Breakeven Date Change • Aug 20 The 3 analysts covering Shield Therapeutics previously expected the company to break even in 2027. New consensus forecast suggests losses will reduce by 99% to 2026. The company is expected to make a profit of US$10.7m in 2027. Average annual earnings growth of 81% is required to achieve expected profit on schedule.
공고 • Aug 01
Shield Therapeutics plc Appoints Michael Jensen as Chief Financial Officer, Effective 1 September 2026 Shield Therapeutics plc announced appointment of Michael Jensen as new Chief Financial Officer, effective 1 September 2026. Michael brings more than 20 years of executive financial leadership experience across the biopharmaceutical, medical device, and healthcare sectors, with a strong track record of driving financial and operational transformation in both public and venture capital-backed organisations, supporting commercial growth, strengthening financial performance, and creating shareholder value. Michael joins Shield from StimLabs, where he served as Chief Financial Officer, and previously held CFO positions at Synlogic and Intrinsic Therapeutics. Earlier in his career, he held senior finance leadership roles at Novo Nordisk, Novartis, and Siemens Healthcare Diagnostics. Michael holds a Master's degree from Copenhagen Business School, including studies in the MBA program at Duke University's Fuqua School of Business, and an undergraduate degree from Towson University, Maryland. 공고 • Jul 28
Shield Therapeutics Publishes ACCRUFeR Phase 3 Pediatric Trial Results In Pediatric Drugs Shield Therapeutics plc announced the publication of the positive efficacy, tolerability and palatability results from the ferric maltol pediatric FORTIS clinical trial, comparing the safety and efficacy of ferric maltol and ferrous sulfate for iron deficiency anemia (IDA), in Pediatric Drugs. Ferric maltol significantly improved Hb levels and iron storage within 12 weeks in children aged 1 month and above, offering potentially better tolerability and palatability compared with ferrous sulfate in children and adolescents. Clinically and statistically significant Hb improvements vs. baseline were observed across all groups (ferric maltol arms and ferrous sulfate arm (P<0.0001). No patient discontinued ferric maltol treatment due to an adverse event compared to one patient who discontinued from the ferrous sulfate arm. Treatment related adverse events (AEs) were reported in 6.5% of patients treated with ferric maltol and 13% of patients treated with ferrous sulphate. No treatment related serious AEs (SAEs) were reported in either group. The capsule formulation (30mg) of Ferric Maltol is approved for treatment of adolescents and adults aged 10 years and above (ACCRUFeR) in the USA and 12 years and above (FeRACCRU) in the EU. Registration of the liquid formulation used in the trial is planned to support the treatment of younger children aged 2 and above. 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. ACCRUFeR/FeRACCRU has patent coverage until the mid-2030s. ACCRUFeR/FeRACCRU are registered trademarks of Shield Therapeutics. 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. 공고 • 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. 공고 • 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 공고 • 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. 
