pdufa.bio
HomeFDA Decisions › ARGX 2025-04-10

ARGX FDA Decision Approved · 2025-04-10

Updated ·next FDA decision on the calendar

Price into the decision (T-120)

PDUFA 4/10/25$671.745$540.6110/24/24
Daily close, T-120 (10/24/24) through T+5. Run-up high $671.745 on 2/6/25, low $540.61 on 10/24/24 (T-120 to T-1). FDA decision 4/10/25. Historical price action, not a forecast.
Positioning before the decision
On Mar 27, 2025, 14 days before the decision date, at-the-money options priced a move of ±6.7% through Apr 17, 2025 (the first listed expiry after the decision; ATM implied volatility 35%). The stock closed -3.2% at the first close across the decision and +4.2% 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 date2025-04-10
DrugVYVGART Hytrulo (efgartigimod)
IndicationGeneralized myasthenia gravis (gMG), chronic inflammatory demyelinating polyneuropathy (CI
Outcome✓ Approvedprimary-sourced
Decision-day move-3.2%
T-120 run-up (low→high)+10.0% ($546.22→$671.75)
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.

See the full 2026 PDUFA calendar →

Questions

Was VYVGART Hytrulo (efgartigimod) approved by the FDA?

Yes. The FDA approved the application for VYVGART Hytrulo (efgartigimod) on April 10, 2025. The primary source is linked on this page.

What was VYVGART Hytrulo (efgartigimod) under FDA review for?

The application covered Generalized myasthenia gravis (gMG), chronic inflammatory demyelinating polyneuropathy (CI. The FDA approved the application on April 10, 2025.

How did ARGX stock react to the FDA decision?

On the decision day ARGX moved -3.2%. That is the recorded reaction to this specific event -- historical measurement, not a prediction, and not investment advice.