AFT Pharmaceuticals iron project targets US$7.41B

• The US Food and Drug Administration cleared the injectable iron project of AFT Pharmaceuticals to proceed to a Phase 3 clinical trial.
• Following the regulatory clearance, the company's share price remained unchanged at $3.01.
• The global study aims to access an addressable market estimated by the company at US$7.41 billion.

AFT Pharmaceuticals (ASX:AFP) secured US Food and Drug Administration approval to launch a Phase 3 trial targeting a US$7.41 billion market.

The company's investigational new drug application successfully passed regulatory review.

The company stated that the global confirmatory study will involve 1,366 patients across multiple international jurisdictions.

The international trial locations are planned to include New Zealand, China, India, Japan, Armenia, Europe, and the US.

Following the announcement, the AFT Pharmaceuticals share price was unchanged at $3.01.

The business previously stated that it intends to increase its total research and development expenditure to $25 million in FY27.

The expansion follows a record operating profit of $24.4 million reported by the company for the 2026 financial year.