AFT Pharmaceuticals (ASX:AFP) has announced that the US Food and Drug Administration has reviewed and allowed the company’s Investigational New Drug application for its injectable iron project to proceed to a global Phase 3 clinical trial.
The study will enrol 1,366 patients across New Zealand, China, India, Japan, Armenia, Europe and the United States and is being advanced with development partner Hyloris Pharmaceuticals, a move the company says addresses an estimated US$7.41 billion market.
That regulatory clearance comes as AFT closes financial year 2026 with operating revenue of NZ$254.7 million, up 22 per cent, and operating profit of NZ$24.4 million.
The company reported double-digit product sales growth across territories, with Australia up 19 per cent, international sales up 66 per cent, and Asia up 41 per cent, while the dividend per share rose to 2.5 cents, up 39 per cent.
AFT highlighted a two-decade record of uninterrupted growth, showing a 20-year compound annual growth rate of 17 per cent and a clear path toward the NZ$300 million revenue target.
Global expansion remains central, with agreements in more than 100 countries, sales in 87 countries, and new market entries in the financial year 2026, including Taiwan and Egypt. Management says the UK and South Africa hubs are expected to contribute to earnings in the financial year 2027 as international launches scale.
The company highlights an active pipeline, including eight patented products, the progression of 24 plus off-patent injectables, multiple Maxigesic formulations, and licensed projects such as the intravenous iron program.
The company said it expects financial year operating profit between NZ$28 million and NZ$32 million. It emphasises continued expansion in Australasian markets, a program of international launches, ongoing R&D, and an active licensing and out-licensing program.
