Inovio’s INO-3107 PDUFA Date (October 30, 2026): What the Filings Show and What They Leave Open

· 9 min read

The FDA’s target action date for Inovio Pharmaceuticals’ Biologics License Application for INO-3107, a DNA medicine for adults with recurrent respiratory papillomatosis (RRP), is October 30, 2026 (Inovio 8-K, December 29, 2025). According to Inovio, the review has passed its scheduled steps: the mid-cycle and late-cycle review meetings are done, the scheduled pre-licensure inspections are complete, and the FDA has said it is not currently planning an advisory committee (Inovio 8-Ks, December 29, 2025 and August 12, 2026). Completed steps are not findings, though. Inovio has not reported what the inspections concluded, and the FDA has not commented publicly.

One question has been open since the day the file was accepted, and the filings do not close it. Inovio applied only for accelerated approval, and in its acceptance letter the FDA wrote that its preliminary conclusion was that Inovio had not submitted adequate information to justify eligibility for that pathway (Inovio 8-K, December 29, 2025). Inovio says it is not currently planning to seek traditional approval instead. The FDA also did not grant the priority review Inovio had asked for (Inovio 8-K, March 12, 2026), and at an informal meeting in July 2026 it gave, per Inovio, no feedback on its preliminary comment (Inovio prospectus supplement, July 30, 2026).

This piece sets out what the public record shows: the review timeline, the clinical data, why an approved competitor changes the accelerated approval question, Inovio’s cash position, and what the data cannot tell us before October 30.

The review so far, in order

Date Event Source
March 18, 2025 Inovio says it resolved a manufacturing issue with the single-use array component of its CELLECTRA delivery device. Inovio 8-K
August 12, 2025 Device verification testing of the CELLECTRA 5PSP complete; rolling submission requested under the Breakthrough Therapy designation. Inovio 8-K
August 14, 2025 FDA approves Precigen’s Papzimeos, the first approved therapy for adults with RRP. FDA press release
November 10, 2025 Rolling BLA completed under the accelerated approval program, with a request for priority review. Inovio 8-K
December 29, 2025 FDA accepts the BLA with a PDUFA target action date of October 30, 2026, flags accelerated approval eligibility as a potential review issue, and is not planning an advisory committee. Inovio 8-K
March 12, 2026 Inovio reports that the FDA granted a standard 10-month review rather than priority review, and agreed to a meeting on eligibility. Inovio 8-K
April 2026 Mid-cycle review completed; per Inovio, no new significant issues were raised. Inovio 8-K (May 13) and prospectus supplement
July 2026 Informal meeting held. Per Inovio, the FDA gave no feedback on its eligibility comment or on the proposed confirmatory trial. By late July, the late-cycle meeting and five pre-licensure inspections were complete. Inovio prospectus supplement, July 30
August 12, 2026 Inovio reports all scheduled pre-licensure inspections complete, and that the FDA said feedback on the confirmatory trial design would be forthcoming. Inovio 8-K
October 30, 2026 FDA target action date. Inovio 8-K

What INO-3107 is

INO-3107 is a DNA medicine: a plasmid encoding the E6 and E7 proteins of HPV-6 and HPV-11, the viruses behind RRP, together with a plasmid encoding interleukin-12, designed to raise T cells against them (Nature Communications, 2025). In RRP, growths in the airway come back after surgery, so patients often need several operations a year. INO-3107 is injected into muscle and followed by electroporation with Inovio’s CELLECTRA device, four doses at day 0 and weeks 3, 6 and 9 (NCT04398433). It holds Breakthrough Therapy and Orphan Drug designations. More on the drug: INO-3107 on BioRadar.

The clinical evidence

The BLA rests on one single-arm trial, RRP-001, in 32 adults who had needed two or more surgeries in the year before treatment (median 4, range 2 to 8), plus RRP-002, a retrospective follow-up that enrolled 28 of them. There is no control group: each patient’s surgeries after treatment are compared with their own year before. All patients had their papillomas removed within 14 days before the first dose (day 0); surgeries on day 0 counted toward the year before, and any surgery after day 0 counted against efficacy. The trial’s primary endpoint was safety; surgeries were a secondary endpoint (Nature Communications, 2025).

Measure Year 1 after the first dose Year 2 (follow-up study)
50% to 100% fewer surgeries (overall response) 72% (23 of 32) 86% (24 of 28)
No surgery during the year (complete response) 28% (9 of 32) 50% (14 of 28)
At least one fewer surgery 81% (26 of 32) 89% (25 of 28)
Mean surgeries per year (4.1 in the year before) 1.7 0.9

Sources: Nature Communications (2025) for year 1, The Laryngoscope (2025) for year 2. Inovio’s November 2025 release gives 91% (21 of 23 evaluable patients) for the year 2 reduction; the published study counts 25 of 28. Two caveats on year 2: a complete response there means no surgery during that year, not two surgery-free years, and five patients received other drugs in year 2 (bevacizumab or pembrolizumab), mostly late in the year (The Laryngoscope, 2025).

On safety, treatment-related adverse events occurred in 13 of 32 patients (41%), all low grade. Three patients (9.4%) had serious adverse events, none considered treatment-related (Nature Communications, 2025), and the follow-up study reported no treatment-related serious adverse events or long-term safety concerns.

Why Papzimeos matters for accelerated approval

For biologics, accelerated approval applies to products that treat serious illnesses and “provide meaningful therapeutic benefit to patients over existing treatments”, for example an “improved patient response over available therapy” (21 CFR 601.40). An approval on this path also requires a confirmatory trial.

Until August 2025 there was no FDA-approved drug therapy for RRP; doctors relied on surgery and off-label drugs such as bevacizumab and cidofovir (The Laryngoscope, 2025). On August 14, 2025, the FDA approved Precigen’s Papzimeos (zopapogene imadenovec), noting that until then no therapies had been approved for RRP (FDA press release). Precigen calls it a full approval (Precigen 8-K, November 2025), and the postmarketing requirement in the FDA’s approval letter is a laboratory safety study on manufacturing, not a confirmatory efficacy trial (FDA approval letter, August 14, 2025). Inovio’s response since then argues exactly the regulatory point: that INO-3107 provides “a meaningful therapeutic benefit over existing treatments” (Inovio 8-K, December 29, 2025).

The two products were tested in different single-arm trials, and their response windows differ, so the numbers are not a head-to-head comparison:

Papzimeos (PGEN) INO-3107 (INO)
Status Approved August 14, 2025 (full approval, per Precigen) Under review for accelerated approval, target date October 30, 2026
Type Non-replicating adenoviral vector immunotherapy DNA medicine given with an electroporation device
Dosing 4 subcutaneous injections on days 1, 15, 43 and 85; debulking before the first dose, and visible papilloma removed before the third and fourth doses if present 4 intramuscular injections with electroporation on day 0 and weeks 3, 6 and 9; debulking within 14 days before the first dose
Patients 35 adults with 3 or more debulking procedures in the prior 12 months 32 adults with 2 or more surgeries in the prior year
Complete response window No surgery in the 12 months after treatment No surgery in the year after the first dose, dosing period included
Complete response 51% (18 of 35); 43% (15 of 35) still in complete response at 24 months 28% (9 of 32) in year 1; 50% (14 of 28) with no surgery during year 2

Sources: Papzimeos prescribing information; Nature Communications and The Laryngoscope (2025). Inovio’s case for a meaningful benefit leans on the regimen, which it says needs no surgeries during the dosing window, and on its year 2 data. Whether the FDA accepts that as a meaningful benefit over Papzimeos is the question the filings leave open.

The money

Inovio had $36.7 million in cash, cash equivalents and short-term investments on June 30, 2026, down from $58.5 million at the end of 2025, before about $18.3 million of net proceeds from a July offering (Inovio 8-K, August 12, 2026). The company expects its cash to last “into late first quarter 2027, through a potential launch of INO-3107, if approved”, a projection that excludes any further capital raising. Its quarterly report states that “management believes that there is substantial doubt about the Company’s ability to continue as a going concern beyond the first quarter of 2027” (Inovio 10-Q, August 12, 2026).

Since July 2025, Inovio has raised about $83 million net in four underwritten offerings: $22.4 million (July 2025), $26.6 million (November 2025), $16.1 million (April 2026) and $18.3 million (July 2026), most with warrants attached; the July 2026 warrants alone cover more than 42 million shares at an exercise price of $1.10 (Inovio 10-K for 2025 and 10-Q, August 2026). It also filed a $300 million shelf registration in July 2026. Shares outstanding rose to 103.4 million on August 10, 2026, about 95% more than a year earlier (Inovio 10-Qs). BioRadar’s Dilution Watch gives Inovio a dilution pressure score of 100 out of 100, a score built from runway, financing tools and share growth rather than a probability. At the historical burn rate, BioRadar estimates about 5.6 months of runway from the June 30 balance alone (how we calculate runway).

The practical point: the company’s guidance leaves about five months between the target action date and the end of its cash runway, so the next financing matters whichever way the FDA decides.

How the stock is set up

  • Price: INO closed at $1.155 on October 7, 2026, a market value of about $119 million on 103.4 million shares.
  • Short interest: 21.4% of the float as of September 15, 2026, about 5 days of average volume to cover (Yahoo Finance data).
  • Options: INO’s November options trade thinly, with bid-ask spreads too wide for BioRadar to publish an options-implied move for this date.
  • How stocks have moved on FDA decisions: of 43 verified decisions in BioRadar’s dataset, 30 were approvals and 13 complete response letters. Approved stocks moved +0.5% on average on the decision day and +1.6% over five days; stocks that received a complete response letter moved -13.7% and -33.1% (How Biotech Stocks Move Around FDA Decisions).

BioRadar’s probability-of-approval model reads the company’s own filings. For INO-3107 it starts from the base rate for BLAs (64%), takes 4 points off for critical cash runway and 15 for the FDA’s flagged eligibility issue, for a score of 45% as of October 8, 2026 (INO page). No historical base rate exists for an application in this position, so treat the score as a rough signal rather than a forecast.

What the data cannot tell us

  • How the FDA will settle eligibility, and what it counts as a meaningful benefit over Papzimeos: a regimen without surgery during dosing, year 2 results, or neither. The only public account is Inovio’s report of the preliminary conclusion, which per Inovio the FDA did not address at the July meeting.
  • The confirmatory trial. Inovio has described a placebo-controlled trial of 100 patients at about 20 US sites (Inovio 8-K, August 12, 2025). Since the Consolidated Appropriations Act, 2023, the FDA may require a confirmatory trial to be underway before it grants accelerated approval (FDA draft guidance, January 2025). The FDA said in August 2026 that design feedback was forthcoming, and a ClinicalTrials.gov search for INO-3107 on October 8, 2026 found only the completed Phase 1/2 trial, which does not show whether preparations are under way.
  • The exact timing. October 30 is the FDA’s target action date. Papzimeos was approved before its target date, and a major amendment can extend a review by three months.
  • The next financing: when, how much and at what price.

Live tracker: INO since this analysisSubscribers

The checkpoints this analysis set out, the price move since Oct 8, 2026 and every SEC filing since, updated as filings land.

  • 🔒 StatusFDA action on the INO-3107 BLA (target date Oct 30, 2026)
  • 🔒 StatusEligibility for accelerated approval
  • 🔒 StatusFDA feedback on the confirmatory trial design
  • 🔒 StatusConfirmatory trial registered on ClinicalTrials.gov
  • 🔒 StatusQ3 10-Q: cash and runway
  • 🔒 StatusNext financing

The price move since the analysis and each checkpoint's status are in the tracker.

Start 7-day free trial →Log in

The analysis above stays free. The tracker is part of the trial and the subscription.

The possible outcomes

  • Accelerated approval. INO-3107 would become the second approved RRP therapy and, per Inovio, the first DNA medicine available in the United States, with a confirmatory trial required. Inovio plans to sell it itself with a contract sales organization (Inovio 8-K, May 13, 2026).
  • A complete response letter on eligibility. Inovio is not currently planning a traditional approval path and has not said what it would do after such a letter; no timeline for the planned randomized trial is public.
  • A complete response letter for other reasons, such as manufacturing or the device.
  • An extension of three months, or an early action before October 30.

What to watch

  • Any FDA action or Inovio 8-K before October 30; BioRadar’s INO page lists Inovio’s new SEC filings in plain English.
  • A ClinicalTrials.gov registration of the confirmatory trial.
  • Inovio’s third-quarter report and its cash balance.
  • Other dates on the upcoming FDA decisions calendar.

We will update this article after the FDA acts.

Sources

BioRadar data (Dilution Watch, runway, short interest and FDA decision statistics) as of October 8, 2026. This article is for information only and is not investment advice.

This data is for informational purposes only, not investment advice. BioRadar does not provide buy/sell recommendations. Past performance does not guarantee future results. Always do your own due diligence.