Inovio Stock Soars 300%: First FDA Approval for a DNA Medicine

Inovio Pharmaceuticals (NASDAQ: INO) stock soared more than 300% in after-hours trading on Friday, October 30, 2026, after the U.S. Food and Drug Administration granted accelerated approval to Voceryq — the company's first approved product and, according to Inovio, the first FDA-approved DNA medicine. Reuters put the extended-trading gain at 286% in its first report, and later snapshots showed the move pushing past 300%, while rival Precigen fell about 27% after hours.

What happened?

The FDA granted accelerated approval to Voceryq, previously known as INO-3107, to reduce the frequency of surgery in adults with recurrent respiratory papillomatosis, or RRP. RRP is a rare disease caused by HPV-6 and HPV-11 that produces growths in the airways. Those growths often return, so many patients face repeated surgical procedures to keep their airways clear.

Voceryq is a plasmid DNA-based immunotherapy. Instead of treating only the visible growths, it is designed to generate an immune response against the HPV types that cause the disease. It is given by intramuscular injection using Inovio's CELLECTRA delivery device, which helps the DNA enter cells.

For Inovio, this is a company-changing milestone — its first approved product, and, management says, validation of its DNA-medicine platform.

Why is the stock blowing up?

Three things collided at once. First, the move was a genuine surprise catalyst on a brutal day for markets — the Nasdaq had its worst month since March 2025 as chip and AI stocks sold off — so a clear, positive, company-specific headline stood out sharply. Second, a first approval changes Inovio's story from promise to product: the company now expects revenue, a launch, and a commercial operation. Third, the stock had fallen about 65% year to date before Friday, according to Stocktwits reporting via TradingView, so the starting price was low and after-hours liquidity was thin — a combination that can produce very large percentage moves.

The other side of the trade was just as dramatic. Precigen (NASDAQ: PGEN), whose Papzimeos became the first U.S.-approved medicine for adult RRP last year, dived about 27% after hours. Papzimeos generated $74.7 million in product sales in the first half of 2026, the vast majority of Precigen's revenue, so investors immediately repriced what a direct competitor could mean for that business. Inovio CEO Jacqueline Shea told Reuters that Voceryq differs from Papzimeos because it is DNA-based, while Papzimeos uses a modified virus to trigger an immune response.

Key facts

• Approval type: Accelerated approval, based on complete response — defined as no need for surgical intervention in the 12 months after treatment in the efficacy population.
• Trial behind it: The RRP-001 study enrolled 32 adults who had at least two surgeries in the year before treatment. Reporting on the data noted 27% of patients in the higher-burden group needed no surgery in the first year, and broader summaries said most patients saw surgery frequency fall.
• Safety notes: The FDA listed the most common reactions as injection-site reactions, headache, fatigue, hypertension, nausea and dizziness.
• Designations: Voceryq previously received FDA Orphan Drug and Breakthrough Therapy designations.
• Launch timing: Inovio expects Voceryq to be available to order and ship in about 60 days, with full commercial launch in the first quarter of 2027, working with Syneos Health and commercialising it itself in the United States.
• Next checkpoint: Inovio hosts a conference call on Monday, November 2, 2026 at 8:00 a.m. ET.

What happens next?

Accelerated approval is not the final word. Continued approval depends on a confirmatory study verifying clinical benefit. Inovio must submit a draft protocol for that study to the FDA by the end of 2026, with final protocol alignment expected by mid-2027. If the confirmatory work fails to verify benefit, the FDA can revisit the approval — a risk that matters for a small trial with no control arm.

Investors will also watch pricing, specialist adoption alongside Papzimeos, and whether a first-time seller can build a commercial operation quickly. The next few quarters of actual sales will decide where the stock settles.

Sources: Reuters via Duke FM, Inovio announcement via WCIA, ConsultantLive, TradingView / Stocktwits on Precigen, StockMarketWatch after-hours movers.

FAQ

Why did Inovio stock rise so much?

Inovio surged roughly 286% to more than 300% in extended trading on October 30, 2026 after the FDA granted accelerated approval to Voceryq, the company's first approved product, starting from a share price that had fallen about 65% year to date.

What is Voceryq approved for?

Voceryq is approved to reduce the frequency of surgical papilloma excisions in adults with recurrent respiratory papillomatosis, a rare HPV-driven disease that causes growths in the airways and often requires repeated surgery.

Is Voceryq the first DNA medicine approved in the U.S.?

Yes, according to Inovio. Voceryq is a plasmid DNA-based immunotherapy targeting HPV-6 and HPV-11, and the company describes it as the first U.S. FDA-approved DNA medicine.

When will Voceryq go on sale?

Inovio expects ordering and shipping to begin in about 60 days, with full commercial launch and field deployment in the first quarter of 2027. Continued approval depends on a confirmatory study.