PGEN Stock Craters 27% After-Hours After Rival Inovio's Rare Disease Drug Receives FDA Approval
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Precigen shares fell 27% in after-hours trading following FDA accelerated approval of Inovio’s Voceryq, a competing treatment for recurrent respiratory papillomatosis.
Recurrent respiratory papillomatosis (RRP) is a rare condition marked by wart-like growths that develop along the respiratory tract, most frequently in the voice box and on the vocal cords.
Precigen's PAPZIMEOS, approved in August 2025, is currently the established commercial immunotherapy for adult RRP.
In the first half of 2026, the company reported net product sales of PAPZIMEOS of $74.7 million, accounting for a vast majority of the company's total revenue of $78.2 million.
Shares of Precigen (PGEN) dived 27% in after-hours trading on Friday after the U.S. Food and Drug Administration approved a rival treatment for recurrent respiratory papillomatosis (RRP), the rare disease for which Precigen's own product is already on the market.
Recurrent respiratory papillomatosis (RRP) is a rare condition marked by wart-like growths that develop along the respiratory tract, most frequently in the voice box and on the vocal cords. There is no cure for the condition, and patients often rely on multiple surgeries to remove the growths.
FDA Clears Inovio's First Product
The FDA granted accelerated approval to Inovio Pharmaceuticals' (INO) Voceryq, a plasmid DNA-based immunotherapy for adults with RRP. The decision marks Inovio's first approved product.
Voceryq is designed to stimulate an immune response against the HPV viruses that cause the wart-like growths in the airways, aiming to reduce the need for repeated surgeries. The approval was supported by an open-label trial of 32 adults; among those with a higher baseline surgery burden, 27% required no surgery in the first year after treatment. The FDA noted that post-approval studi
