Shield Therapeutics gets FDA priority review to extend Accrufer indication

Shield Therapeutics said on Thursday that the US Food and Drug Administration (FDA) has granted priority review to extend the indication of its oral iron therapy Accrufer/Feraccru to adolescents aged 10 and above, with potential approval expected in 2026.

Shield Therapeutics
04 September 2025 14:01:50

Source: Sharecast

The AIM-traded firm said the application followed positive results from the company’s phase three paediatric trial, which confirmed the efficacy, safety and tolerability of a new oral liquid formulation in children with iron deficiency anaemia.

Shield submitted the clinical supplement in June, with the FDA granting priority review based on the final agreed study report.

The company said it also planned to seek approval to extend use of ferric maltol to children as young as one month through a new drug application for the liquid suspension used in the trial.

Shield said the formulation could also benefit adults who are unable to swallow capsules.

In Europe, its licensing partner Norgine had submitted a parallel application to the EMA for adolescent use, with a decision also anticipated in 2026.

“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 Dr Jackie Mitchell, vice president of quality, regulatory affairs and clinical development at Shield.

At 1335 BST, shares in Shield Therapeutics were up 33.97% at 8.44p.

Reporting by Josh White for Sharecast.com.

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