INO-3107 and the PAPZIMEOS precedent · INO-3107 · Jan – Aug 2026
What has INOVIO disclosed about the FDA's review since December 2025?
A meeting request and an assessment aid; a mid-cycle review with no new significant issues; late-cycle meetings and inspections completed; and an informal meeting at which, INOVIO says, the FDA did not discuss accelerated-approval eligibility.
EphemerisX Research · Published · 4 source documents · 1 min read
Short answer
By INOVIO's account: it asked in January 2026 to meet on accelerated-approval eligibility and submitted an assessment aid; the April mid-cycle review raised no new significant issues; by early August the late-cycle meeting and all scheduled inspections were done. At a July informal meeting, it says, the FDA did not discuss its preliminary commentary on eligibility. INOVIO's filings word that meeting two ways.
What the evidence shows
The 10-K: In January 2026, INOVIO requested a meeting with the FDA to discuss maintaining eligibility for review under the accelerated approval program. The FDA has agreed to meet and requested that INOVIO complete an assessment aid
10-K · Mar 12, 2026.
The May 2026 10-Q: In April 2026, the FDA completed its mid-cycle review of the BLA, where no new significant issues were raised
10-Q · May 13, 2026, and the FDA reiterated their intention to schedule the previously agreed to informal meeting to discuss their preliminary commentary on eligibility for review under the accelerated approval program
10-Q · May 13, 2026.
The August 2026 10-Q: By early August 2026, the FDA had completed its mid- and late-cycle review meetings for the BLA and all scheduled pre-licensure inspections
10-Q · Aug 12, 2026. On the July meeting: During the informal meeting, the FDA did not discuss its preliminary commentary in the file acceptance letter regarding accelerated approval eligibility. The FDA stated that feedback on the confirmatory trial design would be forthcoming
10-Q · Aug 12, 2026.
The July 30, 2026 prospectus supplement, filed before that 10-Q, words it differently: the FDA did not provide feedback on its preliminary commentary in the file acceptance letter regarding accelerated approval eligibility, nor did it provide feedback on our proposed confirmatory trial
424B5 · Jul 30, 2026. It also says that by late July the FDA had also completed five pre-licensure inspections. The FDA has scheduled one additional inspection for early August
424B5 · Jul 30, 2026.
INOVIO's 10-Q for the quarter to June 30, 2026 does not mention an advisory committee. 10-Q · searched The FDA has published no document on INO-3107, which is not approved: everything about its review here is INOVIO's account. The confirmatory trial: Where does INO-3107's confirmatory trial stand in INOVIO's filings?
Follow the thread
- Where does INO-3107's confirmatory trial stand in INOVIO's filings?Design feedback “forthcoming”
The documents, by date
The passages quoted
INOVIO Form 10-K, filed March 12, 2026
In January 2026, INOVIO requested a meeting with the FDA to discuss maintaining eligibility for review under the accelerated approval program. The FDA has agreed to meet and requested that INOVIO complete an assessment aid. We submitted the assessment aid in February 2026 and are waiting to receive a meeting date.Open at the source →
INOVIO Form 10-Q, filed May 13, 2026
In April 2026, the FDA completed its mid-cycle review of the BLA, where no new significant issues were raised. As a part of the mid-cycle review communications, the FDA reiterated their intention to schedule the previously agreed to informal meeting to discuss their preliminary commentary on eligibility for review under the accelerated approval program.Open at the source →
INOVIO Form 424B5, filed July 30, 2026
During the informal meeting, the FDA did not provide feedback on its preliminary commentary in the file acceptance letter regarding accelerated approval eligibility, nor did it provide feedback on our proposed confirmatory trial.Open at the source →
INOVIO Form 424B5, filed July 30, 2026
By late July 2026, the FDA had completed its mid- and late-cycle review meetings for the BLA and had also completed five pre-licensure inspections. The FDA has scheduled one additional inspection for early August.Open at the source →
INO-3107 and the PAPZIMEOS precedent Form 10-Q, filed August 12, 2026
INOVIO's 10-Q for the quarter to June 30, 2026 does not mention an advisory committee.
Open the document →INOVIO Form 10-Q, filed August 12, 2026
By early August 2026, the FDA had completed its mid- and late-cycle review meetings for the BLA and all scheduled pre-licensure inspections. In July 2026, the FDA conducted the previously agreed to informal meeting, during which we presented the totality of data supporting INO-3107's safety and efficacy, its highly differentiated approach to treating RRP, and the rationale for accelerated approval eligibility. We also discussed the current standard of care and the ongoing need for additional therapeutic options. During the informal meeting, the FDA did not discuss its preliminary commentary in the file acceptance letter regarding accelerated approval eligibility. The FDA stated that feedback on the confirmatory trial design would be forthcoming.Open at the source →