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 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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