pdufa.bio
HomeFDA Decisions › XERS 2025-03-17

XERS FDA Decision Approved · 2025-03-17

Updated ·next FDA decision on the calendar

Price into the decision (T-120)

PDUFA 3/17/25$4.82$2.769/30/24
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
Outcome✓ Approvedprimary-sourced
Decision-day move+4.4%
T-120 run-up (low→high)+75.0% ($2.9→$5.51)
Market-cap tierNano
Cohort decision-day move (history)8.0% median (n=117)

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 Gvoke VialDx approved by the FDA?

Yes. The FDA approved the application for Gvoke VialDx 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.