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-Px (Zircaix): BLA resubmission to FDA (2026).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: TLX250-Px (Zircaix) — BLA resubmission to FDA (2026). 7 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 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 - Oct 21, 2026n/a Mr. Marcin Firek joined Telix as Company Secretary, effective October 21, 2026.
Mr. Marcin Firek will join Telix as Company Secretary, effective October 21, 2026.
Filing - Sep 30, 2026accepted FDA supported an NDA pathway for BiPASS and granted Fast Track Designation.
The FDA has supported an NDA pathway that could facilitate reimbursement and granted Fast Track Designation, which may enable an expedited review.
Filing
10 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
- Merck & Co., Inc. MRK
- Astrazeneca PLC AZN
- Bristol Myers Squibb Co BMY
- BeOne Medicines Ltd. ONC
- Revolution Medicines, Inc. RVMD
- Genmab A/S GMAB
- BioNTech SE BNTX
- 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.