Precigen, Inc. (PGEN), a biopharmaceutical company specializing in gene and cell therapies, on Tuesday said that the U.S. Food and Drug Administration or FDA has granted priority review for its Biologics License Application or BLA for PRGN-2012 an investigational gene therapy for adults with recurrent respiratory papillomatosis or RRP.
The PDUFA target action date for the BLA is set for August 27, 2025.
The priority review reduces the BLA review timeline to six months and recognizes the potential of PRGN-2012 to significantly improve the treatment of RRP, a rare and debilitating disease caused by HPV 6 and HPV 11 infections.
If approved, PRGN-2012 will be the first FDA-approved therapy for RRP, which currently has no cure, and patients rely on repeated surgeries that do not address the underlying cause of the disease.
The BLA is supported by data from the Phase 1/2 clinical study, which showed that over 50 percent of patients achieved Complete Response, with more than 85 percent experiencing a reduction in surgeries.
PRGN-2012 was well-tolerated, with no dose-limiting toxicities.
Precigen has also received Breakthrough Therapy Designation and Orphan Drug Designation for PRGN-2012, with ongoing efforts to address the unmet medical need for RRP patients globally.
PGEN closed Monday's (Feb.24 2025) trading at $1.75 down by 8.38 percent. In premarket trading Tuesday the stock is up by 16.57 percent at $2.04 on the Nasdaq.
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