Page updated ·next FDA decision on the calendar·Data as of Oct 14, 2026 7:39 PM ET
Price into the decision (T-120)
Daily close, T-120 (9/30/24) through T+5. Run-up high $4.82 on 3/14/25, low $2.76 on 10/1/24 (T-120 to T-1). FDA decision 3/17/25. Historical price action, not a forecast.
Positioning before the decision
On Mar 3, 2025, 14 days before the decision date, at-the-money options priced a move of ±35.4% through Mar 21, 2025 (the first listed expiry after the decision; ATM implied volatility 198%). The stock closed +4.4% at the first close across the decision and +20.5% 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 date2025-03-17
DrugGvoke VialDx
IndicationDiagnostic aid for gastrointestinal tract in adult patients
13F reports list long positions in common stock at quarter end, are due 45 days later, and show no short positions or later trades. Notes, warrants and other instruments are not counted as shares.
Questions
Was Gvoke VialDx approved by the FDA?
Yes. The FDA approved the application for Gvoke VialDx on March 14, 2025, per the FDA's own record. The company announced it on March 17, 2025. The primary source is linked on this page.
What was Gvoke VialDx under FDA review for?
The application covered Diagnostic aid for gastrointestinal tract in adult patients. The FDA approved the application on March 17, 2025.
How did XERS stock react to the FDA decision?
On the decision day XERS moved +4.4%. That is the recorded reaction to this specific event. Historical measurement, not a prediction, and not investment advice.