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SLNO FDA Decision Approved · 2025-03-26

Updated ·next FDA decision on the calendar

Price into the decision (T-120)

PDUFA 3/26/25$59.18$42.5410/9/24
Daily close, T-120 (10/9/24) through T+5. Run-up high $59.18 on 11/19/24, low $42.54 on 1/16/25 (T-120 to T-1). FDA decision 3/26/25. Historical price action, not a forecast.
Positioning before the decision
On Mar 12, 2025, 14 days before the decision date, at-the-money options priced a move of ±44.2% through Apr 17, 2025 (the first listed expiry after the decision; ATM implied volatility 182%). The stock closed -2.2% at the first close across the decision and +36.4% 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 date2025-03-26
DrugVYKAT XR (diazoxide choline) extended-release tablets
IndicationPrader-Willi syndrome (PWS)
Outcome✓ Approvedprimary-sourced
Decision-day move-2.2%
T-120 run-up (low→high)+25.0% ($42.54→$71.99)
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 VYKAT XR (diazoxide choline) extended-release tablets approved by the FDA?

Yes. The FDA approved the application for VYKAT XR (diazoxide choline) extended-release tablets on March 26, 2025. The primary source is linked on this page.

What was VYKAT XR (diazoxide choline) extended-release tablets under FDA review for?

The application covered Prader-Willi syndrome (PWS). The FDA approved the application on March 26, 2025.

How did SLNO stock react to the FDA decision?

On the decision day SLNO moved -2.2%. That is the recorded reaction to this specific event -- historical measurement, not a prediction, and not investment advice.