TLX FDA decision: Sep 11, 2026 (announced Sep 14)

Pixclara (floretyrosine F 18; TLX101-Px) was approved by the FDA on September 11, 2026 for PET imaging to characterise recurrent or progressive glioma from treatment-related changes, the 40th novel drug approval of 2026 on the FDA's Novel Drug Approvals list.

Verified against: FDA action day September 11, 2026 (NDA 218592 ORIG-1) · Announcement September 14, 2026 (Telix 6-K) · Goal date September 11, 2026 (Telix release).

Pixclara (floretyrosine F 18, TLX101-Px) approved September 11, 2026, its PDUFA goal date (FDA letter), as the first FDA-approved FET-PET imaging drug for glioma; Telix announced it on September 14.

Run-up into the decision (T-120 → T+5)

Key facts

The PDUFA goal date was September 11, 2026, sourced to Telix's NDA-acceptance release of April 10, 2026. The FDA's approval letter for NDA 218592 is signed September 11, 2026 (Drugs@FDA, letter posted September 15), so the FDA acted on the goal date; Telix announced the approval on Monday, September 14. Between September 20 and 26 this page left the decision out of the timing statistic because the announcement did not state the action day; it was re-admitted when the letter was found. 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.

Primary source: FDA approval letter, NDA 218592, September 11, 2026 (announced in Telix's 6-K of September 14)

FDA record of the action: the FDA approved on September 11, 2026, per NDA 218592 ORIG-1 (FDA letter). The sponsor announced it on September 14, 2026. Action dates on pdufa.bio come from the FDA's own record, not the press release. Every FDA action we hold, by FDA date: FDA approval letters.