Upcoming: FDA decision due today on Inovio's INO-3107
The FDA's target date to decide on Inovio's DNA therapy INO-3107 for a rare airway disease is 30 October 2026. No outcome has been reported yet.
This is an upcoming decision, not an outcome. The US Food and Drug Administration (FDA) has until 30 October 2026 to act on Inovio Pharmaceuticals' application for INO-3107, a DNA-based treatment for adults with recurrent respiratory papillomatosis (RRP), a rare airway disease. We found no report of a decision as of this morning.
What the FDA has to decide
Inovio announced on 29 December 2025 that the FDA had accepted its Biologics License Application (BLA), the request to sell a biological drug, on a standard review. The target date is 30 October 2026. This is a PDUFA date, the goal the FDA sets for itself under the drug-fee law. It is a target, not a guarantee: the agency can approve, reject or ask for more data. The drug has Orphan Drug and Breakthrough Therapy designations, and the FDA said it does not currently plan an advisory committee meeting.
What RRP is and how INO-3107 works
RRP is caused by two strains of the human papillomavirus, HPV-6 and HPV-11. Wart-like growths return in the airway and voice box, can affect the voice, and can block breathing. Surgery to remove them is the usual care, but the growths often regrow, so some patients face repeated operations. Think of mowing a lawn whose roots remain: the cut works, but the grass returns.
INO-3107 is a DNA medicine delivered with a small electrical device that helps cells take it up. Inovio says it trains T cells, the immune system's targeted fighters, to attack cells infected with HPV-6 and HPV-11. In August 2025 the FDA approved a first treatment for the disease, Precigen's Papzimeos, which uses a different, virus-based method. Pharmaceutical Technology reports that 51.4% of its pivotal-trial patients needed no surgery in the 12 months after treatment.
What the evidence shows, and what it does not
All the efficacy figures come from Inovio. In a 32-patient phase 1/2 trial, 72% had a 50% to 100% fall in surgeries over the first year. In a follow-up of 28 of those patients, 86% had that reduction in the second year without further dosing, and half needed no surgery. Side effects were mostly Grade 1, the mildest level, such as injection-site pain and fatigue.
The study was small and had no placebo group. The measures also differ from Papzimeos: Inovio counts a fall of at least half in surgeries, while Papzimeos's headline figure counts patients needing none, so the numbers cannot be compared directly.
The accelerated approval question
Inovio filed for accelerated approval, a route that allows approval on early signs of benefit with later confirmation. Inovio said the FDA's acceptance letter gave a preliminary view that it had not provided enough information to justify that route. Inovio disputes this and said it is not planning to seek approval by the traditional route. MyChesCo reported in May 2026 that a mid-cycle review meeting with the FDA had been completed. What the FDA will conclude is unknown. BiopharmaWatch lists the date but offers only its own probability estimate, which we do not repeat.
What it means for readers
For patients and families, nothing changes today: an approval would apply to the US, and Indian access would depend on separate approval and import routes. No decision has been reported in India. This is not medical advice; treatment choices belong with a specialist.
For investors, MyChesCo reported Inovio had $37.7 million in cash on 31 March 2026, plus about $16 million raised in April, and said this should last past the target date.
What to watch next
Watch for an FDA action or Inovio announcement on or soon after 30 October 2026. If the FDA approves, the label will show whether accelerated approval was used and whether a confirmatory study is required. If it declines or asks for more data, Inovio will have to say what extra trials are needed and how it will fund them.
Key takeaways
- The FDA's target date for deciding on Inovio's INO-3107 is 30 October 2026, and no outcome had been reported at the time of writing.
- The efficacy data come from a 32-patient company-reported study without a placebo group.
- The FDA has said it preliminarily doubts that the filing qualifies for accelerated approval, which Inovio disputes.
- Precigen's Papzimeos has been approved since August 2025, so INO-3107 would be a second option, not the first.
Sources
- [Inovio: FDA accepts BLA for INO-3107 in adults with RRP (29 December 2025)](https://ir.inovio.com/news/news-details/2025/FDA-Accepts-for-Review-INOVIOs-BLA-for-INO-3107-for-the-Treatment-of-Adults-with-Recurrent-Respiratory-Papillomatosis-RRP/default.aspx)
- [BiopharmaWatch: FDA calendar October 2026](https://www.biopharmawatch.com/blog/fda-calendar-october-2026)
- [MyChesCo: Inovio extends funding ahead of critical FDA decision](https://www.mychesco.com/a/news/regional/inovio-extends-funding-ahead-of-critical-fda-decision/)
- [Pharmaceutical Technology: FDA approves Papzimeos as first therapy for HPV-caused airway disease](https://www.pharmaceutical-technology.com/news/fda-approves-papzimeos-as-first-therapy-for-hpv-caused-airway-disease/)
Tags: FDA Inovio Rare disease Biotech PDUFA