09:56 AM EST, 02/25/2025 (MT Newswires) -- Precigen ( PGEN ) said Tuesday that a biologics license application for PRGN-2012, an investigational gene therapy for the treatment of adults with recurrent respiratory papillomatosis, was accepted by the US Food and Drug Administration for priority review.

The agency set a target action date of Aug. 27 and said that it is not planning to hold an advisory committee meeting to discuss the application.

PRGN-2012 is designed to elicit immune responses directed against cells infected with human papillomavirus 6 or HPV 11, the company said.

The application is supported by data from a clinical study that met its primary safety and efficacy endpoints, Precigen ( PGEN ) said. The study showed more than 50% of patients achieving complete response and more than 85% of patients experiencing a decrease in surgical interventions in the year after treatment compared to the year prior to treatment.

PGEN shares were over 2% higher in recent trading.

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