RCS - Shield Therapeutics - Publication of Report, Reinforcing FDA Approval

Shield TherapeuticsAnnouncement

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RNS Number : 0432Z  Shield Therapeutics PLC  01 April 2026

Shield Therapeutics plc

("Shield" or the "Company" or the "Group")

 

Publication of Report in Pediatric Drugs, Reinforcing FDA Approval Milestone

 

London, UK, 01 April 2026: Shield Therapeutics plc (LSE: STX), a
commercial-stage pharmaceutical company specialising in iron deficiency,
announces that an independent peer-reviewed AdisInsight Report on
ACCRUFeR®/FeRACCRU®  (ferric maltol) has been published online
in Pediatric Drugs, a leading international journal for healthcare
professionals.

 

This report, titled Ferric Maltol: Pediatric First Approval, is available via
the following link:
https://link.springer.com/article/10.1007/s40272-026-00748-3
(https://link.springer.com/article/10.1007/s40272-026-00748-3)

 

The publication reports on the recent US Food and Drug Administration (FDA)
approval of the extension of the ferric maltol indication to include pediatric
patients aged 10 years and over for the treatment of iron deficiency, which
was supported by positive results from the Phase 3 pediatric clinical trial
(FORTIS/ST10-01-305) that confirmed the efficacy, safety, and tolerability of
a new oral liquid pediatric formulation in children aged 1 month and above
with iron deficiency, presenting as iron deficiency anemia (IDA).

 

Anders Lundstrom, CEO of Shield, commented: "Iron deficiency in children is a
serious and often underdiagnosed condition, and today's publication in
Pediatric Drugs underscores the clinical importance of having an approved,
well-characterised treatment option for pediatric patients. The FDA's decision
to extend the ferric maltol indication to patients aged 10 and over is a
significant step forward, and we are committed to ensuring that both
clinicians and patients can benefit from this approval as quickly as
possible."

 

For further information please contact:

 

 Shield Therapeutics plc                                                                        www.shieldtherapeutics.com (http://www.shieldtherapeutics.com/)
 Anders Lundstrom, CEO                                                                          +44 (0) 191 511 8500

 Santosh Shanbhag, CFO                                                                          Investorrelations@shieldtx.com

 Stephanie Hicks, Investor Relations
 https://shieldtherapeutics.com/link/Pd6j7e
 (https://shieldtherapeutics.com/link/Pd6j7e)

 Nominated Adviser and Joint Broker
 Peel Hunt LLP
 James Steel                                                                                    +44 (0)20 7418 8900

 Joint Broker

 Cavendish Ltd

 Geoff Nash/ Isaac Hooper/Nigel Birks/Harriet
 Ward

                                                                                                +44 (0)20 7220 0500

 

 

About Iron Deficiency and ACCRUFeR®/FeRACCRU®

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).

 

ACCRUFeR®/FeRACCRU® (ferric maltol) is a novel, stable, non-salt-based oral
therapy for patients suffering from iron deficiency, with or without anemia..
The drug has a novel mechanism of absorption compared to other oral iron
therapies and has been shown to be an efficacious and well-tolerated therapy
in a range of clinical trials. More information about ACCRUFeR®/FeRACCRU®,
including the product label, can be found at: www.accrufer.com
(http://www.accrufer.com) and www.feraccru.com (http://www.feraccru.com) .

 

 

About Shield Therapeutics plc

Shield is a commercial stage specialty pharmaceutical company that delivers
ACCRUFeR®/FeRACCRU® (ferric maltol), an innovative and differentiated
pharmaceutical product, to address a significant unmet need for patients
suffering from iron deficiency, with or without anemia. The Company has
launched ACCRUFeR® in the U.S. to include pediatric patients 10 years of age
and older with an exclusive, multi-year collaboration agreement with Viatris.
Outside of the U.S., the Company has licensed the rights to five specialty
pharmaceutical companies. FeRACCRU® is commercialised in the UK and European
Union by Norgine B.V., to include pediatric patients 12 years of age and older
and also have marketing rights in Australia and New Zealand. FeRACCRU® is
also commercialised in Canada by Kye Pharmaceuticals Inc. Shield also has an
exclusive license agreement with Beijing Aosaikang Pharmaceutical Co., Ltd.,
for the development and commercialisation of ACCRUFeR®/FeRACCRU® in China,
Hong Kong, Macau and Taiwan, with Korea Pharma Co., Ltd. for the Republic of
Korea, and with Medleap Pharma Company Limited, a subsidiary of VITAL-NET Inc.
for Japan.

 

ACCRUFeR®/FeRACCRU® has patent coverage until the mid-2030s.

ACCRUFeR®/FeRACCRU® are registered trademarks of Shield Therapeutics.

 

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

The open label randomized Phase 3 study included children aged 1 month to 17
years with mild to moderate IDA, who also had serum ferritin levels below 30
μg/L or ferritin levels below 50 μg/L and transferrin saturation below
20%.  Children aged 2 to 17 years were randomized 1:1 to receive either
ferric maltol (N=31) or ferrous sulphate

(N = 30).  Children 1 months to under 2 years (N=4) were all assigned to
receive ferric maltol treatment. The full data sets have been 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.

 

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