Precigen (PGEN) Secures FDA Orphan Drug Exclusivity for PAPZIMEOS

Precigen (PGEN) Secures FDA Orphan Drug Exclusivity for PAPZIMEOS Maham Fatima Sun, June 21, 2026 at 12:28 AM GMT+7 1 min read PGEN Precigen Inc. (NASDAQ:PGEN) is one of the penny stocks with explosive growth potential. On June 15, Precigen secured FDA orphan drug exclusivity for PAPZIMEOS, a precision medicine treating adult recurrent respiratory papillomatosis/RRP. This regulatory designation prevents the FDA from approving similar treatments for 7 years, extending the drug’s market exclusivity and protecting its revenue potential through August 2032. Developed using Precigen’s AdenoVerse platform, PAPZIMEOS uses a modified adenovirus to train the immune system to target HPV 6 and 11, the primary causes of RRP. The treatment, which is currently commercially available across the US, reduces the need for the frequent surgeries traditionally required to remove benign respiratory tumors.

Encouraging long-term clinical data presented at the 2026 ASCO Annual Meeting highlighted the treatment’s sustained effectiveness. The study revealed that 83% of complete responders remained surgery-free for at least 36 months without additional treatments, while five patients required no further interventions beyond four years. Precigen Inc. (NASDAQ:PGEN) is a commercial-stage biopharmaceutical company developing gene and cell therapies. While we acknowledge the potential of PGEN as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you re looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: 33 Stocks That Should Double in 3 Years and Cathie Wood 2026 Portfolio: 10 Best Stocks to Buy. Disclosure: None. Follow Insider Monkey on Google News.