The Telix Pharmaceuticals Ltd (ASX: TLX) share price is back on the move on Thursday.
At the time of writing, the ASX healthcare stock is up 2.56% to $17.46.
That continues a strong run for shareholders, with Telix shares now up around 34% over the past month and 55% since the start of 2026.
The latest gain comes after the company released another update this morning, this time linked to one of its late-stage cancer programs.
Here are the details.
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FDA feedback clears next step
According to the release, Telix has reached an agreement with the FDA to move ahead with the next part of its ProstACT Global Phase 3 study in the US.
The study is looking at TLX591-Tx, a targeted radiation treatment being developed for a serious form of prostate cancer.
This type of prostate cancer has spread to other parts of the body and keeps growing, even after treatment to reduce male hormone levels.
Telix said the FDA reviewed safety data from the first part of the trial, including how much radiation was delivered to patients.
The regulator confirmed the data was enough for Telix to move into Part 2 of the study in the US.
Part 2 is the randomised stage of the trial. It will test TLX591-Tx alongside existing prostate cancer treatments, including abiraterone, enzalutamide, or docetaxel.
What comes after the FDA review
Keep in mind, this isn't a product approval. Telix still needs to run the larger trial and prove the treatment works.
Telix said the FDA agreed with the proposed clinical protocol and statistical framework across 3 standard-of-care treatment groups.
That gives the company a clearer plan for how the next part of the study will run and how the results will be measured.
It also helps Telix keep building the trial in the US, while recruitment continues in other approved regions.
However, the company said Part 2 of the study still needs one more FDA review before it can begin.
What makes the treatment different?
The treatment is aimed at PSMA, which is often found on prostate cancer cells.
Telix describes TLX591-Tx as an antibody-based treatment, whereas other radiopharmaceutical therapies use a small molecule approach.
The idea is to send radiation directly to the cancer cells being targeted.
Telix says the therapy is delivered over about 2 weeks and may be able to fit into existing treatment plans without too much disruption.
Can the rally continue?
After a 34% gain in a month, Telix shares may need a breather.
The FDA update is positive, but the market is likely to focus on the data from the larger study from here.
Until those results come through, the share price may move sideways as investors wait for the next major update.
