INO-3107 for Recurrent respiratory papillomatosis (RRP)
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 a rare HPV-driven airway disease with few options beyond repeat surgery.
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.
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Frequently asked questions
When will the FDA decide on INO-3107?
The FDA's target decision date (PDUFA date) for INO-3107 in Recurrent respiratory papillomatosis (RRP) is October 30, 2026, disclosed by INOVIO. The agency can act before this date and occasionally runs past it.
What is INO-3107 being reviewed for?
INOVIO submitted a BLA for INO-3107 in Recurrent respiratory papillomatosis (RRP). DNA immunotherapy for a rare HPV-driven airway disease with few options beyond repeat surgery.
What happens after the INO-3107 decision?
If approved, availability is not immediate: specialty pharmacy setup, insurance review, and patient assistance typically take weeks even when everything goes right. If the FDA issues a complete response letter, the application was not approved in its current form; CRLs are often about manufacturing or data presentation rather than efficacy, and sponsors frequently resubmit. This page updates with the outcome either way.
Where this date comes from
The FDA does not publish PDUFA dates; companies disclose them. This one comes from INOVIO SEC filing. Dates can move, and the FDA can act early or late. This page rechecks against our calendar, which is re-verified weekly.