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Home › FDA Decisions › TNXP 2025-08-15

TNXP FDA Decision Approved · 2025-08-15

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 8/15/25$61.57$7.382/28/25
Daily close, T-120 (2/28/25) through T+5. Run-up high $61.57 on 8/13/25, low $7.38 on 3/7/25 (T-120 to T-1). FDA decision 8/15/25. Historical price action, not a forecast.

Decision facts

FDA decision date2025-08-15
DrugTonmya (TNX-102 SL) - (RELIEF/RESILIENT)
IndicationFibromyalgia
Outcome✓ Approvedprimary-sourced
Decision-day move-13.8%
T-120 run-up (low→high)+281.0% ($14.96→$61.57)
ValidationVerified 2026-08-12: Drugs@FDA, application NDA219428, action date 2025-08-15
Market-cap tierSmall
Cohort decision-day move (history)3.7% median (n=302)

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 Tonmya (TNX-102 SL) approved by the FDA?

Yes. The FDA approved the application for Tonmya (TNX-102 SL) on August 15, 2025, per the FDA's own record. The primary source is linked on this page.

What was Tonmya (TNX-102 SL) under FDA review for?

The application covered Fibromyalgia. The FDA approved the application on August 15, 2025.

How did TNXP stock react to the FDA decision?

On the decision day TNXP moved -13.8%. That is the recorded reaction to this specific event. Historical measurement, not a prediction, and not investment advice.