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Home › FDA Decisions › XRTX 2025-04-30

XRTX FDA Decision Approved · 2025-04-30

Updated ·next FDA decision on the calendar

Price into the decision (T-120)

PDUFA 4/30/25$7.7$4.111/13/24
Daily close, T-120 (11/13/24) through T+5. Run-up high $7.7 on 11/19/24, low $4.1 on 2/24/25 (T-120 to T-1). FDA decision 4/30/25. Historical price action, not a forecast.

Decision facts

FDA decision date2025-04-30
DrugXRx-026
IndicationGout
Outcome✓ Approvedprimary-sourced
Decision-day move-0.6%
T-120 run-up (low→high)+10.0% ($4.1→$6.55)
ValidationVerified 2026-08-12: SEC filing 0001171843-25-002624 of 2025-04-30 containing 'approval of'
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 XRx-026 approved by the FDA?

Yes. The FDA approved the application for XRx-026 on April 30, 2025. The primary source is linked on this page.

What was XRx-026 under FDA review for?

The application covered Gout. The FDA approved the application on April 30, 2025.

How did XRTX stock react to the FDA decision?

On the decision day XRTX moved -0.6%. That is the recorded reaction to this specific event -- historical measurement, not a prediction, and not investment advice.