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.
Every FDA approval letter and released Complete Response Letter we hold, by FDA action date: FDA approval letters.
Questions
Was TLX101-CDx approved by the FDA?
Not in this review cycle. A Complete Response Letter, declining to approve the application for TLX101-CDx in its current form, was announced on April 28, 2025. 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.