Home › FDA Decisions › TLX 2025-03-21

TLX FDA Decision Approved · 2025-03-21

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

Price into the decision (T-120)

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)4.7% median (n=312)

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 Gozellix (TLX007-CDx) approved by the FDA?

Yes. The FDA approved the application for Gozellix (TLX007-CDx) on March 20, 2025, per the FDA's own record. The company announced it 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.