TLX biotech catalysts & pipeline

TELIX PHARMACEUTICALS LTD · Data as of 2026-10-25

Upcoming catalysts

ITM-11 (177Lu-edotreotide) — Interim data

H1 2027

ITM-11 has completed a successful Phase 3 trial (COMPETE, NCT03049189)4 and fully enrolled a second indication expansion Phase 3 study (COMPOSE, NCT04919226) with an interim analysis expected in H1 2027.

Source filing

ITM-11 (177Lu-edotreotide) — Interim data

H1 2027

Next catalyst: Second interim analysis expected (H1 2027)

Source filing

TLX597-Tx (177Lu-DOTA-HYNIC-panPSMA) — Clinical data readout

H1 2027

OPTIMAL-PSMA14, a Phase 2 study evaluating TLX597-Tx in metastatic androgen pathway modulator-resistant (mAPMR) prostate cancer15, completed enrollment of 120 patients16.

Source filing

ITM-11 (177Lu-edotreotide) — Interim data

H2 2027

Next catalyst: Interim analysis expected (H2 2027)

Source filing

ITM-11 (177Lu-edotreotide) — Regulatory decision

Dec 31

US$100 million upon FDA approval for expected first indication in G1-G2 GEP- NETs no later than December 31, 2027;

Source filing

ITM-11 (177Lu-edotreotide) — Regulatory decision

Dec 31

US$100 million upon FDA approval for G2-G3 GEP-NETs indication no later than December 31, 2030; and

Source filing

ITM-11 (177Lu-edotreotide) — Regulatory decision

Dec 31

US$50 million upon FDA approval for Lung NETs indication no later than December 31, 2031; and

Source filing

Explore the free biotech catalyst calendar