FDA orphan drug designation grants Precigen market protection for PAPZIMEOS through August 2032, bolstering revenue potential.
Precigen (NASDAQ:PGEN) secured FDA orphan drug exclusivity for PAPZIMEOS, a treatment for adult recurrent respiratory papillomatosis (RRP). The designation blocks competing therapies for seven years, extending market exclusivity until August 2032.
PAPZIMEOS, developed using Precigen’s AdenoVerse platform, targets HPV 6 and 11, the primary causes of RRP. Clinical data from the 2026 ASCO Annual Meeting showed 83% of complete responders remained surgery-free for at least 36 months, with five patients requiring no further interventions beyond four years.
The treatment is commercially available across the U.S. and reduces the need for frequent surgeries to remove benign respiratory tumors. Precigen is a commercial-stage biopharmaceutical company focused on gene and cell therapies.