2027. This financing bears interest at a variable rate of 6.50% plus a three-month SOFR with a 3.75% floor.
Cantor Fitzgerald has reiterated its Overweight rating on Precigen, reflecting a positive outlook despite recent stock volatility. Furthermore, H.C. Wainwright has maintained a Buy rating and set a price target of $8.50 following the FDA’s early approval of Papzimeos for treating recurrent respiratory papillomatosis. The wholesale acquisition cost for the treatment is set at $460,000 for a 12-week course. These developments highlight significant financial and regulatory milestones for Precigen.
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