Highlights

• Telix Pharmaceuticals secured U.S. FDA approval for Pixclara® on 14 September 2026, establishing Pixclara® as the first FDA-approved FET-PET imaging drug for glioma.
• H1 FY26 revenue increased 22% to US$477.35 million, supported by strong growth from Illuccix® and Gozellix® sales.
• The company achieved profitability with net profit of US$38.33 million, while continuing investment across its late-stage therapeutic pipeline.

Telix Strengthens Radiopharmaceutical Leadership

Telix Pharmaceuticals Limited (ASX: TLX) continues to expand its position in the global radiopharmaceutical market following strong financial growth and a major regulatory milestone. The company on 20 August 2026 reported H1 FY26 revenue of US$477.35 million, up from US$390.36 million in the prior corresponding period, while net profit after tax attributable to shareholders reached US$38.33 million, compared with a US$2.29 million loss previously.

The company’s growth has been driven by increasing commercial adoption of its Precision Medicine portfolio, particularly Illuccix® and Gozellix®, alongside continued investment in next-generation diagnostic and therapeutic radiopharmaceuticals.

FDA Approval Opens New Market Opportunity

Telix, on 14 September 2026 reached a major regulatory milestone after the FDA approved Pixclara® (floretyrosine F 18), a PET imaging agent developed to assist clinicians in distinguishing returning or advancing glioma from changes caused by previous treatments.

Pixclara® has achieved a significant regulatory milestone by becoming the first FET-PET imaging agent approved by the FDA for glioma diagnosis. Pixclara® addresses a significant gap in brain cancer diagnostics, given that gliomas represent roughly 30% of brain and central nervous system tumours and make up nearly 80% of malignant brain tumour cases. With nearly 24,000 new glioma cases reported each year in the United States, the approval could expand access to FET-PET imaging for glioma diagnosis in the U.S., addressing an identified unmet need in brain cancer diagnostics.

Commercial Growth Supports Financial Momentum

Telix’s Precision Medicine division remained the key earnings contributor, generating US$388.63 million in revenue, an increase of 27% year-over-year. Growth was supported by higher sales volumes, improved pricing and increased market share for its PSMA-PET imaging franchise. Gross profit increased to US$260.35 million, while gross margin improved to 55%, reflecting a favourable product mix and stronger performance from high-value Precision Medicine products. The company continued expanding its development pipeline, with research and development expenditure rising 52% to US$123.83 million as it advanced late-stage therapeutic programs and regulatory submissions.

Expanding Pipeline Supports Future Growth

Telix continues advancing a broad portfolio of clinical-stage therapies, with key programs targeting prostate cancer through TLX591-Tx, kidney cancer through TLX250-Tx and glioblastoma through TLX101-Tx. The company also entered a strategic collaboration with Regeneron, receiving an upfront payment of US$40.00 million to support the development of next-generation radiopharmaceutical therapies. With commercial products gaining traction, FDA-approved imaging technology and an expanding therapeutic pipeline, Telix’s next growth phase will depend on successful product launches, regulatory progress and continued global adoption of its radiopharmaceutical platform.

Note- All data presented is based on information available at the time of writing.

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