Very few of the ASX listed companies can match the record of this healthcare stock. Returning excellent gains of more than 100% in last one year, it is on a steady path upwards, finding a place among growing companies to invest in, marked with positive developments.
Telix Pharmaceuticals Limited (ASX: TLX)
On March 21, 2025, the U.S. FDA approved Telix Pharmaceuticals Limited (ASX: TLX) next-generation prostate cancer imaging agent, Gozellix® (TLX007-CDx), a PSMA-PET imaging agent for prostate cancer. The clearance enables more precise PET scans in men with prostate cancer who are suspected to have metastasis or recurrence based on rising PSA levels. Gozellix® offers a unique advantage in the imaging market with an extended shelf life of up to six hours, a broader distribution radius, and more scalable production, helping to address access issues for patients, especially in underserved areas of the U.S.
Telix’s earlier imaging product, Illuccix®, was previously approved by the Brazilian Health Regulatory Agency (ANVISA) on 18 March 2025, its first regulatory approval in Latin America. Illuccix® is currently the sole PSMA-PET imaging agent approved in Brazil for the diagnosis of prostate cancer. This approval expands Telix's reach, giving more Brazilian patients access to advanced imaging for detecting metastasis and recurrence of prostate cancer. The approval is part of a broader collaboration with R2PHARMA, which will manufacture and distribute Illuccix® in Brazil, leveraging local infrastructure to ensure widespread access across urban and rural areas.
On March 12, 2025, it completed the acquisition of FAP-targeting theranostic candidates, a promising group of compounds aimed at treating a variety of solid tumors. The new pipeline includes a lead therapeutic compound, TLX400, which targets Fibroblast Activation Protein (FAP), a pan-cancer marker found in many epithelial cancers. The acquisition bolsters Telix's current urology focus while investigating wider cancer applications with clinically confirmed compounds.
On February 26, 2025, Telix also reached a major achievement with the FDA's approval of its Biologics License Application (BLA) for TLX250-CDx (Zircaix®), an imaging agent for kidney cancer. The agent specifically targets clear cell renal cell carcinoma (ccRCC), the most common and aggressive kidney cancer subtype. The FDA granted Priority Review for this agent, with a decision expected by August 2025. If approved, Zircaix® would transform how kidney cancer is diagnosed and managed, much like the impact PSMA-PET imaging has had in prostate cancer.
For FY2024, Telix achieved total revenue of $783.2 million, driven primarily by the sales of Illuccix®. This represents a 56% increase from the previous year and beats full-year guidance. The company also saw strong growth in its research and development efforts, investing $194.6 million, with a focus on advancing late-stage assets. Telix anticipate its revenue guidance for FY2025 at between $1.18 billion and $1.23 billion, indicating confidence in ongoing strong growth.
(Source: Company's Report)
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