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Home › FDA Decisions › TLX 2025-03-21

TLX FDA Decision Approved · 2025-03-21

Updated ·next FDA decision on the calendar

Price into the decision (T-120)

PDUFA 3/21/25$20.93$14.5611/22/24
Daily close, T-120 (11/22/24) through T+5. Run-up high $20.93 on 2/24/25, low $14.56 on 1/15/25 (T-120 to T-1). FDA decision 3/21/25. Historical price action, not a forecast.

Decision facts

FDA decision date2025-03-21
DrugGozellix (TLX007-CDx)
IndicationPSMA-PET imaging agent for prostate cancer
Outcome✓ Approvedprimary-sourced
Decision-day move+1.5%
T-120 run-up (low→high)+41.0% ($14.56→$20.93)
ValidationVerified 2026-08-12: Drugs@FDA, application NDA219592, action date 2025-03-20
Market-cap tierMicro
Cohort decision-day move (history)4.6% median (n=308)

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 Gozellix (TLX007-CDx) approved by the FDA?

Yes. The FDA approved the application for Gozellix (TLX007-CDx) on March 21, 2025. The primary source is linked on this page.

What was Gozellix (TLX007-CDx) under FDA review for?

The application covered PSMA-PET imaging agent for prostate cancer. The FDA approved the application on March 21, 2025.

How did TLX stock react to the FDA decision?

On the decision day TLX moved +1.5%. That is the recorded reaction to this specific event -- historical measurement, not a prediction, and not investment advice.