Shield Thera Share News (STX)

(Alliance News) - Shield Therapeutics PLC on Thursday reported progress toward expanding the patient population for its oral treatment for those with iron deficiency with or without anaemia.

The Newcastle, England-based commercial-stage pharmaceutical company said Accrufer/Feraccru has been accepted by the US Food & Drug Administration as a clinical supplement.

Further, it has assigned priority review to extend the drug's indication to include patients aged below 10.

Feraccru is commercialised in the UK and EU, while Accrufer is commercialised in the US.

Shares in Shield Therapeutics climbed 38% to 8.72 pence on Thursday morning in London.

Shield said it submitted a clinical supplement application to the FDA in June of this year following positive results in its phase three paediatric trial.

The company noted that approval is expected next year, subject to successful review.

Shield also noted plans for a further extension of the indication to children aged one month and older.

It added that its EU licensing partner, Norgine BV, filed a regulatory submission to the European Medicines Agency in the second quarter of this year for the approval of Feraccru in adolescents. Approval in this context is also expected in 2026, pending successful review.

"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 Jackie Mitchell, vice president of Quality, RA and Clinical Development at Shield Therapeutics.

By Christopher Ward, Alliance News reporter

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