FDA Grants Platform Designation to Precigen's AdenoVerse Tech
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Germantown, Md. – September 21, 2026 -- The U.S. Food and Drug Administration has granted platform technology designation to Precigen's AdenoVerse immunotherapeutic platform, the technology underlying the company's first commercial product, PAPZIMEOS, approved in August 2025 for recurrent respiratory papillomatosis (RRP) in adults.
FDA designation opens accelerated pathway for future AdenoVerse cancer programs
The designation allows Precigen to leverage manufacturing and preclinical data generated for PAPZIMEOS to support future marketing applications for other AdenoVerse-based candidates, reducing duplicative development work. It also grants the company earlier and more frequent FDA engagement and allows regulators to consider prior manufacturing inspections when reviewing future applications.