REG - Shield Therapeutics - FDA Grants additional Exclusivity for ACCRUFeR

Shield TherapeuticsAnnouncement

Mon 07:00

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RNS Number : 2151S  Shield Therapeutics PLC  09 February 2026

Shield Therapeutics plc

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

 

US FDA Grants additional 3 Years Exclusivity for ACCRUFeR®

 

London, UK, 09 February 2026: Shield Therapeutics plc (LSE: STX), a
commercial-stage pharmaceutical company specialising in iron deficiency,
announces that the US Food and Drug Administration (FDA) has granted to Shield
an additional 3 years of Data Exclusivity for ACCRUFeR® (ferric maltol). This
is due to the new clinical investigation conducted by Shield that was
essential to the approval of the extension of the indication to include
pediatric patients 10 years of age and older.  This exclusivity remains in
place until 19 December 2028 in addition to the ACCRUFeR®/FeRACCRU® patent
coverage valid until the mid-2030s.

 

The indication expansion was supported by 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 aged 1 month and above with iron deficiency, presenting as iron
deficiency anemia (IDA).

 

Dr Jackie Mitchell, VP of Regulatory, Quality, Clinical and Regulatory Affairs
of Shield, commented: "This exclusivity is a significant milestone for Shield
and recognises the value of the essential clinical investigation conducted to
support the pediatric indication, reflecting the strength of the Phase 3
FORTIS trial. We are well positioned to continue expanding access to
ACCRUFeR® and addressing unmet needs in both adult and pediatric
populations."

 

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/PZopny
 (https://shieldtherapeutics.com/link/PZopny)

 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 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 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. 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, 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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