INO-3107 for Recurrent respiratory papillomatosis (RRP)
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The FDA is expected to decide on INO-3107 for Recurrent respiratory papillomatosis (RRP) by October 30, 2026, under a BLA from INOVIO.
What is being decided
INOVIO has a BLA under FDA review for INO-3107 in Recurrent respiratory papillomatosis (RRP). DNA immunotherapy for adults with recurrent respiratory papillomatosis, given as 4 injections into muscle with INOVIO's CELLECTRA device. INOVIO seeks accelerated approval; the FDA accepted the application under standard review and flagged a preliminary view that eligibility for accelerated approval had not been justified. Would be the second RRP treatment after Papzimeos (August 2025).
About the drug
INO-3107: DNA plasmid immunotherapy encoding HPV 6 and HPV 11 antigens, delivered into muscle with electroporation to generate T cells against infected cells. Our full INO-3107 profile covers how it works, side effects in plain language, and its trial history.
What each outcome would mean
An approval starts a second race rather than ending the first one: specialty pharmacy setup, insurance review, and patient assistance typically take weeks even when everything goes right. Our guide to the 90 days after a rare disease approval explains the timeline and the moves families can make on day 1.
A complete response letter would mean the FDA declined to approve in the application's current form. CRLs are often about manufacturing or data presentation rather than efficacy, and resubmission is common. Either way, this page updates with the outcome and what it means.
We'll email you when the decision is public, with what it means in plain language, and when new trials open for Recurrent Respiratory Papillomatosis. Unsubscribe anytime.
Our coverage
Frequently asked questions
When will the FDA decide on INO-3107?
The FDA's target date (PDUFA date) for INO-3107 in Recurrent respiratory papillomatosis (RRP) is October 30, 2026.
Who disclosed it: INOVIO. The FDA does not publish these dates.
Can it move: the FDA can act early, and a major amendment to the application can push the date back 3 months.
What is INO-3107 being reviewed for?
INOVIO submitted a BLA for INO-3107 in Recurrent respiratory papillomatosis (RRP).
What to know: DNA immunotherapy for adults with recurrent respiratory papillomatosis, given as 4 injections into muscle with INOVIO's CELLECTRA device. INOVIO seeks accelerated approval; the FDA accepted the application under standard review and flagged a preliminary view that eligibility for accelerated approval had not been justified. Would be the second RRP treatment after Papzimeos (August 2025).
How it works: DNA plasmid immunotherapy encoding HPV 6 and HPV 11 antigens, delivered into muscle with electroporation to generate T cells against infected cells.
More: the INO-3107 drug page explains it in plain language.
What did the INO-3107 trials show?
The Phase 1/2 trial (NCT04398433) enrolled 32 adults who had needed at least 2 surgeries in the prior year (a median of 4). In the year after treatment, 81% (26 of 32) needed fewer surgeries, 28% needed none, and the median reduction was 3 surgeries.
More: the INO-3107 drug page has the full trial history and sources.
What are the side effects of INO-3107?
In the Phase 1/2 trial, 13 of 32 patients (41%) had treatment-related side effects, all low grade. No serious adverse events were reported in the follow-up study.
More: the INO-3107 drug page lists the warnings in full.
How much will INO-3107 cost?
INOVIO has not announced a price. Drugmakers usually set it around approval.
Help paying: drugmaker programs and charity funds usually open at launch.
Find help: the patient assistance finder lists programs by insurance type.
What happens after the INO-3107 decision?
This page updates with the outcome the day it is announced.
If approved: getting the drug still takes time. Specialty pharmacy setup, insurance review and patient assistance often take weeks. Our guide covers what families can do on day 1.
If not approved: a complete response letter means the FDA declined the application in its current form. Many are about manufacturing or how data were presented, and companies often resubmit.
Where this date comes from
The FDA does not publish PDUFA dates; companies disclose them. This one comes from INOVIO press release, Dec 29 2025. Dates can move, and the FDA can act early or late. This page rechecks against our calendar, which is re-verified daily.