INO-3107 and the PAPZIMEOS precedent · INO-3107 · Oct 30, 2026
What is on the public record before the FDA's October 30, 2026 goal date for INO-3107?
The goal date, no advisory committee planned, an accelerated-approval eligibility question the FDA raised at filing and, by INOVIO's account, has not yet discussed with it, and a confirmatory trial whose design the FDA has yet to comment on.
EphemerisX Research · Published · 4 source documents · 1 min read
Short answer
As of October 8, 2026: the FDA's goal date is October 30, 2026, with no advisory committee planned. The FDA's preliminary conclusion on accelerated-approval eligibility, raised at filing, had not been discussed at the July informal meeting, by INOVIO's account, and the FDA's feedback on the confirmatory trial design was still to come. The precedent the FDA set in August 2025 is in its own review of PAPZIMEOS.
What the evidence shows
The date: The FDA assigned INO-3107 a Prescription Drug User Fee Act (PDUFA) review goal date of October 30, 2026, which is the date by which it intends to take action on the application
8-K · Dec 29, 2025.
The open question the FDA raised at filing: its preliminary conclusion that the Company has not submitted adequate information to justify eligibility for the accelerated approval pathway
8-K · Dec 29, 2025. The latest INOVIO account of it, August 12, 2026: the FDA did not discuss its preliminary comment in the file acceptance letter regarding accelerated approval eligibility
8-K · Aug 12, 2026, and the FDA stated that feedback on the confirmatory trial design would be forthcoming
8-K · Aug 12, 2026.
The precedent: for PAPZIMEOS, FDA accepted a single-arm, open-label Phase 1/2 study as a single adequate and well controlled study with confirmatory evidence for licensure
FDA · Aug 14, 2025 · p. 17, and converted the application from accelerated to traditional approval
FDA · Aug 14, 2025 · p. 18. INOVIO's stated expectation since: unless we demonstrate that INO-3107 provides a clinically meaningful benefit over existing therapies, including PAPZIMEOS
10-K · Mar 12, 2026.
The FDA's decision is not yet public. This page does not predict it; it will be updated from the record when the FDA acts or INOVIO reports. The FDA has published no document on INO-3107, which is not approved: everything about its review here is INOVIO's account.
Follow the thread
- How did PAPZIMEOS go from an accelerated-approval application to a traditional approval?Accelerated converted to traditional
- What did INOVIO say the PAPZIMEOS approval meant for INO-3107?A benefit over existing therapies
- What did the FDA flag when it accepted INO-3107's application?Goal date October 30, 2026
The documents, by date
The passages quoted
FDA Summary Basis for Regulatory Action, August 14, 2025 · page 17
Most notably, FDA accepted a single-arm, open-label Phase 1/2 study as a single adequate and well controlled study with confirmatory evidence for licensure due to RRP's rarity and the impracticality of placebo-controlled designs given the current surgical standard of care.Open at the source →
FDA Summary Basis for Regulatory Action, August 14, 2025 · page 18
converting the application from accelerated to traditional approval based on durability dataOpen at the source →
INOVIO Form 8-K, filed December 29, 2025
The Company filed the BLA under the accelerated approval pathway. In the file acceptance letter, the FDA noted as a potential review issue its preliminary conclusion that the Company has not submitted adequate information to justify eligibility for the accelerated approval pathway. The Company plans to request a meeting with FDA to discuss next steps to remain eligible under the accelerated approval program. The Company is not currently planning to seek approval for INO-3107 under the traditional pathway.Open at the source →
INOVIO Form 8-K, filed December 29, 2025
On December 29, 2025, the Company announced that the FDA has accepted the Company’s BLA for INO-3107 for review as a potential treatment for adults with RRP. The review classification designated by the FDA is Standard. The FDA assigned INO-3107 a Prescription Drug User Fee Act (PDUFA) review goal date of October 30, 2026, which is the date by which it intends to take action on the application. The FDA has indicated that it is not currently planning to hold an advisory committee meeting to discuss this application.Open at the source →
INOVIO Form 10-K, filed March 12, 2026
For example, in light of the FDA’s approval of PAPZIMEOS (zopapogene imadenovec-drba) for the treatment of RRP in adults, we anticipate that the FDA will not approve our BLA for INO-3107 under the accelerated approval pathway unless we demonstrate that INO-3107 provides a clinically meaningful benefit over existing therapies, including PAPZIMEOS.Open at the source →
INOVIO Form 8-K, filed August 12, 2026
An informal clinical meeting was conducted, where INOVIO presented the totality of data supporting INO-3107’s safety and efficacy and highly differentiated approach in treating RRP, along with the company’s rationale for accelerated approval eligibility. During the informal meeting, the FDA did not discuss its preliminary comment in the file acceptance letter regarding accelerated approval eligibility. In addition, the FDA stated that feedback on the confirmatory trial design would be forthcoming.Open at the source →