Pixclara (floretyrosine F 18, TLX101-Px) approved as the first FDA-approved FET-PET imaging drug for glioma; Telix announced the approval on Sep 14 2026.
Run-up into the decision (T-120 → T+5)
Daily close, T-120 (3/23/26) through T+4. Run-up high $12.42 on 8/20/26, low $8.77 on 3/24/26 (T-120 to T-1). FDA decision 9/14/26. Historical price action, not a forecast.
Key facts
FDA decision date2026-09-14
OutcomeApproved
Drug / candidatePixclara (floretyrosine F 18; TLX101-Px)
IndicationFET-PET imaging of glioma: differentiating recurrent or progressive glioma from treatment-related change, adults and pediatric patients
CompanyTelix Pharmaceuticals Limited
Market-cap tierMid
120-day run-up (T-120→T-1)+23.7%
Cohort decision-day move (history)2.2% median (n=233)
We hold no sourced PDUFA goal date for this application, sourced to Telix's NDA-acceptance release of April 10, 2026. Telix announced on September 14 that the FDA had approved the NDA; the announcement does not state the day the agency acted and Drugs@FDA does not yet hold a Pixclara record, so the decision date here is the announcement date. We do not state how early or late it was: the date held is the day the sponsor announced the approval, and the announcement does not state the day the FDA acted. If the FDA's letter is dated earlier the margin will be corrected from the letter. The NDA was a March 16, 2026 resubmission after an earlier Complete Response Letter.
Run-up figures are the stock's own daily closing path over the 120 trading days before the decision, from our price history. Cohort move is the historical median absolute decision-day move for this market-cap tier. History, not a prediction.
Was Pixclara (floretyrosine F 18; TLX101-Px) approved by the FDA?
Yes. The sponsor announced on September 14, 2026 that the FDA had approved the application for Pixclara (floretyrosine F 18; TLX101-Px); the announcement does not state the day the FDA acted. The primary source is linked on this page.
Which company is behind Pixclara (floretyrosine F 18; TLX101-Px)?
Pixclara (floretyrosine F 18; TLX101-Px) is a Telix Pharmaceuticals Limited (TLX) program. The company announced the FDA decision on September 14, 2026; the company's own announcement is linked on this page.
How did TLX stock trade into the FDA decision?
Measured over the 120 trading days before the decision (T-120 to T-1), TLX moved +23.7%. That is the recorded price path into this specific event -- historical measurement, not a prediction, and not investment advice.
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