Telix Pharmaceuticals Ltd TLX
Telix Pharmaceuticals Ltd (Nasdaq: TLX) is an oncology drug developer. Its lead program, TLX591-Tx (177Lu-rosopatamab tetraxetan), is in Phase 3 for Metastatic castration-resistant prostate cancer (ProstACT Global). Its next catalyst on record is TLX250-Tx: IND and CTA submissions (US/EU) (2026).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: TLX250-Tx — IND and CTA submissions (US/EU) (2026). 6 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| TLX591-Tx (177Lu-rosopatamab tetraxetan, radio antibody-drug conjugate) | mCRPC; ProstACT Global Phase 3, Part 1 objectives met, Part 2 randomized expansion dosing (first patient December 2025) | radiopharmaceutical | Phase 3 |
| TLX250-Px (Zircaix, 89Zr-girentuximab imaging) | Characterization of renal masses as ccRCC; BLA received CRL August 2025 (CMC); resubmission being prepared | radiopharmaceutical | Phase 3 |
| TLX101-Px (Pixclara, 18F-FET PET) | Glioma imaging; CRL April 2025, NDA resubmitted March 13, 2026 and accepted with PDUFA goal date September 11, 2026; EU MAA (Pixlumi) submitted February 2026 | radiopharmaceutical | Phase 3 |
| TLX101-Tx (131I-iodofalan; IPAX BrIGHT) | Recurrent glioblastoma; Phase 2/3 Part 1 dose optimization enrolling, first patient enrolled | radiopharmaceutical | Phase 3 |
| TLX250-Tx (177Lu-girentuximab; LUTEON) | Advanced or metastatic ccRCC; Phase 2/3 open for recruitment in Australia | radiopharmaceutical | Phase 3 |
| Illuccix / Gozellix BiPASS | Expanded PSMA-PET indications; BiPASS Phase 3 recruiting | radiopharmaceutical | Phase 3 |
| TLX090-Tx (SOLACE) | Pain from osteoblastic bone lesions; Phase 1 dose escalation dosing | radiopharmaceutical | Phase 1 |
| TLX592-Tx (AlphaPRO) | mCRPC | radiopharmaceutical | Phase 1 |
Recent results and decisions
- Oct 29, 2026met COMPETE Phase 3 trial met its primary endpoint of progression-free survival with median PFS of 23.9 months for ITM-11 versus 14.1 months for everolimus.
COMPETE Phase 3 trial met its primary endpoint of progression-free survival (PFS) Statistically significant improvement in median PFS for ITM-11: 23.9 versus 14.1 months for everolimus
Filing - Oct 29, 2026met ITM-11 met its primary endpoint of progression-free survival in COMPETE Phase 3 trial with median PFS of 23.9 months versus 14.1 months for everolimus in Grade 1-2 GEP-NETs.
COMPETE Phase 3 trial met its primary endpoint of progression-free survival (PFS) Statistically significant improvement in median PFS for ITM-11: 23.9 versus 14.1 months for everolimus
Filing - Oct 21, 2026completed enrollment OPTIMAL-PSMA Phase 2 study completed enrollment of 120 patients, with data readout expected in first half of 2027.
OPTIMAL-PSMA14, a Phase 2 study evaluating TLX597-Tx in metastatic androgen pathway modulator-resistant (mAPMR) prostate cancer15, completed enrollment of 120 patients16. A data readout is expected in the first half of 2027.
Filing
22 more on record.
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 3 oncology companies
- Astrazeneca PLC AZN
- Gilead Sciences, Inc. GILD
- Moderna, Inc. MRNA
- Revolution Medicines, Inc. RVMD
- Genmab A/S GMAB
- BioNTech SE BNTX
- Guardant Health, Inc. GH
- Exelixis, Inc. EXEL
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.