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pdufa.bio

177Lu-TLX591

Updated ยทnext FDA decision on the calendar

177Lu-TLX591 is a Telix Pharmaceuticals Limited program. Its next catalyst is a Readout in Nov 2026. Every date links its source.

TLX catalyst hub

All upcoming FDA decision dates on the 2026 PDUFA calendar

About this program

Sponsor: Telix Pharmaceuticals Limited (TLX). We track 7 catalyst events for this program: 6 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

Readout · Jun 2026TLXReadout · Nov 2026TLXReadout · Apr 2027TLXReadout · Jul 2027TLXReadout · Aug 2027TLXReadout · Oct 2027TLXReadout · Dec 2027TLX

Questions

When is 177Lu-TLX591's next FDA decision or readout?

The next tracked catalyst for 177Lu-TLX591 is a Readout in Nov 2026.

What happened at 177Lu-TLX591's most recent FDA decision?

No FDA decision for 177Lu-TLX591 is in our archive yet.

Who makes 177Lu-TLX591?

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.