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Upcoming FDA decision · October 30, 2026

INO-3107 PDUFA date: FDA decision expected October 30, 2026

The FDA is expected to decide on INO-3107 from Inovio Pharmaceuticals, Inc. in Recurrent respiratory papillomatosis in adults by the PDUFA target action date of October 30, 2026. For Recurrent respiratory papillomatosis in adults. BLA, accelerated approval pathway, standard review. Verified against the company announcement on 2026-10-16.

A PDUFA date is the FDA's target deadline to complete its review of a drug application — approval, a complete response letter (CRL), or an extension are all possible. What is a PDUFA date? This page is research information, not financial advice.

Source: sec.gov · Data checked October 16, 2026. Confirm dates against the company's or the FDA's announcement before acting.

October 30
Target action date
Phase 2
Stage
Verified
Date confidence
—
FDA designations

Questions about this FDA decision

When is the PDUFA date for INO-3107?
The FDA's PDUFA target action date for INO-3107 is October 30, 2026. The FDA can act before that date, and the review can be extended.
What is INO-3107 being reviewed for?
The application under FDA review covers Recurrent respiratory papillomatosis in adults.
Which company is developing INO-3107?
Inovio Pharmaceuticals, Inc. (INO).
What can happen on a PDUFA date?
The FDA approves the application, issues a complete response letter (CRL) listing what must be fixed before approval, or extends the review (typically by three months after a major amendment).