Theranostics on the ASX, From Telix and Clarity to the Smaller Radiopharmaceutical Names
Theranostics is the part of biotech that uses one radioactive drug to find a cancer and a matching one to treat it. This second piece in the Biotech and Health Series looks at the ASX companies working in it, as their September quarter reports land and Telix shareholders prepare for the vote on its merger with ITM, expected on 1 December 2026 [R2].
All prices in this piece are as at the close of ASX trading on 5 November 2026.
How a Radiopharmaceutical Works
A radiopharmaceutical is a drug that carries a radioactive atom to a target in the body, usually a protein on the surface of cancer cells. One kind of atom gives off a signal a scanner can see, which makes the drug an imaging agent. Another gives off radiation that damages the cell it attaches to, which makes it a treatment.
Using the two on the same target is called theranostics. The scan shows where the cancer is and whether the target is there. The treatment then goes to the same place. For an investor, it means one company can earn from both the scan and the treatment.
PET scan Positron emission tomography. The patient is injected with a tracer that gives off a weak signal, and the scanner builds a three-dimensional picture of where the tracer has collected. |
Novartis and Pluvicto
The largest commercial example is Novartis. Its Pluvicto is a lutetium-177 treatment aimed at PSMA, a protein found on most prostate cancer cells. Novartis reported Pluvicto sales of US$674 million for the September 2026 quarter, up 20%, and US$1,967 million for the first nine months [R1].
In the same quarter the US Food and Drug Administration (FDA) and China's drug regulator approved Pluvicto, used with hormone therapy, for PSMA-positive prostate cancer that has spread and still responds to hormone therapy [R1]. In plain terms, an established radiopharmaceutical treatment can sell close to US$2 billion in nine months.
FDA approval The US regulator's decision that a drug is safe and effective for a stated use. Until a product is approved it cannot be sold in the United States. |
Telix Pharmaceuticals (ASX: TLX)
Telix is the largest ASX company already selling radiopharmaceuticals, and its sales come mostly from imaging. Illuccix and Gozellix are kits for PSMA-PET scans of prostate cancer. They drove Precision Medicine revenue of US$201 million in the September quarter, up 30%, inside group revenue of US$245 million [R2].
On 14 September 2026 Telix announced FDA approval of Pixclara, which it describes as the first FDA-approved FET-PET drug for telling recurrent glioma, a brain cancer, apart from treatment effects [R3]. Zircaix, its kidney cancer imaging agent, received a Complete Response Letter over third-party manufacturing, and Telix is finalising its resubmission [R2].
Complete Response Letter The FDA's letter saying it cannot approve an application in its current form, and setting out what has to be fixed before it can be looked at again. |
Telix's treatments are moving through trials. TLX591-Tx, a lutetium-177 therapy for prostate cancer, is in the ProstACT Global Phase 3 study, and Telix is finalising an FDA filing to run its second part in the US [R2]. In September Telix agreed to merge with ITM, the Munich isotope maker, for US$1.65 billion upfront, mostly in Telix shares, plus up to US$700 million tied to ITM-11, a neuroendocrine tumour treatment [R2].
Phase 1, 2 and 3 Phase 1 tests safety in a small group. Phase 2 tests whether the drug works and at what dose. Phase 3 is the pivotal or registrational trial, designed to give a regulator the main evidence for approval. |
Clarity Pharmaceuticals (ASX: CU6)
Clarity is building the same model on copper. It pairs copper-64 for imaging with copper-67 for treatment on the same targeting molecule [R4]. Its lead product, SAR-bisPSMA, also targets PSMA in prostate cancer.
Both of its Phase 3 imaging trials have finished recruiting. AMPLIFY dosed 232 patients whose cancer had come back, and CLARIFY dosed its planned 383 participants on 27 October 2026 [R4]. Clarity expects topline results from both in the first half of 2027, and says the trials are intended to support an FDA application [R4]. The earlier investigator-led Co-PSMA trial covered 50 men whose PSA, a blood marker of prostate cancer, had begun to rise after surgery. Its scan was positive in 78% of them, against 36% for the standard gallium-68 scan [R4] (FIG. 01).
The SECuRE trial is testing copper-67 in men whose cancer no longer responds to hormone therapy. In a preliminary read of 19 men at the 8 GBq dose, 63% of those evaluable had a PSA50 response [R4]. Clarity held A$152.9 million in cash at 30 September 2026 [R4].
PSA50 A fall of at least 50% in prostate-specific antigen, a blood marker of prostate cancer. It is an early sign that a treatment is working. Survival is measured separately. |
Topline results The first headline read-out of a trial against its main goals, released before the full data. |
The Smaller ASX Radiopharmaceutical Names
Radiopharm Theranostics (ASX: RAD)
Radiopharm's most advanced product, RAD101, is an imaging agent for brain metastases. It met its Phase 2b primary endpoint, agreeing with MRI on 93% of evaluable lesions, and the company says it has reached alignment with the FDA on a single Phase 3 trial of about 280 patients, with dosing expected to begin in the first half of 2027 [R9]. It held A$7.5 million at 30 September after spending A$10.7 million in the quarter, and has since borrowed A$8 million against its expected R&D tax refund [R5].
Cyclopharm (ASX: CYC)
Cyclopharm's Technegas is a lung imaging agent that shows how air moves through the lungs. The patient breathes in carbon nanoparticles labelled with technetium-99m. The FDA approved it in 2023 [R6]. The US installed base reached 84 systems at 30 September 2026, up from 46 at 31 March, and unaudited US revenue for the quarter was A$1.62 million, up 124% [R6].
OncoSil Medical (ASX: OSL)
OncoSil makes a radioactive device. It places phosphorus-32 microparticles directly into a tumour. On 17 August 2026 it announced FDA approval under a Humanitarian Device Exemption for distal cholangiocarcinoma, a rare bile duct cancer [R7]. Its sales grew on a year earlier [R7]. US supply starts at five academic centres in a 30-patient post-approval study [R7].
Humanitarian Device Exemption A US approval for devices used in rare conditions, granted on safety and probable benefit rather than proof of effectiveness. |
Where the Share Prices Sit
![TABLE 01. Closing share prices of the five ASX companies, against the close a year earlier. Columns: Company, Code, Close 5 November 2026, Close a year earlier, Change. Company Telix Pharmaceuticals; Code TLX; Close 5 November 2026 A$14.08; Close a year earlier A$15.56; Change down 10%. Company Clarity Pharmaceuticals; Code CU6; Close 5 November 2026 A$1.60; Close a year earlier A$4.61; Change down 65%. Company Radiopharm Theranostics; Code RAD; Close 5 November 2026 0.3 cents; Close a year earlier 2.3 cents; Change down 87%. Company Cyclopharm; Code CYC; Close 5 November 2026 46.5 cents; Close a year earlier 63 cents; Change down 26%. Company OncoSil Medical; Code OSL; Close 5 November 2026 67.5 cents; Close a year earlier A$1.35; Change down 50%. Source: Yahoo Finance daily closes [R8], Samso calculation. Year-earlier close is the last session on or before 5 November 2025.](https://static.wixstatic.com/media/8d6c37_e4efd26638d14eb8a0e28b5b10fb82ba~mv2.jpg/v1/fill/w_980,h_402,al_c,q_85,usm_0.66_1.00_0.01,enc_avif,quality_auto/8d6c37_e4efd26638d14eb8a0e28b5b10fb82ba~mv2.jpg)
The trials moved forward over the year while all five share prices, Telix included, fell (TABLE 01). Our reading is that the market is waiting for the trial results before it pays for them. The three smaller names trade below A$1, so a small move in price is a large move in percentage terms.
What Comes Next for ASX Theranostics
Telix plans the Zircaix resubmission in the near term and expects its OPTIMAL-PSMA Phase 2 readout in the first half of 2027 [R2]. Clarity's two Phase 3 results fall in the same half [R4]. Radiopharm is assessing equity and non-dilutive funding as it prepares its Phase 3 [R5]. OncoSil plans its US launch in the second half of FY27, which is January to June 2027 [R7].
Samso Concluding Comments
On the ASX the sector divides by stage. Telix, Cyclopharm and OncoSil have products on sale, mostly for imaging. The drug treatments are still in trials. Pluvicto alone sold more than three times Telix's imaging revenue in the September quarter, on Samso's arithmetic [R1][R2].
Samso has also covered cancer blood tests in Cleo Diagnostics and BCAL Diagnostics.
Samso Take The question for an ASX investor is no longer whether a radiopharmaceutical can work. Pluvicto has shown that a targeted radioactive treatment can work and sell. Which ASX company gets a radioactive drug treatment of its own through the FDA, and what will it cost to get there? |
The other way to read this Large drug companies own the leading treatments and the manufacturing scale, and a better scan still has to replace an approved one that doctors already use. A trial can also meet its goals and still leave the product short of what the market expected. Telix's share price fell over the year while its sales grew (TABLE 01). |
Vocabulary Radiopharmaceutical A drug that carries a radioactive atom to a target in the body, for imaging or treatment. Theranostics Using one radioactive drug to find a cancer and a matching one, on the same target, to treat it. PSMA Prostate-specific membrane antigen, a protein on the surface of most prostate cancer cells. PET scan Positron emission tomography, a scan that shows where an injected radioactive tracer has collected. Isotope A form of an element. Radioactive isotopes such as lutetium-177 and copper-67 are what make these drugs work. Phase 1, 2 and 3 The three stages of human trials, from safety in a small group to the pivotal trial that gives a regulator the main evidence for approval. Complete Response Letter The FDA's letter saying an application cannot be approved in its current form. PSA50 A fall of at least 50% in prostate-specific antigen, a blood marker of prostate cancer. Topline results The first headline read-out of a trial against its main goals. GBq Gigabecquerel, a unit that measures the amount of radioactivity in a dose. Humanitarian Device Exemption A US approval for devices used in rare conditions, granted on safety and probable benefit rather than proof of effectiveness. |
References and Sources
Cover photo. PET-CT scanner room at CERMEP, Bron, France, photographed by Romainbehar, 2019. CC0 public domain dedication, via Wikimedia Commons
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