Case · INOVIO (Nasdaq: INO) · Precigen (Nasdaq: PGEN) · recurrent respiratory papillomatosis

INO-3107 and the PAPZIMEOS precedent: the record before October 30, 2026.

In August 2025 the FDA approved Precigen's PAPZIMEOS, the first therapy for adults with recurrent respiratory papillomatosis. INOVIO had filed INO-3107 for the same disease under the accelerated approval pathway. What the FDA accepted for PAPZIMEOS, how INOVIO has described its effect, what each trial measured, and what INOVIO has disclosed of the review, read from the FDA's documents and both companies' SEC filings. The FDA's goal date for INO-3107 is October 30, 2026. No predictions.

Quotes an FDA documentQuotes a company filingA line joins two questions whose answers quote the same passage. Hover a question to trace it.

What evidence did the FDA accept when it approved PAPZIMEOS?AUG 2025What evidence did the FDAaccept when it approvedPAPZIMEOS?1 document · 3 connectedHow did PAPZIMEOS go from an accelerated-approval application to a traditional approval?DEC 2024 – AUG 2025How did PAPZIMEOS go from anaccelerated-approvalapplication to a traditionalapproval?4 documents · 4 connectedWhat did INOVIO say the PAPZIMEOS approval meant for INO-3107?NOV 2025 – AUG 2026What did INOVIO say thePAPZIMEOS approval meant forINO-3107?5 documents · 5 connectedWhat did the FDA flag when it accepted INO-3107's application?DEC 2025What did the FDA flag when itaccepted INO-3107'sapplication?4 documents · 2 connectedWhat has INOVIO disclosed about the FDA's review since December 2025?JAN – AUG 2026What has INOVIO disclosedabout the FDA's review sinceDecember 2025?4 documents · 1 connectedWhere does INO-3107's confirmatory trial stand in INOVIO's filings?AUG 2025 – AUG 2026Where does INO-3107'sconfirmatory trial stand inINOVIO's filings?5 documents · 3 connected51% vs. 28.1%: the FDA decision behind two RRP treatments2025 – 202651% vs. 28.1%: the FDAdecision behind two RRPtreatments7 documents · 2 connectedHow do INOVIO and Precigen describe each other's product?MAR – AUG 2026How do INOVIO and Precigendescribe each other'sproduct?4 documents · 3 connectedWhat is on the public record before the FDA's October 30, 2026 goal date for INO-3107?OCT 30, 2026What is on the public recordbefore the FDA's October 30,2026 goal date for INO-3107?4 documents · 3 connectedWhat evidence did the FDA accept when it approved PAPZIMEOS?AUG 2025What evidence did the FDA acceptwhen it approved PAPZIMEOS?How did PAPZIMEOS go from an accelerated-approval application to a traditional approval?DEC 2024 – AUG 2025How did PAPZIMEOS go from anaccelerated-approval applicationto a traditional approval?What did INOVIO say the PAPZIMEOS approval meant for INO-3107?NOV 2025 – AUG 2026What did INOVIO say the PAPZIMEOSapproval meant for INO-3107?What did the FDA flag when it accepted INO-3107's application?DEC 2025What did the FDA flag when itaccepted INO-3107's application?What has INOVIO disclosed about the FDA's review since December 2025?JAN – AUG 2026What has INOVIO disclosed aboutthe FDA's review since December2025?Where does INO-3107's confirmatory trial stand in INOVIO's filings?AUG 2025 – AUG 2026Where does INO-3107'sconfirmatory trial stand inINOVIO's filings?How do INOVIO and Precigen describe each other's product?MAR – AUG 2026How do INOVIO and Precigendescribe each other's product?51% vs. 28.1%: the FDA decision behind two RRP treatments2025 – 202651% vs. 28.1%: the FDA decisionbehind two RRP treatmentsWhat is on the public record before the FDA's October 30, 2026 goal date for INO-3107?OCT 30, 2026What is on the public recordbefore the FDA's October 30, 2026goal date for INO-3107?

Prepared from public FDA letters and SEC filings: every quoted passage is matched to the original document, and every “not in” statement comes from a search of the whole document, before it is published. Questions, summaries and connecting sentences are EphemerisX’s wording. Not investment advice. How this research works → · Ask the FDA and SEC Ephemeris →