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PGEN 资讯
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Precigen Receives FDA Designation for AdenoVerse Platform Technology
Precigen announced that the United States FDA granted platform technology designation to the AdenoVerse immunotherapeutic platform, which is used in the company's first commercial product, Papzimeos. The designation reflects the adaptability and potential of the platform to address a broad range of indications, including HPV-positive malignancies such as head and neck, cervical, anal, vulvar and vaginal cancers, as well as other diseases that may be targeted by future AdenoVerse-based product candidates.
Precigen Reports $53.1M Net Revenue in Q2
For Precigen, the second quarter marked a commercial inflection. PAPZIMEOS generated $53.1 M in net product revenue-more than double the prior quarter-and helped the company achieve quarterly profitability. President and CEO Helen Sabzevari, PhD, framed the quarter as platform validation. "PAPZIMEOS demonstrates the AdenoVerse platform's ability to target HPV-associated diseases. We are building on that validated capability by advancing PRGN-2009 in HPV-driven cancers," she said.
Precigen Reports Q2 Revenue of $55.0M, Exceeding Expectations
Reports Q2 revenue $55.0M, consensus $27.83M. "We delivered a historic Q2, with the rapid adoption of PAPZIMEOS demonstrating the strength of our groundbreaking science and innovative commercial strategy," said Helen Sabzevari, President and CEO of Precigen. "This momentum provides a strong foundation for our next phase of growth as we work to expand PAPZIMEOS globally and into the pediatric population. PAPZIMEOS demonstrates the AdenoVerse platform's ability to target HPV-associated diseases. We are building on that validated capability by advancing PRGN-2009 in HPV-driven cancers, with a pipeline update expected by year-end. With growing commercial momentum, a validated platform, and multiple opportunities ahead, we believe Precigen is well positioned to deliver sustained value for patients across various indications, the broader healthcare community, and our shareholders."
Precigen Updates Papzimeos Study Data
Precigen announced updated long-term follow-up data from the study of Papzimeos for the treatment of adults with recurrent respiratory papillomatosis, RRP. Updated durability of response data were presented at the 2026 American Society of Clinical Oncology, ASCO, Annual Meeting in Chicago in a presentation titled, "Zopapogene imadenovec-drba, a novel non-replicating adenoviral vector-based immunotherapy: Effects on complete and durable responses in recurrent respiratory papillomatosis pivotal trial." Key data highlights from the ASCO presentation include: 15 out of 18 complete responders, or 83%, demonstrated ongoing complete responses as of the April 30, 2026 data cutoff; Patients did not receive any additional treatments for RRP; All complete responders had at least 36 months of follow-up, with a median follow-up of 36 months and a mean follow-up of 40 months; 5 complete responders have ongoing responses beyond 4 years; Median duration of complete response has not yet been reached; and No new safety events were observed during long-term follow-up.
Precigen Receives FDA Orphan Drug Exclusivity for Papzimeos
Precigen announced that the FDA has granted orphan drug exclusivity for papzimeos - zopapogene imadenovec-drba - for the treatment of adults with recurrent respiratory papillomatosis, or RRP. Papzimeos was granted full approval by the FDA in August 2025, becoming the first and only approved treatment for adults with RRP, a rare, chronic and debilitating disease. Papzimeos is commercially available in the US and is being prescribed nationwide across both major medical centers and community practices. Orphan drug exclusivity is granted to certain drugs and biologics approved for rare diseases or conditions that affect fewer than 200,000 people in the U.S. The orphan drug exclusivity granted by the FDA for papzimeos for the treatment of adults with RRP is effective through August 14, 2032, providing seven years of market exclusivity in the U.S. RRP is a rare, debilitating, and potentially life-threatening disease of the upper and lower respiratory tract that can lead to severe voice disturbance, compromised airways, and recurrent post-obstructive pneumonia.
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