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TLX FDA Decision CRL · 2025-04-28

Updated September 3, 2026·next FDA decision on the calendar

The FDA's own letter · Complete Response Letter, NDA 218592 (PDF), dated April 28, 2025, released under FDA's CRL transparency program.

Price into the decision (T-120)

Daily close, T-120 (11/25/24) through T+5. Run-up high $20.93 on 2/25/25, low $13.61 on 4/7/25 (T-120 to T-1). FDA decision 4/28/25. Historical price action, not a forecast.

Decision facts

FDA decision date2025-04-28

DrugTLX101-CDx

IndicationProgressive or recurrent glioma

Outcome✗ CRLprimary-sourced

Decision-day move-6.5%

T-120 run-up (low→high)+27.0% ($13.61→$20.93)

ValidationVerified 2026-08-12: SEC filing 0002007191-25-000049 of 2025-04-29 containing 'complete response letter'

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 TLX101-CDx approved by the FDA?

Not in this review cycle. On April 28, 2025 the FDA issued a Complete Response Letter, declining to approve the application for TLX101-CDx in its current form. A CRL is not final; the primary source is linked on this page.

What was TLX101-CDx under FDA review for?

The application covered Progressive or recurrent glioma. The FDA declined to approve the application in its current form on April 28, 2025.

How did TLX stock react to the FDA decision?

On the decision day TLX moved -6.5%. That is the recorded reaction to this specific event -- historical measurement, not a prediction, and not investment advice.