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Home › PDUFA Calendar › VNDA

VNDA PDUFA Date: Imsidolimab (ANB019)

Updated ·next FDA decision on the calendar
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

New to FDA decisions? Read what a PDUFA date is and how often the FDA approves drugs.

See the full 2026 PDUFA calendar →

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% (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
under -30%: 5 of 274 (2%)<-30-30 to -15%: 10 of 274 (4%)-15 to -7%: 25 of 274 (9%)-7 to -3%: 36 of 274 (13%)-3 to +3%: 131 of 274 (48%)±3+3 to +7%: 30 of 274 (11%)+7 to +15%: 21 of 274 (8%)+15 to +30%: 10 of 274 (4%)over +30%: 6 of 274 (2%)>+30
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.