Shield Therapeutics PLC (AIM:STX, OTCQB:SHIEF) shares climbed in Thursday's early trade after it announced that the US Food and Drug Administration has accepted its submission to extend the label for the Accrufer iron supplement to adolescents with iron deficiency anemia.
The FDA has granted priority review status, with a decision expected in 2026, Shield told investors.
It follows positive results from a Phase 3 trial that confirmed the efficacy, safety, and tolerability of a new oral liquid pediatric formulation in children. Shield said it also plans to seek approval for children aged one month and older with a further submission.
"We are delighted to be able to progress a further significant expansion of the patient population to adolescents, who can benefit from a much needed safe and effective oral iron treatment," said Shield vice president Dr Jackie Mitchell.
Shield’s partner Norgine BV has also filed a regulatory submission with the European Medicines Agency for adolescent use, with approval also anticipated in 2026.
In London, Shield shares were up 12% changing hands at 7.06p.