Telix shares storm higher on big US and China news

Telix Pharmaceuticals Ltd (ASX: TLX) shares are starting the week in a positive fashion.

In morning trade, the radiopharmaceuticals company’s shares are up 2% to $12.25.

Why are Telix shares charging higher?

Investors have been buying the company’s shares today following the release of a major portfolio update.

Telix has provided investors with progress updates across several of its key diagnostic imaging programs, including positive clinical data in China and regulatory developments in the United States.

This includes phase 3 trial results for Telix’s prostate cancer imaging agent, TLX591-CDx, marketed as Illuccix in approved jurisdictions.

According to the release, the company has received positive top-line data from its phase 3 registration study in Chinese patients with biochemical recurrence of prostate cancer.

The study met its primary endpoint, delivering a patient-level positive predictive value of 94.8% for tumour detection. Importantly, its performance remained strong even in patients with very low PSA levels, which is considered a key clinical challenge.

Management believes that these results support a near-term new drug application submission in China, which it has described as a “strategically important” market. Telix is running the program alongside its commercial partner, Grand Pharmaceutical Group, which already has an established presence in the region.

Commenting on the study, Telix’s chief medical officer, Dr. David N. Cade, said:

This is an outstanding result. The primary endpoint of the study was met decisively, with the positive predictive value significantly exceeding the performance threshold agreed with the Chinese regulator. Importantly, the high PPV was consistent even in patients with very low PSA values, and across differing metastatic locations, demonstrating broad clinical applicability. These compelling data will enable Telix and our partner Grand Pharma to submit a New Drug Application for Illuccix in China, a strategically important market.

Telix highlights that in China, there were more than 134,000 men diagnosed with prostate cancer in 2022, increasing by approximately 6% each year.

And in line with government policy supporting wider geographic access to nuclear medicine, the number of PET/CT cameras installed in China is expected to surpass 1,600 by the end of 2025, compared with just 133 in 2010.

Regulatory progress in the United States

Telix also updated the market on the regulatory pathway for two other diagnostic candidates in the United States.

For TLX101-CDx (Pixclara), a PET imaging agent for glioma, the company confirmed that it is finalising its resubmission to the US Food and Drug Administration (FDA) following a Complete Response Letter earlier this year. Management advised that it has had collaborative discussions with the FDA and expects to provide a further update once the resubmission has been accepted.

Meanwhile, the company reported constructive engagement with the FDA regarding TLX250-CDx (Zircaix), its kidney cancer imaging candidate. It notes that a recent Type A meeting aligned Telix and the regulator on addressing chemistry, manufacturing, and controls issues that were previously raised. An additional FDA meeting is scheduled for January to review plans relating to manufacturing comparability data.

Overall, it has been a tough year for Telix, but it does appear to be getting its ducks in a line now.

The post Telix shares storm higher on big US and China news appeared first on The Motley Fool Australia.

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Motley Fool contributor James Mickleboro has no position in any of the stocks mentioned. The Motley Fool Australia’s parent company Motley Fool Holdings Inc. has positions in and has recommended Telix Pharmaceuticals. The Motley Fool Australia has recommended Telix Pharmaceuticals. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Scott Phillips.