Shield Therapeutics (LSE:STX) has been granted a further three years of U.S. FDA data exclusivity for its oral iron therapy ACCRUFeR, extending regulatory protection through to 19 December 2028, in addition to existing patent coverage that runs into the mid-2030s. The exclusivity extension follows a new clinical investigation that supported expanding ACCRUFeR’s approved use to include pediatric patients aged 10 years and above, strengthening the product’s competitive protection in the U.S. market.
The broader pediatric indication is supported by positive Phase 3 FORTIS trial results, which demonstrated the efficacy, safety and tolerability of a new oral liquid formulation in children as young as one month with iron deficiency anaemia. According to the company, this regulatory milestone enhances the commercial potential of ACCRUFeR across both adult and pediatric populations, reinforcing its positioning within the growing iron deficiency treatment market and supporting international expansion plans.
From a market perspective, Shield’s outlook benefits from strong technical momentum in the shares and a series of supportive corporate developments. These positives are balanced against ongoing financial challenges and valuation concerns, with financial stability remaining a key risk factor despite the strengthening regulatory and commercial profile of the product.
More about Shield Therapeutics
Shield Therapeutics is a commercial-stage specialty pharmaceutical company focused on the treatment of iron deficiency and iron deficiency anaemia. Its lead product, ferric maltol, is marketed as ACCRUFeR in the United States and as FeRACCRU in other regions. Through partnerships with Viatris and a network of international licensees, the company is targeting a large and growing global market for iron deficiency therapies.
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