AFT Pharmaceuticals (NZE:AFT, ASX:AFP) said the US Food and Drug Administration allowed the company to proceed with a phase 3 clinical trial of its injectable iron deficiency therapy, according to a Wednesday filing with the Australian and New Zealand bourses.
AFT and development partner Hyloris Pharmaceuticals plan to launch a global confirmatory study involving 1,366 patients across multiple geographies including New Zealand, China, India, Japan, Armenia, Europe, and the US.
The therapy targets an addressable market estimated at $7.41 billion, per the filing.
The company's New Zealand shares gained 2% in recent Wednesday trade.