Stocks

Inovio Shares More Than Triple Premarket After FDA Clears Its First Product; Rival Precigen Falls About 21%

Inovio traded near $1.96 before Monday's open, up from a $0.60 Friday close, after the FDA granted accelerated approval to Voceryq for a rare airway disease. Rival Precigen fell.

Nov 02, 2026 - 07:17

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Shares of Inovio Pharmaceuticals (NASDAQ: INO) more than tripled in premarket trading on Monday, November 2, 2026, after the U.S. Food and Drug Administration granted accelerated approval to Voceryq, the company's first approved product. The stock traded at about $1.96 at 7:10 a.m. ET, according to Yahoo Finance data, compared with a Friday close of $0.6024, a gain of roughly 225%.

Shares of Precigen (NASDAQ: PGEN), whose Papzimeos is already sold for the same rare disease, traded at about $5.49 at the same time, down about 21% from Friday's close of $6.94.

What the FDA approved

The FDA said on Friday, October 30, that it had granted accelerated approval to Voceryq (doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd) for adults with recurrent respiratory papillomatosis, or RRP, a rare disease caused by human papillomavirus types 6 and 11 that leads to wart-like growths in the airways. The agency described it as the first approval in the United States for a plasmid DNA-based immunotherapy.

Voceryq, previously known as INO-3107, is given by intramuscular injection using Inovio's CELLECTRA 5PSP device, which uses brief electrical pulses to help deliver the DNA into cells. Inovio's announcement called it the first FDA-approved DNA medicine.

The approval rests on an open-label study of 32 adults who had two or more surgeries in the year before treatment. Among the 26 patients who had at least three surgeries in the prior 12 months, seven, or 27%, needed no surgery in the year after treatment, according to the FDA and the company. The most common side effects were injection site reactions, headache, fatigue, high blood pressure, nausea and dizziness.

Because it is an accelerated approval, continued approval may depend on a confirmatory study. Inovio said the FDA requires it to submit a draft protocol for that study by the end of 2026, with the expectation of agreeing on a final protocol by mid-2027.

Launch timing

Inovio said it expects Voceryq to be available to order and ship in about 60 days, with full commercial deployment in the first quarter of 2027, and that it has engaged Syneos Health to support its medical and commercial field teams. Based on claims data, the company estimates that at least 25,000 people in the United States have RRP. It scheduled a conference call for 8:00 a.m. ET on Monday to discuss the label and commercial plans.

"We look forward to delivering VOCERYQ to the RRP community and believe it has the potential to become a new standard of care for this devastating disease," Chief Executive Jacqueline Shea said in the release.

The decision came after the stock had fallen sharply. Inovio closed Friday's regular session down 21.95%, and after-hours quotes stood near $2 later that evening, FinancialMarkets.com reported, noting that thin after-hours trading is not a settled price. Before Friday, the shares had traded near $1.24 in late September, according to Yahoo Finance data.

Pressure on Precigen

Precigen's Papzimeos was approved in August 2025 and is the company's only approved drug. It generated $74.7 million in net product sales in the first half of 2026, most of the company's $78.2 million total revenue, Stocktwits reported. Precigen shares fell 27% in after-hours trading on Friday following the Inovio news.

The two treatments differ in how surgery fits into dosing. Papzimeos is given as four injections over 12 weeks, with visible growths removed before treatment and, if present, before the third and fourth doses, while Voceryq's nine-week regimen requires no additional surgery under its dosing protocol, according to a separate Stocktwits report. In their separate studies, 18 of 35 Papzimeos patients, or 51%, and seven of 26 Voceryq patients, or 27%, required no surgery for 12 months after treatment. The trials were not head-to-head comparisons.

Papzimeos generated $53.1 million in second-quarter revenue and has orphan drug exclusivity through August 14, 2032, the report said. Precigen is scheduled to report third-quarter results on Wednesday.