ANAB PDUFA Date: Imsidolimab (ANB019)

Name: Imsidolimab (ANB019) FDA decision
Start: 2026-12-12
End: 2026-12-12

Updated August 7, 2026·next FDA decision on the calendar

FDA decision (PDUFA) target 2026-12-12 · AnaptysBio Inc. · Generalized pustular psoriasis

More Immunology & Inflammation FDA decisions →All December 2026 PDUFA dates →

The story

Imsidolimab (ANB019) is under FDA review to treat generalized pustular psoriasis (GPP) - a rare, severe and painful skin disease.

Full PDUFA calendar ->Every upcoming FDA decision date, by month ARQT . 2026-06-29Same area: Immunology / Dermatology . ZORYVE (roflumilast) Cream 0.3%PFE-brepocitinib . 2026-09-30Same area: Immunology / Dermatology . Brepocitinib EXEL . 2026-12-03Same month decision . XL092 with atezolizumab

Plain-English summary compiled by pdufa.bio from public FDA, SEC and company sources. Informational only - not investment advice.

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

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

Key facts

FDA PDUFA target date2026-12-12

Drug / candidateImsidolimab (ANB019)

IndicationGeneralized pustular psoriasis

CompanyAnaptysBio Inc.

Market-cap tierSmall

Cohort decision-day move (history)±3% median

ClinicalTrials.govNCT05352893

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See the full 2026 PDUFA calendar →

FAQ

When is the ANAB PDUFA date?

The FDA PDUFA target date for ANAB (AnaptysBio Inc.) is 2026-12-12 for Imsidolimab (ANB019). Dates are company/FDA-sourced and can slip. Verify against primary filings.

What is ANAB's drug Imsidolimab (ANB019)?

Imsidolimab (ANB019) is AnaptysBio Inc.'s candidate under FDA review for Generalized pustular psoriasis.

What typically happens to a small-cap stock into a PDUFA date?

Historically, small-cap names had a median decision-day move around ±3% (763-PDUFA cohort, 2024-26). This is historical context by market-cap tier, not a prediction for this drug.

Decision-day move · small-cap cohortn=274 · median +0.0% · 49% up

Distribution of next-day % moves after the FDA decision for small-cap PDUFAs (2020–26). Red = down, green = up, blue = flat (±3%). Historical dispersion, not a forecast.