Precigen secures seven-year FDA market exclusivity
- Precigen (NASDAQ:PGEN) received FDA orphan drug exclusivity for its PAPZIMEOS treatment, blocking similar drugs for recurrent respiratory papillomatosis for seven years.
- This regulatory milestone extends market exclusivity for the treatment of adult RRP through August 2032.
- Long-term study data indicates 83% of complete responders maintained their response for 36 months or more without needing additional therapy.
Precigen (NASDAQ:PGEN) has been granted FDA orphan drug exclusivity for its product PAPZIMEOS, used to treat adult recurrent respiratory papillomatosis.
This designation provides a period of market protection that prevents the approval of similar drugs for the same indication for seven years.
The company stated that the exclusivity period extends its market protection for the treatment through August 2032.
Pivotal study results also showed that 83% of complete responders maintained their health status for 36 months or longer, and following the announcement the Precigen share price was up at $1.52.
The company continues to analyze the safety and long-term efficacy data to support its broader commercial objectives for the therapy.
Precigen previously focused its development efforts on advancing its gene and cell therapy platform to address various rare and serious medical conditions.
