ProstACT Global Phase 3 Study (Part 1) Achieves Primary Objectives
Rhea-AI Summary
Telix (ASX: TLX, NASDAQ: TLX) announced that Part 1 of the ProstACT Global Phase 3 safety and dosimetry lead-in for TLX591-Tx met primary objectives, showing acceptable safety, predictable biodistribution and dosimetry, and no new safety signals. 36 patients were dosed across three combination cohorts; radiation exposure remained below established limits and lesion uptake was observed across cohorts.
Telix has advanced the trial into Part 2 in jurisdictions with approvals and will present Part 1 data to the FDA to seek an IND amendment.
Positive
- Primary objectives achieved in Part 1 safety and dosimetry lead-in
- All 36 patients received both TLX591-Tx doses per protocol
- Radiation exposure to key organs below established safety limits
- Lesion dosimetry showed tumor uptake across all cohorts
- Study advanced into Part 2 and FDA IND amendment planned
Negative
- Grade 4 thrombocytopenia observed in 31% of patients
- Grade 4 neutropenia observed in 25% of patients
- Grade 3 thrombocytopenia in 14% and neutropenia in 22% of patients
Market Reaction – TLX
Following this news, TLX has gained 6.02%, reflecting a notable positive market reaction. Our momentum scanner has triggered 4 alerts so far, indicating moderate trading interest and price volatility. The stock is currently trading at $8.00. This price movement has added approximately $154M to the company's valuation.
Data tracked by StockTitan Argus (15 min delayed). Upgrade to Silver for real-time data.
Key Figures
Market Reality Check
Peers on Argus
Only one momentum peer, ZLAB, appeared with a ~4.55% upside move and no same-day news, indicating today’s TLX development is primarily stock-specific rather than a broad biotech rotation.
Previous Clinical trial Reports
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Jan 16 | Phase 3 trial dosing | Positive | +4.4% | First U.S. patient dosed in BiPASS Phase 3 prostate diagnosis trial. |
| Dec 21 | Portfolio trial update | Positive | +3.2% | Precision medicine update with Illuccix China Phase 3 success and FDA steps. |
| Sep 09 | Phase 3 initiation | Positive | +4.3% | First patient dosed in BiPASS Phase 3 evaluating MRI plus PSMA-PET. |
| Feb 25 | Trial recruitment update | Positive | -6.8% | Miami site recruiting for ProstACT Global TLX591 radiopharmaceutical trial. |
Clinical trial updates have generally been received positively, with three prior same-tag releases showing upside moves and one notable downside divergence.
Over the past year, Telix has repeatedly reported progress across its precision medicine and prostate cancer programs. Prior clinical updates included BiPASS Phase 3 trial initiations and portfolio data with generally positive stock reactions, notably moves of 4.44%, 4.31%, and 3.21% after clinical milestones. One ProstACT Global recruitment update saw a -6.83% move despite constructive trial details. Today’s Part 1 ProstACT Global Phase 3 safety and dosimetry results extend this pattern of steady clinical advancement in prostate cancer.
Historical Comparison
In recent clinical trial announcements, TLX moved an average of 1.28%, with mostly positive reactions but one downside response, suggesting mixed yet generally constructive reception to pipeline milestones.
Clinical updates show a progression from initiating the ProstACT Global and BiPASS Phase 3 programs through site activation and first patient dosing to today’s ProstACT Global Part 1 safety and dosimetry completion in mCRPC.
Market Pulse Summary
The stock is up +6.0% following this news. A strong positive reaction aligns with Telix’s history of constructive responses to clinical trial updates, where prior same-tag news averaged moves of about 1.28%. The completion of ProstACT Global Part 1 with acceptable safety and dosimetry extends its prostate cancer pipeline momentum. Investors would still need to weigh longer-term execution risks, including successful Part 2 enrollment and regulatory dialogue outcomes, when evaluating the durability of any sharp upside move.
Key Terms
dosimetry medical
biodistribution medical
investigational new drug (IND) regulatory
pharmacokinetics medical
standard of care medical
radiation exposure medical
AI-generated analysis. Not financial advice.
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MELBOURNE, Australia and INDIANAPOLIS, March 10, 2026 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”) today announces that Part 1 of the ProstACT Global Phase 3 study, the safety and dosimetry lead-in for its therapeutic candidate – TLX591-Tx (lutetium-177 (177Lu) rosopatamab tetraxetan) – has achieved its primary objectives, demonstrating an acceptable safety and tolerability profile with no new safety signals observed.
Key findings include:
- Tolerability profile supported by dosimetry and low-grade non-hematologic events.
- Lesion dosimetry indicates no difference in absorbed dose profile across cohorts.
- No adverse drug-drug interactions observed in TLX591-Tx combinations.
- Hematologic events are in line with expectations and transient and manageable, with similar rates of recovery across all patient cohorts.
- The results from Part 1 are consistent with prior clinical studies of this first-in-class lutetium radio antibody-drug conjugate (rADC) therapy.
Part 1 of the study confirmed the safety profile, biodistribution and dosimetry of TLX591-Tx administered in two doses, 14 days apart, in combination with one of three standard of care (SOC) therapies: abiraterone, enzalutamide or docetaxel. The patient population comprised prostate-specific membrane antigen (PSMA) positive metastatic castration resistant prostate cancer (mCRPC) patients previously treated with one androgen receptor pathway inhibitor (ARPI).
ProstACT Global is a differentiated Phase 3 trial comparing PSMA-targeted 177Lu-rADC therapy administered with SOC versus SOC alone, a trial design intended to reflect current global clinical practice1. Telix has already advanced the study into Part 2 – a 2:1 randomized treatment expansion – in jurisdictions where the clinical trial has obtained approval from health authorities2. Part 1 data will be presented to the United States (U.S.) Food and Drug Administration (FDA) to seek an Investigational New Drug (IND) amendment to progress Part 2 in the U.S.
Neeraj Agarwal, MD, Professor of Medicine and Presidential Endowed Chair of Cancer Research at Huntsman Cancer Institute, Salt Lake City, and ProstACT Global Principal Investigator and Steering Committee member, commented, “These results reinforce the feasibility of integrating TLX591-Tx with current standard of care therapies for mCRPC, including ARPIs such as enzalutamide or abiraterone, or docetaxel. Hematologic events align with those typically seen in this patient population and therapeutic class, and these cases resolved quickly. The dosimetry profile, along with the low-grade nature of non-hematologic adverse events, further supports the tolerability profile of this investigational therapy.”
David N. Cade, MD, Group Chief Medical Officer, Telix added, “Despite advances in clinical practice, men with advanced prostate cancer still need improved first and second line treatment options. These results build on prior findings and highlight the potential for TLX591-Tx in combination with contemporary standard of care, to become a new first-line option for patients facing this aggressive disease. We are encouraged by the data and look forward to engaging with the FDA at the earliest opportunity, while continuing to advance enrollment in Part 2 in regions where clinical trial initiation has already been approved.”
Summary results
ProstACT Global Part 1 dosed 36 patients, allocated across 3 cohorts:
- Cohort 1 (11 patients): TLX591-Tx + enzalutamide.
- Cohort 2 (11 patients): TLX591-Tx + abiraterone.
- Cohort 3 (14 patients): TLX591-Tx followed by docetaxel.
Safety and tolerability
- An acceptable safety profile was observed across combination cohorts and tolerability of TLX591-Tx was consistent with prior studies.
- All 36 patients received both doses of TLX591-Tx per protocol, no new safety signals were observed.
- Almost all treatment-emergent non-hematologic events were Grade 1 or Grade 2. The most prevalent were fatigue (
53% ), nausea (28% ) and dry mouth (25% ). - Hematologic events were transient and manageable.
- Grade 3 thrombocytopenia (
14% ) and neutropenia (22% ), and Grade 4 thrombocytopenia (31% ) and neutropenia (25% ) events were in line with the profile expected for this class of therapy and extent of disease.
Dosimetry and biodistribution
- Radiation exposure to key organs was well below established safety limits3.
- Limited dose to salivary glands and kidneys.
- Lesion dosimetry demonstrated uptake across tumor sites and across all cohorts.
- Pharmacokinetics demonstrated sustained activity at 15 days, corroborated by imaging which demonstrated prolonged tumor retention.
- No evidence of drug-drug interactions impacting TLX591-Tx targeting, distribution or clearance.
About ProstACT Global
ProstACT Global (ClinicalTrials.gov ID: NCT06520345) is an international, multicenter trial in two parts: Part 1, safety and dosimetry lead-in with 36 patients (complete); and Part 2, 2:1 randomized global expansion with an overall target enrollment of approximately 490 patients. Eligible patients must have confirmed progressive mCRPC assessed with a 68Ga-PSMA-11 PET4 imaging agent (such as Illuccix®, kit for the preparation of gallium-68 (68Ga) gozetotide injection, or Gozellix®, kit for the preparation of gallium-68 (68Ga) gozetotide injection) following prior treatment with one ARPI.
The antibody approach demonstrates different targeting and pharmacology to that observed in other PSMA-targeted small molecule radioligand therapies (RLT). In contrast to these therapies5, collective long-term follow-up of patients administered with TLX591-Tx has not observed significant acute or delayed kidney toxicity, as the agent is primarily cleared through the liver, a comparatively radioresistant organ, instead of the kidneys6. Due to its large molecular weight, TLX591-Tx also demonstrates minimal salivary and lacrimal gland uptake, reducing dry mouth and dry eyes, common adverse effects of existing PSMA-targeted RLTs7.
Additional information on the Phase 3 ProstACT Global study can be found at: https://telixpharma.com/prostact/
About Telix Pharmaceuticals Limited
Telix is a global biopharmaceutical company focused on the development and commercialization of therapeutic and diagnostic radiopharmaceuticals and associated medical technologies, with the goal to address significant unmet medical needs in oncology and rare diseases. With international operations in the United States, United Kingdom, Brazil, Canada, Europe (Belgium and Switzerland), and Japan, Telix is headquartered in Melbourne, Australia. Telix is listed on the Australian Securities Exchange (ASX: TLX) and the Nasdaq Global Select Market (NASDAQ: TLX).
Telix’s Precision Medicine franchise includes llluccix®, approved in multiple markets globally, and Gozellix®, approved by the U.S. FDA8. TLX591-Tx has not received a marketing authorization in any jurisdiction.
Visit www.telixpharma.com for further information about Telix, including details of the latest share price, ASX and U.S. Securities and Exchange Commission (SEC) filings, investor and analyst presentations, news releases, event details and other publications that may be of interest. You can also follow Telix on LinkedIn, X and Facebook.
| Telix Investor Relations (Global) | Telix Investor Relations (Australia) | Telix Investor Relations (U.S.) |
| Ms. Kyahn Williamson | Ms. Charlene Jaw | Ms. Annie Kasparian |
| SVP Investor Relations and Corporate Communications | Associate Director Investor Relations | Director Investor Relations and Corporate Communications |
| kyahn.williamson@telixpharma.com | charlene.jaw@telixpharma.com | annie.kasparian@telixpharma.com |
Media Contact
Eliza Schleifstein
917.763.8106 (Mobile)
Eliza@schleifsteinpr.com
This announcement has been authorized for release by the Telix Pharmaceuticals Limited Disclosure Committee on behalf of the Board.
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1 National Comprehensive Cancer Network® Clinical Practice Guidelines in Oncology for Prostate Cancer V3.2026; Narayan et al. Clin Genitourin Cancer. 2024.
2 Part 2 is enrolling in Australia, New Zealand, and Canada, and has also received regulatory approval to commence in China, Singapore, South Korea, Türkiye, and the United Kingdom.
3 Wahl et al. J Nucl Med. 2021; Emami et al. Int J Radiat Oncol Biol Phys. 1991.
4 Positron emission tomography.
5 Tagawa et al. Curr Oncol Rep. 2021; Steinhelfer et al. J Nucl Med. 2024.
6 Tagawa et al. Cancer. 2019.
7 Pepin et al. Pract Radiat Oncol. 2025.
8 Telix ASX disclosure March 21, 2025.
FAQ
What did Telix (TLX) report about ProstACT Global Part 1 safety on March 9, 2026?
How many patients were dosed in ProstACT Global Part 1 and what were the cohorts for TLX (TLX)?
What hematologic adverse events did Telix (TLX) observe in ProstACT Global Part 1?
Does ProstACT Global Part 1 show TLX591-Tx interacts with standard of care therapies for TLX (TLX)?
What are Telix's next regulatory and clinical steps for TLX591-Tx after ProstACT Global Part 1?
