INO-3107 and the PAPZIMEOS precedent · INO-3107 · Dec 2025
What did the FDA flag when it accepted INO-3107's application?
As INOVIO reported it: a standard review rather than the priority review it asked for, a goal date of October 30, 2026, no advisory committee planned, and a preliminary conclusion that INOVIO had not justified eligibility for accelerated approval.
EphemerisX Research · Published · 4 source documents · 1 min read
Short answer
INOVIO's 8-K of December 29, 2025 says the FDA accepted the application on standard review with a goal date of October 30, 2026, said it was not planning an advisory committee, and noted as a potential review issue its preliminary conclusion that INOVIO had not submitted adequate information to justify accelerated-approval eligibility. INOVIO said it was not planning to seek traditional approval.
What the evidence shows
The 8-K: 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
8-K · Dec 29, 2025. The FDA has indicated that it is not currently planning to hold an advisory committee meeting to discuss this application
8-K · Dec 29, 2025.
On the 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
8-K · Dec 29, 2025. The Company is not currently planning to seek approval for INO-3107 under the traditional pathway
8-K · Dec 29, 2025.
On the review clock, the 10-K: INOVIO requested a priority review, which is typically 6 months, but the FDA granted a standard 10-month review
10-K · Mar 12, 2026; the May 2026 10-Q: The FDA denied INOVIO’s request for a priority review
10-Q · May 13, 2026. PAPZIMEOS, by Precigen's account, had priority review
10-K · Mar 25, 2026.
Where the pathway began, the 10-K: In 2023, we received feedback from the U.S. Food and Drug Administration (FDA) that the data from our completed trial of INO-3107 could be used to support the submission of a Biologic License Application, or BLA, for review under the FDA’s accelerated approval program
10-K · Mar 12, 2026.
The FDA has published no document on INO-3107, which is not approved: everything about its review here is INOVIO's account. What INOVIO has disclosed since: What has INOVIO disclosed about the FDA's review since December 2025?
Follow the thread
- What did INOVIO say the PAPZIMEOS approval meant for INO-3107?Accelerated-approval eligibility flagged
- What is on the public record before the FDA's October 30, 2026 goal date for INO-3107?Goal date October 30, 2026
The documents, by date
The passages quoted
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
In 2023, we received feedback from the U.S. Food and Drug Administration (FDA) that the data from our completed trial of INO-3107 could be used to support the submission of a Biologic License Application, or BLA, for review under the FDA’s accelerated approval program.Open at the source →
INOVIO Form 10-K, filed March 12, 2026
As part of the submission, INOVIO requested a priority review, which is typically 6 months, but the FDA granted a standard 10-month review with a Prescription Drug User Fee Act (PDUFA) target date set for October 30, 2026.Open at the source →
Precigen Form 10-K, filed March 25, 2026
In February 2025, the FDA granted priority review to Company’s BLA for PRGN-2012, with a PDUFA target action date set for August 27, 2025. On August 14, 2025, the FDA fully approved Papzimeos, marking the Company’s transition from a development-stage to a commercial-stage biopharmaceutical company.Open at the source →
INOVIO Form 10-Q, filed May 13, 2026
The FDA denied INOVIO’s request for a priority review, which is typically 6 months, but assigned a standard 10-month review period with a Prescription Drug User Fee Act (PDUFA) target date of October 30, 2026.Open at the source →