Telix Pharmaceuticals (ASX: TLX) Stages a Comeback as FY25 Update Signals Renewed Momentum

Telix Pharmaceuticals (ASX: TLX) has been one of Australia’s most talked-about biotech stories … a company that once soared on excitement, stumbled through FDA delays and accounting scrutiny, and is now showing early signs of revival. After a turbulent stretch that tested investor patience, the company has released its FY25 (ending December) guidance, and the numbers tell a different story. Management confidence is returning, cash generation is improving, and sentiment appears to be shifting.

In a market where biotech fortunes can change overnight, Telix might be standing at a rare inflection point where execution begins to catch up to ambition. For investors who wrote the company off as another overhyped growth play, this update could be the moment worth a second look.

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Telix Delivers 53% Revenue Growth and Expands Global Reach with Key U.S. Milestone

Telix Pharmaceuticals delivered a strong Q3 result, with revenue reaching USD 206 million, up 53 percent year over year. The performance prompted management to lift full-year guidance from USD 800 million to USD 820 million, reflecting growing confidence in the company’s commercial momentum.

A major catalyst was the announcement that Gozellix, Telix’s proprietary imaging agent, is now fully reimbursed by the U.S. Centers for Medicare and Medicaid Services (CMS). This means hospitals and imaging centers can now claim reimbursement for using Telix’s technology, reducing financial barriers and encouraging wider adoption. With a permanent Level II HCPCS code and Transitional Pass-Through approval, billing becomes simpler, and the financial risk for healthcare providers decreases, a key factor in accelerating scalability.

For Telix, this creates a powerful flywheel: as hospitals integrate its imaging solutions more easily, volumes can grow, pricing remains competitive, and margins strengthen. Meanwhile, Illuccix Telix’s flagship prostate cancer imaging product continues expanding across Europe, now approved in 19 markets including the United Kingdom, Germany, and France, supported by its Belgium-based manufacturing hub.

Telix Advances ProstACT Phase 3 Trial Across Global Markets

Telix Pharmaceuticals continues to make progress with its ProstACT Global Phase 3 trial, a pivotal late-stage study for its prostate cancer treatment. The trial is now open for patient enrollment in Australia, New Zealand, and Canada, while several Asian markets, including China, Singapore, Türkiye, and Japan, have approved it to begin shortly.

This expansion marks a critical milestone for Telix as it moves deeper into the most important stage of clinical testing before potential regulatory approval. Phase 3 trials are designed to confirm both safety and effectiveness across a large and diverse group of patients, providing the final evidence needed to bring a therapy to market.

The Investors Takeaway

Telix Pharmaceuticals has reached a major milestone, becoming the only company with two U.S. Food and Drug Administration–approved PSMA imaging products. This achievement strengthens its position as a global leader in prostate cancer diagnostics and reinforces the credibility of its broader oncology pipeline.

After a challenging period marked by delays and investor caution, Telix’s long-term outlook now appears stronger than ever. With its share price recently trading near yearly lows, the market seems to be undervaluing the company’s commercial momentum and expanding regulatory footprint. As investor confidence rebuilds, this combination of clinical progress and improving sentiment could set the stage for a meaningful rebound in TLX’s share price.