TLX101-Px had its FDA approval announced by the sponsor on September 14, 2026 (the filing does not state the day the FDA acted) for PET imaging to characterise recurrent or progressive glioma from treatment-related changes. It is a diagnostic, not a treatment; the proposed brand name is Pixclara.
The FDA decided TLX's (Telix Pharmaceuticals Limited) application for TLX101-Px on September 14, 2026: Approved (the sponsor's announcement date; the filing does not state the day the FDA acted). The FDA goal date for this application was 2026-09-11. Verify against the linked primary source.
What is TLX's drug TLX101-Px?
TLX101-Px is Telix Pharmaceuticals Limited's drug whose FDA approval the sponsor announced on September 14, 2026 (FDA action day not stated), for Recurrent or progressive glioma (brain cancer).
What typically happens to a mid-cap stock into a PDUFA date?
Historically, mid-cap names had a median decision-day move around ±2% (763-PDUFA cohort, 2024-26). This is historical context by market-cap tier, not a prediction for this drug.
Decision-day move · mid-cap cohortn=222 · median -0.0% · 49% up
Distribution of next-day % moves after the FDA decision for mid-cap PDUFAs (2020–26). Red = down, green = up, blue = flat (±3%). Historical dispersion, not a forecast.