pdufa.bio
HomeFDA Decisions › ETON 2025-05-29

ETON FDA Decision Approved · 2025-05-29

Updated ·next FDA decision on the calendar

Price into the decision (T-120)

PDUFA 5/29/25$20.25$11.4712/12/24
Daily close, T-120 (12/12/24) through T+5. Run-up high $20.25 on 5/23/25, low $11.47 on 4/10/25 (T-120 to T-1). FDA decision 5/29/25. Historical price action, not a forecast.
Positioning before the decision
On May 15, 2025, 14 days before the decision date, at-the-money options priced a move of ±21.5% through Jun 20, 2025 (the first listed expiry after the decision; ATM implied volatility 129%). The stock closed -5.8% at the first close across the decision and -15.6% 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 date2025-05-29
DrugKHINDIVI (ET-400 ( hydrocortisone bioequivalence))
IndicationOral hydrocortisone
Outcome✓ Approvedprimary-sourced
Decision-day move-5.8%
T-120 run-up (low→high)+23.0% ($11.47→$20.25)
Market-cap tierSmall
Cohort decision-day move (history)3.6% median (n=280)

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 KHINDIVI (ET-400 ( hydrocortisone bioequivalence)) approved by the FDA?

Yes. The FDA approved the application for KHINDIVI (ET-400 ( hydrocortisone bioequivalence)) on May 29, 2025. The primary source is linked on this page.

What was KHINDIVI (ET-400 ( hydrocortisone bioequivalence)) under FDA review for?

The application covered Oral hydrocortisone. The FDA approved the application on May 29, 2025.

How did ETON stock react to the FDA decision?

On the decision day ETON moved -5.8%. That is the recorded reaction to this specific event -- historical measurement, not a prediction, and not investment advice.