Aankondiging • Apr 28
MEDLEAP Pharma Confirms Enrollment in Phase II Clinical Trial for Accrufer in Japan Shield Therapeutics plc announced that its partner, MEDLEAP Pharma, a subsidiary of Vital KSK Holdings Inc. has confirmed its first patient enrollment for the Phase II clinical trial for ACCRUFeR (ferric maltol), a new drug candidate for Pulmonary Arterial Hypertension (PAH), for patients in Japan. This clinical trial is an exploratory study intended to support a planned Phase III trial. It follows the Pharmaceuticals and Medical Devices Agency's (PMDA) confirmation of the development plan for the drug as a PAH treatment in Japan, based on the drug's prior clinical results from trials in Europe, the UK, and the USA. Trial Details: Trial Name: An Exploratory Phase II Study to Evaluate the Efficacy and Safety of Ferric Maltol in Patients with Pulmonary Arterial Hypertension. Target Disease: Pulmonary Arterial Hypertension. Trial Location: Japan. 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 and www.feraccru.com. PAH (Pulmonary Arterial Hypertension) market in 2024 is estimated to be worth over $230M in Japan. Iron supplementation is strongly recommended for PAH patients with iron deficiency anemia according to both European and Japanese guidance (ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension 2022 and Japan Pulmonary Hypertension and Pulmonary Circulation Society Guidance 2024) [Recommendation Class I]. (1) Humbert M, et al. 2022 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension. Eur Respir J. 2023; 61(1):2200879. (2) Japanese Pulmonary Hypertension and Pulmonary Circulation Society. Pulmonary Hypertension Treatment Guidance 2024. Aankondiging • Apr 11
Shield Therapeutics plc, Annual General Meeting, Jun 18, 2026 Shield Therapeutics plc, Annual General Meeting, Jun 18, 2026. Location: the offices of shield therapeutics plc, northern design centre, baltic business quarter, gateshead quays, england, ne8 3df, United Kingdom Aankondiging • Apr 02
Shield Therapeutics plc Announces European Medicines Agency Approves Extension of Indication for FeRACCRU to Include Adolescents Shield Therapeutics plc announced that the European Medicines Agency (EMA) have published the CHMP meeting highlights in which they confirm their adoption of a positive opinion for the extension of the indication for FeRACCRU (ferric maltol) to include adolescents. FeRACCRU will now be indicated for the treatment of iron deficiency in adult and pediatric patients 12 years of age and older. EMA have also confirmed that all measures in the agreed Pediatric Investigation Plan (PIP) for FeRACCRU have been fulfilled. 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). Shield's licensing partner, Norgine B.V. holds the marketing authorisation and is responsible for commercialising FeRACCRU in the European Union. Shield will receive a milestone payment of EUR 500,000 from Norgine related to this EMA approval for the term of the agreement. 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 and www.feraccru.com. 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 month 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. Aankondiging • Mar 05
Shield Therapeutics Plc Announces Chinese NMPA Accepts MAA Submission For ACCRUFeR Shield Therapeutics plc announced the filing, and acceptance by the Chinese National Medical Products Administration ('NMPA'), of a Marketing Authorisation Application ('MAA') for ACCRUFeR for the treatment of adults with Iron Deficiency by its licensing partner, Beijing Aosaikang Pharmaceutical Co. Ltd. ('ASK Pharm'). The MAA is supported by the data Package used to obtain USA FDA approval for ACCRUFeR for the treatment of iron deficiency in adults, supplemented by Phase 3 data confirming the effectiveness of ACCRUFeR in an adult Chinese population. This follows the successful completion and outcome of a Phase 3 efficacy and safety clinical study in Chinese adults with iron deficiency anemia ('IDA') and inflammatory bowel disease who are intolerant to oral ferrous products. The study demonstrated clinically and statistically relevant efficacy and good tolerance in Chinese adults. 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. China's iron deficiency anemia (IDA) therapy market is growing rapidly, projected to double from around $280 million in 2022 to over $600 million by 2030. This growth is driven by increased healthcare access, government initiatives, and rising awareness. High-risk groups include women of reproductive age, pregnant women, and children-particularly in central-south and western regions. ACCRUFeR/FeRACCRU has patent coverage until the mid-2030s. ACCRUFeR/FeRACCRU are registered trademarks of Shield Therapeutics. The double-blind placebo-controlled randomized Phase 3 study included adults with mild to moderate iron-deficiency anemia (IDA) and Inflammatory Bowel Disease (IBD) who are intolerant to oral ferrous product, and who also had serum ferritin levels below 100 µg/L and transferrin saturation below 20%. Subjects were randomized 1:1 to receive either ferric maltol (N=60) or placebo (N = 61) bid for 12 weeks. Aankondiging • Feb 18
Shield Therapeutics plc Announces U.S. Food and Drug Administration Approval of ACCRUFeR Shield Therapeutics plc announced that ACCRUFeR (ferric maltol) is the first and only prescription oral iron treatment approved by the U.S. Food and Drug Administration for the treatment of iron deficiency in children age 10 and older. ACCRUFeR has been FDA-approved and prescribed for adults with iron deficiency since 2019. Iron deficiency affects about 2.4 million children in the United States, with adolescents at a particularly high risk. Up to 40% of females age 12-21 may be affected due to periodation and increased iron needs during period. Other common risk factors include not eating enough iron-rich foods, high-intensity athletic training, obesity, and growth spurts. Early treatment of iron deficiency in children is critical. Un unnoticed or untreated iron deficiency can lead to developmental delays, difficulty with learning and concentration, decreased academic performance, behavioral issues, and a weakened immune system. Common signs of low iron in children include unusual fatigue, paleness, irritability, or difficulty keeping up in school or activities. If parents have concerns surrounding iron deficiency they should speak with their child's doctor who may recommend performing blood tests to diagnose iron deficiency or iron deficiency anemia. Many families have experienced challenges with traditional iron supplements, which can cause stomach upset, nausea, or constipation - side effects that make it difficult for children to stick with treatment. ACCRUFeR®? was designed with tolerability in mind. For children ages 10 and up, ACCRUFeRACCRU®? is a new option that can help restore iron levels while minimizing the risk of GI side effects. Aankondiging • Feb 11
Shield Therapeutics plc Announces FDA Grants Additional 3 Years Exclusivity for ACCRUFeR Shield Therapeutics plc announced 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). Aankondiging • Nov 11
Shield Therapeutics plc Announces the Presentation of Accrufer Pediatric Pharmacokinetic (Pk) Study Shield Therapeutics plc announced the presentation (Abstract/Video and in person Poster) of a PK study (conducted as a sub-study of the positive FORTIS efficacy, tolerability and palatability pediatric ferric maltol clinical trial) at the American Society of Hematology (ASH) National Conference on 06 December 2025 in Orlando, Florida. Key Results: The PK profile in children and adolescents demonstrated ferric maltol's suitability for iron replacement in all age groups; Iron was well-absorbed at the age-appropriate doses used in the Phase 3 study; Maltol was rapidly metabolised and excreted in the urine with no accumulation in any age group; First data that confirms maltol metabolism and rapid excretion in the urine in infants 1 month to less than 2 years. The FORTIS study, including the PK data, is pivotal in supporting the Clinical Supplement assigned Priority Review by the US FDA to extend the indication for ACCRUFeR®? to include adolescents aged 10 years and above. Aankondiging • Nov 09
Shield Therapeutics plc Receives Marketing Authorisation by Korean Ministry of Food and Drug Safety Shield Therapeutics plc announced that the Korean Ministry of Food and Drug Safety (MFDS) has granted regulatory approval for ACCRUFeR (Ferric Maltol) in the Republic of Korea (South Korea) for the treatment of iron deficiency in adult subjects. This approval is an important milestone and follows the successful completion of a pharmacokinetic (PK) study which confirmed that the absorption of iron from ACCRUFeR was comparable between patients in South Korea and the patient population enrolled in the key clinical studies supporting ACCRU FeR®? effectiveness and safety and the subsequent submission of a New Drug Application (NDA) by Korea Pharma ("KP") in 2024. This approval marks a significant step forward in expanding access to ACCRUFeR for patients in South Korea suffering from iron deficiency. Shield is eligible to receive payments upon the first sale, as well as performance-based sales milestones and royalties on net sales of ACCRUFeR of South Korea. Aankondiging • Sep 15
Shield Therapeutics plc has completed a Follow-on Equity Offering in the amount of £1.5 million. Shield Therapeutics plc has completed a Follow-on Equity Offering in the amount of £1.5 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 20,000,000
Price\Range: £0.075
Transaction Features: Subsequent Direct Listing Aankondiging • Sep 04
Shield Therapeutics plc Announces ACCRUFeR® Assigned Priority Review in US by FDA Shield Therapeutics plc announced 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 current capsule formulation. Shield's licensing partner in the EU, Norgine B.V., also filed a regulatory submission to the EMA in Second Quarter 2025 for the approval of FeRACCRU® (ferric maltol) in the adolescent population. Pending successful review, approval is also anticipated in 2026. Aankondiging • Aug 28
Shield Therapeutics plc Announces Positive Efficacy and Safety Results in the Orion-Hf Study Shield Therapeutics plc announced positive efficacy and safety results in the ORION-HF study showing improvements in haemoglobin and other iron markers, exercise capacity, and quality of life (QoL) in patients with heart failure (HF) and iron deficiency anemia (IDA), after 16 weeks of treatment with FeRACCRU®? (ferric maltol). These results were published in the European Journal of Heart Failure on 21 July 2025. The ORION-HF study was a multicenter, European, open-label, prospective clinical study, to investigate the impact of orally formulated ferric maltol (30 mg bid) in 50 patients with symptomatic HF and IDA. Positive and clinically meaningful efficacy and safety results were achieved in the study: Significant increase in haemoglobin (Hb) concentration (Primary endpoint): Oral ferric maltol treatment resulted in significantly increased haemoglobin (from 11.4 [10.9-11.9] to 12.8 [11.8-13.8] g/dl) from baseline to week 16 (p<0.001). Statistically significant differences from baseline to week 16 in 6-minute walk test (6MW) (p<0.001) and Quality of Life scores (p=0.004) o Oral ferric maltol treatment resulting in significant increase in distance walk in 6MW test (from 298 [220-405] to 335 [255-430] meters). Oral ferric maltol treatment result in a significant increase in the Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score (from 65 [44-82] to 76 [55-86] score points). Statistically significant differences from base to week 16 in Other Iron Markers (ferritin, iron, transferrin saturation) (p<0.1). Ferric maltol was well-tolerated with no serious related adverse events reported o Adverse event profiles were consistent with previous Phase 3 studies. o AEs (N=19) were mainly GI related. These positive results published in the European Journal of heart failure - Kempf - European Journal of Heart Failure - Wiley Online Library,) are consistent with results reported from an earlier study in patients with pulmonary hypertension (PH) and anemia published in the European Respiratory Society (Oral iron supplementation with ferric maltol in patients with pulmonary hypertension | European Respiratory Society). Shield's licensing partner in Japan (VITAL-NET Inc. (VITAL-NET)) has recently had an IND approved to further investigate the impact of ferric maltol treatment in Japanese patients with PH and anemia in Japan. Aankondiging • Mar 12
Shield Therapeutics plc Launches ACCRUFeR in Partnership with Kye Pharmaceuticals, Inc Shield Therapeutics plc announced that it has launched ACCRUFeR® in Canada in partnership with its Canadian partner, Kye Pharmaceuticals Inc. ("Kye"). This follows approval in August 2024 from Health Canada for ACCRUFeR(r) (ferric maltol) as a prescription drug for the treatment of adults with iron deficiency anemia ("IDA"). ACCRUFeR® is currently the sole prescription-only oral treatment option indicated for IDA in Canada and is available by prescription through pharmacies across Canada. Shield will be responsible for all manufacturing and supply to the Canadian market. In accordance with the collaborative agreement Shield is eligible to receive further milestone payments upon the achievement of specified calendar net sales targets and will also receive double-digit royalties on net sales of ACCRUFeR®, for the term of agreement. Aankondiging • Dec 08
Shield Therapeutics plc has filed a Follow-on Equity Offering in the amount of £8.692308 million. Shield Therapeutics plc has filed a Follow-on Equity Offering in the amount of £8.692308 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 256,410,256
Price\Range: £0.03
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 33,333,333
Price\Range: £0.03
Transaction Features: Subsequent Direct Listing Aankondiging • Aug 27
Shield Therapeutics plc Announces Health Canada Approves ACCRUFeR as Prescription Drug for the Treatment of Adults with Iron Deficiency Anemia Shield Therapeutics plc announced that Health Canada has approved ACCRUFeR (ferric maltol) as a prescription drug for the treatment of adults with iron deficiency anemia. This development allows Shield's partner, Kye pharmaceuticals Inc., to launch ACCRUFeR in Canada. Shield will be responsible for all manufacturing and supply to the Canadian market. In accordance with the collaborative agreement, Shield is now due to receive a £250,000 milestone payment. For the remaining term of the agreement, Shield will receive additional revenue-based milestone payments along with double-digit royalties on net sales of ACCRUFeR. Aankondiging • Aug 14
Shield Therapeutics plc to Report First Half, 2024 Results on Sep 04, 2024 Shield Therapeutics plc announced that they will report first half, 2024 results on Sep 04, 2024 Aankondiging • Jul 24
Shield Therapeutics plc Announces CEO Changes Shield Therapeutics plc announced that Greg Madison, Chief Executive Officer, will be stepping down from the Board by mutual consent to pursue other opportunities and will be leaving the Company with immediate effect. Anders Lundstrom, one of the Company's independent non-executive Directors was appointed interim Chief Executive Officer. Anders, who is based in Boston, Massachusetts, has strong international and US senior commercial and general management experience gained from a range of pharmaceutical and biotech companies including AstraZeneca, Biogen and Orexo (where he was president and CEO). Aankondiging • Jul 03
Rudolf Widmann Joins Board of Shield Therapeutics plc as Non-Executive Director Shield Therapeutics plc announced that AOP's founder, Dr. Rudolf Widmann, will join the Shield Board as a Non-Executive Director, effective immediately. Dr. Rudolf Widmann is an experienced pharmaceutical scientist, seasoned executive and entrepreneur who has devoted his career to advancing the care of patients with rare diseases. He foundedAOP Health (AOP Orphan Pharmaceuticals GmbH)in 1996, starting as Chief Executive Officer and Chief Therapeutics Development Officer and later elected to serve as a governing Board Member of the AOP Health Group. Dr. Widmann holds a degree in pharmacy studies and a PhD in pharmacology from the University of Innsbruck. Shield also discloses the following information in accordance with Schedule 2(g) of the AIM Rules for Companies. Full name: Dr. Rudolf Stefan Widmann. Age: 67 years. Current directorships/partnerships: AOP Health International Management AG and Wirucon GmbH. Previous directorships/partnerships held in the past 5 years: AOP Orphan Limited, Irorph GmbH, Orphanidis Pharma Research GmbH, and OrphaCare GmbH. Dr. Widmann does not hold any ordinary shares in Shield. Aankondiging • May 15
Shield Therapeutics plc, Annual General Meeting, Jun 20, 2024 Shield Therapeutics plc, Annual General Meeting, Jun 20, 2024. Location: the offices of shield therapeutics plc, northern design centre, baltic business quarter, ne8 3df, gateshead quays United Kingdom Aankondiging • May 01
Shield Therapeutics plc to Report Fiscal Year 2023 Final Results on May 10, 2024 Shield Therapeutics plc announced that they will report fiscal year 2023 final results on May 10, 2024 Aankondiging • Apr 16
Shield Therapeutics plc to Report Fiscal Year 2023 Final Results on Apr 30, 2024 Shield Therapeutics plc announced that they will report fiscal year 2023 final results on Apr 30, 2024 Aankondiging • Jan 10
Shield Therapeutics Appoints Santosh Shanbhag as New CFO, Effective January 16, 2024 Shield Therapeutics plc appointed Santosh Shanbhag as Chief Financial Officer, effective January 16, 2024. The company's previous finance chief Hans-Peter Rudolf had stepped down from the post in October to pursue other opportunities. Before joining Shield, Shanbhag, with more than 20 years of experience in leading finance roles, was workingwith Akili Inc. as CFO. Aankondiging • Oct 12
Shield Therapeutics plc Announces Hans-Peter Rudolf Is Standing Down from His Role as Chief Financial Officer on 20 October 2023 Shield Therapeutics plc announces that Hans-Peter Rudolf is standing down from his role as Chief Financial Officer ("CFO") of the Group to pursue other opportunities. Hans-Peter will step down from this role as of 20 October 2023, and is available for consulting through to the end of the month. His resignation is not the result of any dispute or disagreement with Shield on any matters relating to Shield's financial statements, internal controls, operations, policies or practices. Shield also announces that Paul Spoors, Group Company Controller since 2019, will assume additional responsibility and report directly to the Shield's Chief Executive Officer, Greg Madison, on an interim basis. The Company has hired an executive search firm to identify a new Chief Financial Officer and a further announcement relating to this appointment will be made in due course. Aankondiging • Oct 05
Shield Therapeutics plc has completed a Follow-on Equity Offering in the amount of £5.109782 million. Shield Therapeutics plc has completed a Follow-on Equity Offering in the amount of £5.109782 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 41,380,508
Price\Range: £0.08
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 21,012,552
Price\Range: £0.08
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 1,479,211
Price\Range: £0.08
Transaction Features: Regulation S; Subsequent Direct Listing Aankondiging • Sep 29
Shield Therapeutics plc has completed a Follow-on Equity Offering in the amount of £4.991445 million. Shield Therapeutics plc has completed a Follow-on Equity Offering in the amount of £4.991445 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 41,380,508
Price\Range: £0.08
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 21,012,552
Price\Range: £0.08
Transaction Features: Regulation S; Subsequent Direct Listing Aankondiging • Sep 08
Shield Therapeutics plc to Report First Half, 2023 Results on Sep 28, 2023 Shield Therapeutics plc announced that they will report first half, 2023 results on Sep 28, 2023 Aankondiging • May 20
Shield Therapeutics plc, Annual General Meeting, Jun 28, 2023 Shield Therapeutics plc, Annual General Meeting, Jun 28, 2023, at 13:00 Coordinated Universal Time. Location: Northern Design Centre, Baltic Business Quarter, Gateshead Quays, England NE8 3DF England United Kingdom