FDA Grants additional Exclusivity for ACCRUFeR

London, UK, 09 February 2026: Shield Therapeutics plc (LSE: STX), a commercial-stage pharmaceutical company specialising in iron deficiency, announces that the US Food and Drug Administration (FDA) has granted to Shield an additional 3 years of Data Exclusivity for ACCRUFeR® (ferric maltol). This is due to the new clinical investigation conducted by Shield that was essential to the approval of the extension of the indication to include pediatric patients 10 years of age and older. This exclusivity remains in place until 19 December 2028 in addition to the ACCRUFeR®/FeRACCRU® patent coverage valid until the mid-2030s.

The indication expansion was supported by positive results from the Phase 3 pediatric clinical trial (FORTIS/ST10-01-305) that confirmed the efficacy, safety, and tolerability of the new oral liquid pediatric formulation in children aged 1 month and above with iron deficiency, presenting as iron deficiency anemia (IDA).

Dr Jackie Mitchell, VP of Regulatory, Quality, Clinical and Regulatory Affairs of Shield, commented: "This exclusivity is a significant milestone for Shield and recognises the value of the essential clinical investigation conducted to support the pediatric indication, reflecting the strength of the Phase 3 FORTIS trial. We are well positioned to continue expanding access to ACCRUFeR® and addressing unmet needs in both adult and pediatric populations."

Clinically low iron levels (aka iron deficiency, ID) can cause serious health problems for adults of all ages, across multiple therapeutic areas. Together, ID and ID with anemia (IDA) affect about 20 million people in the US and represent a $2.3B market opportunity. As the first and only FDA approved oral iron to treat ID/IDA, ACCRUFeR® has the potential to meet an important unmet medical need for both physicians and patients and is now the #1 branded prescription oral iron the market today (*data source - IQVIA Xponent PlanTrak).

Details of the FORTIS/ST10-01-305 Phase 3 study

(N = 30). Children 1 months to under 2 years (N=4) were all assigned to receive ferric maltol treatment. The full data sets, including secondary endpoints and pharmacokinetic (PK) sub-study parameters, will be submitted for peer-review and subsequent presentation/publication. The trial is the final study in the comprehensive pediatric development program that Shield committed to implement with both the European EMA and the US FDA.