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ARQT FDA Decision Approved · 2025-10-06

Updated ·next FDA decision on the calendar

Price into the decision (T-120)

PDUFA 10/6/25$21.25$12.944/21/25
Daily close, T-120 (4/21/25) through T+5. Run-up high $21.25 on 10/2/25, low $12.94 on 4/21/25 (T-120 to T-1). FDA decision 10/6/25. Historical price action, not a forecast.
Positioning before the decision
On Sep 22, 2025, 14 days before the decision date, at-the-money options priced a move of ±12.3% through Oct 17, 2025 (the first listed expiry after the decision; ATM implied volatility 59%). The stock closed -0.8% at the first close across the decision and +0.7% five trading days on. A straddle priced weeks out covers ordinary movement plus the event, so this is the move the options market priced through that expiry, not the event-implied move alone. How this compares across 1,000+ decisions.

Decision facts

FDA decision date2025-10-06
DrugZORYVE (roflumilast) Cream 0.05%
IndicationAtopic Dermatitis - ages of 2-5 years old
Outcome✓ Approvedprimary-sourced
Decision-day move-0.8%
T-120 run-up (low→high)+60.0% ($13.26→$21.25)
Market-cap tierMid
Cohort decision-day move (history)2.1% median (n=234)

Cohort move is the historical median absolute decision-day move for this market-cap tier across our run-up study. History, not a prediction.

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Questions

Was ZORYVE (roflumilast) Cream 0.05% approved by the FDA?

Yes. The FDA approved the application for ZORYVE (roflumilast) Cream 0.05% on October 6, 2025. The primary source is linked on this page.

What was ZORYVE (roflumilast) Cream 0.05% under FDA review for?

The application covered Atopic Dermatitis - ages of 2-5 years old. The FDA approved the application on October 6, 2025.

How did ARQT stock react to the FDA decision?

On the decision day ARQT moved -0.8%. That is the recorded reaction to this specific event -- historical measurement, not a prediction, and not investment advice.