REG - Shield Therapeutics - ACCRUFeR® assigned Priority Review in US by FDA

Shield TherapeuticsAnnouncement

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RNS Number : 9329X  Shield Therapeutics PLC  04 September 2025

Shield Therapeutics plc

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

 

ACCRUFeR® assigned Priority Review in the US by FDA in children with iron
deficiency anemia (IDA)

 

Pending successful review, approval in the US is anticipated in 2026

 

 

London, UK, September 4, 2025: Shield Therapeutics plc (LSE: STX), a
commercial-stage pharmaceutical company specialising in iron deficiency,
announces that the US Food and Drug Administration (FDA) has accepted
ACCRUFeR®/FeRACCRU® (ferric maltol) as a Clinical Supplement and assigned
Priority Review to extend the indication for ACCRUFeR®/FeRACCRU®  to
include adolescents aged 10 years and above.

 

Following the positive results from the Phase 3 pediatric clinical trial
(FORTIS/ST10-01-305) that confirmed the efficacy, safety, and tolerability of
the new oral liquid pediatric formulation in children with (IDA), Shield
submitted a clinical supplement application to the FDA in June 2025 for the
approval of ACCRUFeR®/FeRACCRU® in the pediatric population. FDA has granted
Priority Review for the supplement as it supports the extension of the label
to a pediatric population based on a final agreed pediatric study report.
Pending successful review, approval is anticipated in 2026.

 

Shield plans to file for a further extension of the indication to include
children 1 month and above in conjunction with the submission of an NDA for a
new pediatric formulation (ferric maltol suspension) which was used in the
successful FORTIS Phase 3 study in this population. If approved, this
formulation may also offer an alternative approach for adults who can't
swallow our current capsule formulation.

 

Shield's licensing partner in the EU, Norgine B.V., also filed a regulatory
submission to the EMA in Q2 2025 for the approval of FeRACCRU® (ferric
maltol) in the adolescent population. Pending successful review, approval is
also anticipated in 2026.

 

 

Dr Jackie Mitchell, VP of Quality, RA and Clinical Development at Shield,
commented: "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."

 

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

 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.

 

ACCRUFeR®/FeRACCRU® (ferric maltol) is a novel, stable, non-salt-based oral
therapy for adults with ID/IDA. 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. 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., which also has
marketing rights in Australia and New Zealand. 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,
with Kye Pharmaceuticals Inc. for Canada, and with VITAL-NET 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, including secondary endpoints and pharmacokinetic (PK)
sub-study parameters, will be 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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