Shield Therapeutics (LSE:STX) has announced the publication of results from its Phase 3 FORTIS pediatric trial of ferric maltol in the journal Pediatric Drugs, providing further evidence supporting the treatment of iron deficiency anemia in children. The study demonstrated that ferric maltol significantly improved both hemoglobin levels and iron stores within 12 weeks in patients as young as one month old. Researchers also found that the treatment appeared to offer improved tolerability and palatability compared with conventional ferrous sulfate therapy.
The trial delivered clinically and statistically significant improvements in hemoglobin across all treatment groups. Children receiving ferric maltol experienced no treatment discontinuations due to adverse events, while treatment-related side effects occurred less frequently than in those treated with ferrous sulfate. The published findings strengthen Shield Therapeutics’ strategy to seek regulatory approval for a liquid formulation of ferric maltol for children aged two years and older. If approved, the expanded indication would broaden the potential use of ACCRUFeR/FeRACCRU in the pediatric market and enhance the company’s position within the growing iron deficiency treatment sector.
The company’s outlook continues to be influenced by financial challenges. Although operational progress has improved, Shield Therapeutics remains loss-making, with ongoing cash burn and negative shareholder equity. Technical indicators also remain weak, with the share price continuing to trade in a downward trend despite appearing oversold. Valuation offers only limited support, as the negative price-to-earnings ratio reflects the company’s current losses and there is no dividend yield.
About Shield Therapeutics
Shield Therapeutics is a commercial-stage specialty pharmaceutical company focused on the treatment of iron deficiency and iron deficiency anemia through its novel oral iron therapy ACCRUFeR/FeRACCRU (ferric maltol). The company markets the product in the United States and several international markets through commercial partnerships, targeting both adult and pediatric patients. Its intellectual property portfolio provides patent protection extending into the mid-2030s.
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