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VNDA PDUFA Date: Imsidolimab (ANB019)

FDA decision (PDUFA) target 2026-12-12 · Vanda Pharmaceuticals 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. Balance sheet: about 19 months of cash, runway ~19 mo (estimated).
Full PDUFA calendar ->Every upcoming FDA decision date, by monthARQT . 2026-06-29Same area: Immunology / Dermatology . ZORYVE (roflumilast) Cream 0.3%PFE-brepocitinib . 2026-09-30Same area: Immunology / Dermatology . BrepocitinibEXEL . 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.

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

$9.56$5.73
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
CompanyVanda Pharmaceuticals Inc.
Market-cap tierSmall
Cohort decision-day move (history)±3% median
ClinicalTrials.govNCT05352893

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FAQ

When is the VNDA PDUFA date?
The FDA PDUFA target date for VNDA (Vanda Pharmaceuticals Inc.) is 2026-12-12 for Imsidolimab (ANB019). Dates are company/FDA-sourced and can slip — verify against primary filings.
What is VNDA's drug Imsidolimab (ANB019)?
Imsidolimab (ANB019) is Vanda Pharmaceuticals 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% (694-PDUFA cohort, 2024–26). This is historical context by market-cap tier, not a prediction for this drug.