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INO PDUFA Date: INO-3107

Updated ·next FDA decision on the calendar
FDA decision (PDUFA) target 2026-10-30 · Inovio Pharmaceuticals Inc. · HPV 6 and HPV 11-associated Recurrent respiratory papillomatosis
More Cancer & Oncology FDA decisions →All October 2026 PDUFA dates →

The story

INO-3107 is under FDA review to treat recurrent respiratory papillomatosis caused by HPV 6/11 - benign airway tumours that keep coming back. Balance sheet: about 5 months of cash, runway into early 2027 (company-guided). ELEVATED: thin runway around catalyst
Full PDUFA calendar ->Every upcoming FDA decision date, by monthGSK-tebipenem-hbr . 2026-06-18Same area: Infectious disease . Tebipenem HBr (SPR994)SPRO . 2026-06-18Same area: Infectious disease . Tebipenem HBr (SPR994)RHHBY-tecentriq . 2026-10-09Same month decision . Tecentriq (atezolizumab) and Tecentriq
Plain-English summary compiled by pdufa.bio from public FDA, SEC and company sources. Informational only - not investment advice.

INO run-up into the PDUFA (last ~120 days)

$1.89$1.05
Price path to 2026-06-19. Green = local high, red = low/sell-off. Historical price action, not a forecast.

Key facts

FDA PDUFA target date2026-10-30
Drug / candidateINO-3107
IndicationHPV 6 and HPV 11-associated Recurrent respiratory papillomatosis
CompanyInovio Pharmaceuticals Inc.
Market-cap tierMicro
Cohort decision-day move (history)±7% median
ClinicalTrials.govNCT04398433 · Breakthrough Therapy Designation (BTD), Orphan Drug Designation (ODD)

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See the full 2026 PDUFA calendar →

FAQ

When is the INO PDUFA date?
The FDA PDUFA target date for INO (Inovio Pharmaceuticals Inc.) is 2026-10-30 for INO-3107. Dates are company/FDA-sourced and can slip. Verify against primary filings.
What is INO's drug INO-3107?
INO-3107 is Inovio Pharmaceuticals Inc.'s candidate under FDA review for HPV 6 and HPV 11-associated Recurrent respiratory papillomatosis.
What typically happens to a micro-cap stock into a PDUFA date?
Historically, micro-cap names had a median decision-day move around ±5% (763-PDUFA cohort, 2024-26). This is historical context by market-cap tier, not a prediction for this drug.
Decision-day move · micro-cap cohortn=302 · median -0.9% · 43% up
under -30%: 26 of 302 (9%)<-30-30 to -15%: 15 of 302 (5%)-15 to -7%: 24 of 302 (8%)-7 to -3%: 36 of 302 (12%)-3 to +3%: 118 of 302 (39%)±3+3 to +7%: 38 of 302 (13%)+7 to +15%: 19 of 302 (6%)+15 to +30%: 11 of 302 (4%)over +30%: 13 of 302 (4%)>+30
Distribution of next-day % moves after the FDA decision for micro-cap PDUFAs (2020–26). Red = down, green = up, blue = flat (±3%). Historical dispersion, not a forecast.