pdufa.bio
Home › FDA Decisions › XRTX 2025-04-30

XRTX FDA Decision Approved · 2025-04-30

Page updated ·next FDA decision on the calendar ·Data as of Nov 5, 2026 9:00 PM ET

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)
Market-cap tierNano
Cohort decision-day move (history)8.0% median (n=122)

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 →

Every FDA approval letter and released Complete Response Letter we hold, by FDA action date: FDA approval letters.

Questions

Was XRx-026 approved by the FDA?

Yes. The approval of the application for XRx-026 was announced on April 30, 2025; pdufa.bio holds no FDA record stating the exact day the FDA acted. 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.