Telix Pharmaceuticals (ASX: TLX) saw its share price climb by more than 12% in early trading today after the US Food and Drug Administration (FDA) granted approval for its prostate cancer imaging agent, Illuccix (kit for preparation of gallium-68 gozetotide). The decision, announced overnight, permits the use of the radiopharmaceutical for PSMA-PET imaging in men with prostate cancer, a key diagnostic tool for staging and recurrence detection.
The approval is a landmark moment for the Melbourne-based biotechnology company, which has been expanding its commercial footprint in Europe and the UK. Telix’s UK subsidiary, based in London, has been working with NHS trusts on clinical adoption of the technology. The company’s shares on the Australian Securities Exchange (ASX) rose from A$18.50 to A$20.80 on the news, though the stock is not directly listed on the FTSE, some UK investors hold it through international trading accounts or exchange-traded funds.
Prostate cancer is the most common cancer in men in the UK, with around 52,000 new cases diagnosed each year. PSMA-PET imaging is increasingly used in NHS hospitals, but access remains variable. The FDA green light could accelerate adoption in the US, a market worth an estimated $2 billion for prostate cancer imaging. Analysts at Bell Potter described the approval as “transformational” for Telix, noting that US sales could begin within weeks.
For UK investors, the rally underscores the potential of specialist biotech firms with dual listings or ADR programmes. However, Telix remains a small-cap stock with higher volatility than blue-chip pharma companies. The company has yet to report profitability, though revenue from Illuccix sales in the US and Europe is expected to narrow losses. No UK-specific pricing or NHS commissioning decisions have been announced.
The broader healthcare sector on the FTSE 100 was flat today, with the index trading at 8,234 points, down 0.1%. Telix’s move highlights the divergence between high-growth biotech and mainstream pharmaceutical stocks, which have been pressured by regulatory uncertainty and patent cliffs. Investors should note that currency fluctuations between the Australian dollar and sterling also affect returns for UK-based holders.