Precigen surges on FDA approval for gene therapy

[FDA headquarters in Washington DC.]
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Shares of Precigen (NASDAQ:PGEN [https://seekingalpha.com/symbol/PGEN]) added ~34% in the premarket on Friday after the U.S. Food and Drug Administration (FDA) approved its gene therapy candidate Papzimeos (zopapogene imadenovec-drba) for a tumor condition called recurrent respiratory papillomatosis (RRP).

According to the FDA, the adenoviral vector-based immunotherapy will be available for adults with RRP, a rare chronic disease characterized by benign tumors in the respiratory tract, often in the larynx.

Early this year, the agency accepted Precigen’s (NASDAQ:PGEN [https://seekingalpha.com/symbol/PGEN]) biologics license application for the treatment, granting priority review with a target action date of Aug. 25. [https://seekingalpha.com/pr/20012946-fda-grants-priority-review-to-precigens-bla-for-prgnminus-2012-for-the-treatment-of-adults#hasComeFromMpArticle=false]

The BLA was supported by data from a pivotal Phase 1/2 clinical study, which achieved its primary objectives, as more than 50% of patients reported complete remissions with no need for RRP surgeries within 12 months after receiving Papzimeos.

“Randomized trials are not always needed to approve medical products, and this approval is proof of that philosophy,” said Vinay Prasad, who recently returned to the FDA to lead the agency’s Center for Biologics Evaluation and Research (CBER).

“The FDA will always demand the correct clinical study for the specific [https://www.fda.gov/news-events/press-announcements/fda-approves-first-immunotherapy-recurrent-respiratory-papillomatosis] medical product and disease.”

MORE ON PRECIGEN

* Precigen: August Is Pivotal For This Biotech Innovator [https://seekingalpha.com/article/4799757-precigen-august-is-pivotal-for-this-biotech-innovator]
* Seeking Alpha’s Quant Rating on Precigen [https://seekingalpha.com/symbol/PGEN/ratings/quant-ratings]
* Historical earnings data for Precigen [https://seekingalpha.com/symbol/PGEN/earnings]
* Financial information for Precigen [https://seekingalpha.com/symbol/PGEN/income-statement]