Inovio Pharmaceuticals, Inc. INO
Inovio Pharmaceuticals, Inc. (Nasdaq: INO) is an infectious disease drug developer. Its lead program, INO-3107, is in Phase 3 for recurrent respiratory papillomatosis (RRP) in adults. Its next catalyst on record is INO-3107: FDA PDUFA action date for BLA (accelerated approval review) (October 30, 2026).
Upcoming catalysts
- October 30, 2026INO-3107 — FDA PDUFA action date for BLA (accelerated approval review)
In December 2025, the FDA accepted our BLA for INO-3107 for review under the accelerated approval program as a potential treatment for adults with RRP and set the Prescription Drug User Fee Act (PDUFA) target date for October 30, 2026.
Next further out: INO-3107 — Potential commercial launch following approval (2026). 1 catalyst on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| INO-3107 (with CELLECTRA device) | recurrent respiratory papillomatosis | device-combination | Phase 3 |
| INO-3112 + LOQTORZI (toripalimab) | HPV-16/-18 positive locoregionally advanced oropharyngeal squamous cell carcinoma | device-combination | Phase 2 |
| INO-5412 + Akeso PD-1/CTLA-4 inhibitor | glioblastoma | device-combination | Phase 2 |
| HPV-related anal dysplasia candidate | HPV-related anal dysplasia | device-combination | Phase 1 |
| Ebola vaccine booster candidate | Ebola | vaccine | Phase 1 |
| DPROT / DMAb programs | Fabry disease, hypophosphatasia (rare disease), others | biologic-other | Pre-clinical |
Recent results and decisions
- Aug 12, 2026met Partner ApolloBio's pivotal China Phase 3 of VGX-3100 met its predefined primary efficacy endpoint (announced May 2026), with favorable safety; no numbers given.
The trial successfully met its predefined primary efficacy endpoint and demonstrated an overall favorable safety and tolerability profile.
Filing - Dec 29, 2025accepted FDA accepted the INO-3107 BLA with Standard review and a PDUFA date of October 30, 2026; FDA flagged a potential review issue on eligibility for accelerated approval and plans no advisory committee.
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.
Filing - Nov 10, 2025submitted INOVIO completed its rolling BLA submission for INO-3107 in RRP seeking accelerated approval with priority review requested; file acceptance expected by year-end 2025 and potential PDUFA date in mid-2026 if priority review is granted.
INOVIO completed the rolling submission of its BLA for DNA immunotherapy candidate INO-3107 for the treatment of RRP in adults.
Filing
1 more on record.
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 3 infectious disease companies
- Gilead Sciences, Inc. GILD
- GSK plc GSK
- Moderna, Inc. MRNA
- Vaxcyte, Inc. PCVX
- Vir Biotechnology, Inc. VIR
- Novavax Inc NVAX
- Sinovac Biotech Ltd SVA
- CorMedix Inc. CRMD
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.