Inovio soars 240% as FDA approves immunotherapy for rare HPV-linked disease

Shares of micro-cap biotech Inovio Pharmaceuticals surged 240% in premarket trading on Monday. The company announced that the U.S. Food and Drug Administration had granted accelerated approval to its treatment for a rare respiratory disease linked to human papillomavirus (HPV). Wall Street sees further upside.

Inovio stock jumped around 240% to $1.99 per share in premarket trading on Monday. The rally followed the company’s announcement that the FDA had granted accelerated approval to its VOCERYQ immunotherapy for adults with recurrent respiratory papillomatosis, a rare disease of the larynx and airways caused by HPV. The disease causes growths called papillomas to repeatedly form in the larynx, requiring surgical removal. The biotech’s treatment essentially trains the immune system to recognize and destroy cells infected with HPV types 6 and 11.

Inovio tested the treatment in 32 patients who had undergone at least two surgeries in the year before treatment. The efficacy evaluation included data from 26 participants who had required at least three surgeries in the preceding year. Seven of them, or 27%, needed no further surgery in the year after treatment.

VOCERYQ thus became Inovio’s first approved drug, according to its site. Another 10 programs are at various stages of clinical trials, while four have yet to start human testing.

The company plans to begin shipping the treatment in approximately 60 days, with a full commercial launch in the first quarter of 2027, according to the press release. A confirmatory study is expected to be conducted to verify VOCERYQ’s clinical benefit. The FDA requires the company to submit a draft protocol by the end of the year, with agreement on a final protocol expected by mid-2027.

On the news, shares of Inovio rival Precigen, which won approval for its recurrent respiratory papillomatosis therapy in 2025, plunged around 20% in premarket trading on Monday.

Inovio stock has fallen 65% year to date. The bulk of the decline came on April 2, after the company announced plans for a share offering. Three Wall Street analysts cover the biotech, with two “buy” ratings versus one “hold.” The average target price of $3.17 per share implies more than 426% upside from the Friday close.