Radiopharmaceuticals and the State of Biotech in 2026

Several areas of biotech, radiopharmaceuticals among them, reported late-stage milestones in 2026. A personalised cancer vaccine, a gene edit made inside the body and an AI-discovered drug all moved forward. This opener to Samso's six-part Biotech and Health Series sets out where each area stands at the end of October 2026, then tests which one is most likely to succeed for an ASX investor. Samso's working answer was radiopharmaceuticals, medicines that carry a radioactive isotope to a cancer cell. It holds on Samso's three tests, although being closest to sales is not the same as the largest share price gain.

All prices in this piece are as at the close of ASX trading on 30 October 2026.

Where Four Areas of Biotech Stand in 2026

Merck and Moderna reported on 19 August 2026 that their personalised mRNA melanoma vaccine, intismeran autogene, met its main goal in a Phase 3 trial [R1b]. Each patient's vaccine is designed from a sample of their tumour. Detailed results were released on 22 October 2026, ahead of the ESMO cancer congress [R1]. The vaccine was given after surgery with Merck's immunotherapy Keytruda. The companies reported it cut the risk of the cancer returning or the patient dying (recurrence-free survival) by 42% against Keytruda alone. The trial had 1,137 patients. The companies say they are engaging with regulators and that the results have been accepted by The New England Journal of Medicine.

Trial phases

A Phase 1 trial tests safety in a small group. Phase 2 tests whether the treatment works and at what dose. Phase 3 is the large trial regulators rely on to approve a medicine. Topline results are the first headline numbers, released before the full data. A placebo is a dummy treatment given to a comparison group.

Intellia Therapeutics reported Phase 3 results in April 2026 for lonvo-z, a one-time CRISPR treatment that switches off a single gene inside the body [R2]. In hereditary angioedema, a rare inherited disease that causes attacks of severe swelling, it cut attacks by 87% against a placebo [R3]. The trial results were published in The New England Journal of Medicine in June. The FDA has accepted Intellia's application under priority review and set a decision date of 10 March 2027. Intellia says lonvo-z would be the world's first approved in-body CRISPR therapy.

mRNA, CRISPR and the FDA

mRNA is a molecule that tells the body's cells which protein to make. CRISPR is a tool that cuts DNA at a chosen point to switch a gene off or change it. The US Food and Drug Administration (FDA) decides whether a medicine can be sold in the United States, the largest drug market. Priority review is its faster review track.

Insilico Medicine dosed the first patient in September 2026 in a Phase 3 trial of rentosertib, a once-daily drug for idiopathic pulmonary fibrosis, a scarring disease of the lungs [R4]. Insilico describes it as the world's first drug candidate discovered and developed using generative AI. The trial plans to enrol 320 patients in China. Its lead investigator expects three to four years from the start of Phase 3 to approval, under favourable conditions.

Novartis sells Pluvicto, a radiopharmaceutical for prostate cancer. On 31 July 2026 Novartis announced that the FDA had approved it for an earlier stage of the disease, which Novartis says nearly doubles the number of eligible patients [R5]. Pluvicto sold US$605 million in the December 2025 quarter alone [R6]. On 21 September 2026 Telix agreed to buy the German radiopharmaceutical company ITM for US$1.65 billion upfront [R7]. Radiopharmaceuticals already have a product earning sales at scale and a recent large deal.

Radiopharmaceuticals and theranostics

A radiopharmaceutical joins a radioactive isotope to a molecule that seeks out a target on cancer cells. For imaging, the isotope gives off a signal that a PET scan picks up. For treatment, it gives off radiation that travels a very short distance and damages the cancer cell. Using a matched pair to find and then treat the same cancer is called theranostics. PSMA is a protein found on prostate cancer cells. It is the target of Pluvicto, Illuccix and Clarity's imaging agent.

Testing Which Area Is Most Likely to Succeed

For an investor, success means a treatment that reaches approval and earns sales, with listed companies that carry the exposure. Samso set each area against three tests in Table 01. Is a product approved and selling? Did 2026 bring a late-stage milestone? Can an ASX investor own it?

Radiopharmaceuticals answer yes on all three. Products are approved and selling, and two ASX companies already sit in the field, one selling and one with two Phase 3 trials due to report in 2027. The vaccine and gene editing results may prove the larger medical advances, but neither has reached sales yet.

ASX Radiopharmaceutical Stocks, Telix and Clarity

Telix Pharmaceuticals (ASX: TLX) sells imaging agents that show cancer on a PET scan. They include Illuccix for prostate cancer and Pixclara for brain tumours. The FDA approved Pixclara in September 2026. Telix reported revenue of US$245 million for the September quarter, up 19% on a year earlier, and expects 2026 revenue at the upper end of its US$950 million to US$970 million guidance [R8]. The ITM purchase adds a lutetium-177 producer and up to US$700 million more in payments tied to ITM's cancer treatment, ITM-11 [R7]. Shareholders vote on 1 December 2026 [R9].

Clarity Pharmaceuticals (ASX: CU6) is a clinical-stage company. It uses copper-64 to image cancer and copper-67 to treat it, a theranostic pair. On 27 October 2026 it reported that CLARIFY, its Phase 3 trial of the prostate cancer imaging agent 64Cu-SAR-bisPSMA, had dosed its planned target of 383 participants [R10]. Clarity expects topline results from CLARIFY and its second Phase 3 imaging trial, AMPLIFY, in the first half of 2027. It intends CLARIFY to support an application to the FDA.

Where the Share Prices Sit

Both share prices fell over the year. Telix's September quarter revenue was 19% higher than a year earlier, and Clarity completed recruitment in both Phase 3 trials. Our reading is that the market is waiting for Clarity's trial results and the outcome of the ITM deal before it pays for that progress.

What Comes Next

Telix shareholders vote on ITM on 1 December 2026. The FDA is due to decide on lonvo-z by 10 March 2027. Clarity expects both Phase 3 readouts in the first half of 2027. Part 2 covers radiopharmaceuticals on the ASX. Later parts cover cancer vaccines and immunotherapy, gene editing, and AI in drug discovery and diagnostics. A closing piece looks at which ASX biotech companies reached approval and sales, and which did not. Obesity is left out because few ASX companies have exposure to it.

The other way to read this

Being closest to sales does not mean the largest share price gain. In Samso's view, the radiopharmaceutical leaders are already well known to the market, while the 2026 results in vaccines and gene editing are newer. Radiopharmaceuticals also rely on a supply chain of short-lived isotopes and specialised manufacturing. Telix's planned FDA resubmission for Zircaix, its kidney cancer imaging agent, follows observations at a third-party manufacturer [R8]. ITM's FDA application for ITM-11, which Telix lists among the conditions of the deal, is also a resubmission [R9].

Samso Concluding Comments

Radiopharmaceuticals are the area of biotech most likely to succeed for an ASX investor, because products are approved and selling. On the ASX, Telix is selling and Clarity is in Phase 3. Telix has taken the path from imaging agent to revenue guidance of up to US$970 million for 2026. Clarity's two Phase 3 readouts in 2027 will show whether a second ASX company can follow Telix, using copper isotopes. The other areas have reported late-stage results and their next milestones are close. On the evidence at the end of October 2026, the commercial proof is furthest along in radiopharmaceuticals.

Samso Take

Biotech in 2026 has delivered proof in more places than at any time we can remember. For the ASX investor, the question is where that proof has already turned into sales. Today that is radiopharmaceuticals. We will test that view in each part of this series.

Vocabulary

FDA

The US Food and Drug Administration, which approves medicines for sale in the United States.

Phase 1, 2, 3

The stages of a clinical trial, from safety in a few people to the large trial used for approval.

Placebo

A dummy treatment given to a comparison group.

PSMA

A protein found on prostate cancer cells.

Radiopharmaceutical

A medicine that carries a radioactive isotope to a target in the body.

Theranostics

Using a matched pair of radiopharmaceuticals to find a cancer and then treat it.

Topline results

The first headline numbers from a trial, before the full data.

References

[R1] Merck and Moderna, results from Phase 3 INTerpath-001 to be presented at ESMO 2026, 22 October 2026 (topline 19 August 2026). Link

[R1b] Merck and Moderna, Phase 3 INTerpath-001 met endpoints of RFS and DMFS, 19 August 2026. Link

[R2] Intellia Therapeutics, Second quarter 2026 financial results and business updates, 6 August 2026 (Phase 3 topline 27 April 2026, NEJM publication June 2026). Link

[R3] Intellia Therapeutics, FDA acceptance of BLA with priority review for lonvo-z, 8 September 2026. Link

[R4] Insilico Medicine, first patient dosed in GENESIS-IPF-3, 10 September 2026. Link

[R5] Novartis, FDA approves Pluvicto for PSMA+ metastatic hormone-sensitive prostate cancer, 31 July 2026. Link

[R6] Novartis, Q4 and full year 2025 results, 4 February 2026. Link

[R7] Telix Pharmaceuticals, ASX announcement, Telix and ITM join forces, 21 September 2026. Link

[R8] Telix Pharmaceuticals, Third quarter 2026 financial performance, 21 October 2026. Link

[R9] Telix Pharmaceuticals, Notice of General Meeting, ASX, 30 October 2026 (meeting 1 December 2026). Link

[R10] Clarity Pharmaceuticals, Registrational Phase III CLARIFY trial target number of participants achieved, ASX, 27 October 2026. Link

[R11] Yahoo Finance, daily closing prices for TLX.AX and CU6.AX, read 31 October 2026. Link

Cover photo: a transaxial PET brain scan taken with 18F-FDG on an ECAT Exact HR+ scanner, by Jens Maus. Released into the public domain by the author, via Wikimedia Commons. The image is shown under the Samso News blue glass on the article cover.

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