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Pixclara (floretyrosine F 18; TLX101-Px)

Updated ยทnext FDA decision on the calendar

Pixclara (floretyrosine F 18; TLX101-Px) is a Telix Pharmaceuticals Limited program in PET imaging to characterise recurrent or progressive glioma from treatment-related changes. Every date links its source.

TLX catalyst hub

All upcoming FDA decision dates on the 2026 PDUFA calendar

About this program

Indication under review: PET imaging to characterise recurrent or progressive glioma from treatment-related changes. Sponsor: Telix Pharmaceuticals Limited (TLX). Review status: NDA approved (announced September 14, 2026; goal date September 11) after a March 16, 2026 resubmission following an earlier Complete Response Letter. Pixclara is the first FDA-approved FET-PET imaging agent for glioma, indicated to help differentiate recurrent or progressive glioma from treatment-related change in adults and pediatric patients. Market-cap tier at the time we tracked it: Mid. We track 1 catalyst event for this program: 0 upcoming and 1 in the record. A PDUFA date is the FDA's target date to complete review of a marketing application; a readout is the sponsor's expected date for clinical trial results. What a PDUFA date is · why we do not compare trial results across drugs.

Catalyst history

PDUFA · Sep 11, 2026TLX

Questions

When is Pixclara (floretyrosine F 18; TLX101-Px)'s next FDA decision or readout?

No upcoming catalyst is on our calendar for Pixclara (floretyrosine F 18; TLX101-Px); no FDA decisions are on record below.

What happened at Pixclara (floretyrosine F 18; TLX101-Px)'s most recent FDA decision?

No FDA decision for Pixclara (floretyrosine F 18; TLX101-Px) is in our archive yet.

What is Pixclara (floretyrosine F 18; TLX101-Px) used for?

In our records Pixclara (floretyrosine F 18; TLX101-Px) is under review or in development for PET imaging to characterise recurrent or progressive glioma from treatment-related changes.

Who makes Pixclara (floretyrosine F 18; TLX101-Px)?

Telix Pharmaceuticals Limited (TLX).

Where does this data come from?

FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.

Facts and dates only; not investment advice. Verify against primary FDA, SEC and company filings. pdufa.bio is not affiliated with the FDA.
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