PGEN Stock Craters 27% After-Hours After Rival Inovio's Rare Disease Drug Receives FDA Approval

• 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.

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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 studies will be needed to confirm clinical benefit.

INO stock soared over 300% after-hours on the approval. The company’s other assets are investigational.

Approval Hikes Direct Competition For PAPZIMEOS

Precigen’s PAPZIMEOS, approved in August 2025, is currently the established commercial immunotherapy for adult RRP and is the company’s only approved drug. The drug brought in $3.4 million in net product sales in 2025, accounting for a major share of the company’s revenue of about $9.7 million. The amount reflected a limited period of sales, provided that the company began shipments only in November.

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

How Did PGEN Retail Traders React?

On Stocktwits, retail sentiment around PGEN stock stayed within the 'bullish' territory over the past 24 hours, while message volume jumped from 'normal' to 'high' levels.

Meanwhile, sentiment around INO stock was within the 'extremely bullish' territory, coupled with 'extremely high' retail chatter.

A Stocktwits user said that despite the approval, INO has a hard road ahead to commercialize its drug. “PGEN still has plenty of runway as a “monopoly” and record revenues and profits,” they said.

Another user opined that Papzimeos will get the company to profitability, while other drugs in its pipeline take it to “another level.”

A third user highlighted that Inovio got accelerated approval for its drug and is required to conduct more studies to prove efficacy, while PGEN’s drug is fully approved.

While INO stock has dropped 65% year-to-date, PGEN has added 66%. 

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