pdufa.bio
CalendarDecisionsApprovals/yrTrial oddsLearnResearchMethodology
Home › PDUFA Calendar › ARQT

ARQT PDUFA Date: ZORYVE (roflumilast) Cream 0.3%

FDA decision (PDUFA) target 2026-06-29 · Arcutis Biotherapeutics Inc. · Plaque Psoriasis in Children Ages 2 to 5

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

$28.57$19.5
Price path to 2026-06-19. Green = local high, red = low/sell-off. Historical price action, not a forecast.

Key facts

FDA PDUFA target date2026-06-29
Drug / candidateZORYVE (roflumilast) Cream 0.3%
IndicationPlaque Psoriasis in Children Ages 2 to 5
CompanyArcutis Biotherapeutics Inc.
Market-cap tierMid
Cohort decision-day move (history)±2% median
ClinicalTrials.govNCT04655313 · completed

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

Track this live → price, options (expected move & IV) and the full dashboard
Opens the pdufa.bio app (private beta)

FAQ

When is the ARQT PDUFA date?
The FDA PDUFA target date for ARQT (Arcutis Biotherapeutics Inc.) is 2026-06-29 for ZORYVE (roflumilast) Cream 0.3%. Dates are company/FDA-sourced and can slip — verify against primary filings.
What is ARQT's drug ZORYVE (roflumilast) Cream 0.3%?
ZORYVE (roflumilast) Cream 0.3% is Arcutis Biotherapeutics Inc.'s candidate under FDA review for Plaque Psoriasis in Children Ages 2 to 5.
What typically happens to a mid-cap stock into a PDUFA date?
Historically, mid-cap names had a median decision-day move around ±2% (694-PDUFA cohort, 2024–26). This is historical context by market-cap tier, not a prediction for this drug.