Precigen’s PAPZIMEOS Receives Full FDA Approval as First Therapy for Adults with Recurrent Respiratory Papillomatosis

Reuters
2025.10.13 11:01
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Precigen Inc. announced that PAPZIMEOS™ (zopapogene imadenovec-drba) received full FDA approval in August 2025 as the first therapy for adults with recurrent respiratory papillomatosis (RRP). The approval is based on pivotal study results showing durable responses and reduced surgery needs among patients, with no new safety events reported during long-term follow-up. This marks a significant milestone for treatment options in RRP.

Precigen Inc. has announced that PAPZIMEOS™ (zopapogene imadenovec-drba) received full approval from the United States Food and Drug Administration (FDA) in August 2025 for the treatment of adults with recurrent respiratory papillomatosis (RRP). This marks PAPZIMEOS as the first and only FDA-approved therapy for adults with RRP. The approval was supported by pivotal study results demonstrating durable responses and a significant reduction in the need for surgeries among treated patients. No new safety events were observed during long-term follow-up. There is no indication that this approval or related funding involved multiple organizations. Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Precigen Inc. published the original content used to generate this news brief via PR Newswire (Ref. ID: NY95670) on October 13, 2025, and is solely responsible for the information contained therein. © Copyright 2025 - Public Technologies (PUBT)