Shield Therapeutics（SHIE.F）株式概要シールド・セラピューティクス社は、商業段階のスペシャリティ・ファーマであり、アンメット・メディカル・ニーズを治療する医薬品の商業化に注力している。 詳細SHIE.F ファンダメンタル分析スノーフレーク・スコア評価4/6将来の成長5/6過去の実績0/6財務の健全性1/6配当金0/6報酬当社が推定した公正価値より82.3%で取引されている 収益は年間109.79%増加すると予測されています リスク分析マイナスの株主資本 株式の流動性は非常に低い 意味のある時価総額がありません ( $91M )すべてのリスクチェックを見るSHIE.F Community Fair Values Create NarrativeSee what others think this stock is worth. Follow their fair value or set your own to get alerts.Your Fair ValueUS$Current PriceUS$0.09478.5% 割安 内在価値ディスカウントGrowth estimate overAnnual revenue growth rate5 Yearstime period%/yrDecreaseIncreasePastFuture-50m146m2016201920222025202620282031Revenue US$146.2mEarnings US$21.4mAdvancedSet Fair ValueView all narrativesShield Therapeutics plc 競合他社Verrica PharmaceuticalsSymbol: NasdaqCM:VRCAMarket cap: US$101.4mBioStem TechnologiesSymbol: OTCPK:BSEMMarket cap: US$69.5mRafael HoldingsSymbol: NYSE:RFLMarket cap: US$69.2mEarth Science TechSymbol: OTCPK:ETSTMarket cap: US$46.9m価格と性能株価の高値、安値、推移の概要Shield Therapeutics過去の株価現在の株価UK£0.09452週高値UK£0.1752週安値UK£0.033ベータ1.881ヶ月の変化-43.78%3ヶ月変化-33.19%1年変化n/a3年間の変化4.89%5年間の変化-88.01%IPOからの変化-92.57%最新ニュースお知らせ • Apr 28MEDLEAP Pharma Confirms Enrollment in Phase II Clinical Trial for Accrufer in JapanShield 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.お知らせ • Apr 11Shield Therapeutics plc, Annual General Meeting, Jun 18, 2026Shield 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お知らせ • Apr 02Shield Therapeutics plc Announces European Medicines Agency Approves Extension of Indication for FeRACCRU to Include AdolescentsShield 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.お知らせ • Mar 05Shield Therapeutics Plc Announces Chinese NMPA Accepts MAA Submission For ACCRUFeRShield 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.お知らせ • Feb 18Shield Therapeutics plc Announces U.S. Food and Drug Administration Approval of ACCRUFeRShield 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.お知らせ • Feb 11Shield Therapeutics plc Announces FDA Grants Additional 3 Years Exclusivity for ACCRUFeRShield 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).最新情報をもっと見るRecent updatesお知らせ • Apr 28MEDLEAP Pharma Confirms Enrollment in Phase II Clinical Trial for Accrufer in JapanShield 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.お知らせ • Apr 11Shield Therapeutics plc, Annual General Meeting, Jun 18, 2026Shield 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お知らせ • Apr 02Shield Therapeutics plc Announces European Medicines Agency Approves Extension of Indication for FeRACCRU to Include AdolescentsShield 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.お知らせ • Mar 05Shield Therapeutics Plc Announces Chinese NMPA Accepts MAA Submission For ACCRUFeRShield 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.お知らせ • Feb 18Shield Therapeutics plc Announces U.S. Food and Drug Administration Approval of ACCRUFeRShield 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.お知らせ • Feb 11Shield Therapeutics plc Announces FDA Grants Additional 3 Years Exclusivity for ACCRUFeRShield 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).お知らせ • Nov 11Shield Therapeutics plc Announces the Presentation of Accrufer Pediatric Pharmacokinetic (Pk) StudyShield 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.お知らせ • Nov 09Shield Therapeutics plc Receives Marketing Authorisation by Korean Ministry of Food and Drug SafetyShield 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.お知らせ • Sep 15Shield 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お知らせ • Sep 04Shield Therapeutics plc Announces ACCRUFeR® Assigned Priority Review in US by FDAShield 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.お知らせ • Aug 28Shield Therapeutics plc Announces Positive Efficacy and Safety Results in the Orion-Hf StudyShield 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.お知らせ • Mar 12Shield Therapeutics plc Launches ACCRUFeR in Partnership with Kye Pharmaceuticals, IncShield 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.お知らせ • Jan 27+ 1 more updateShield Therapeutics plc Announces Board ChangesShield Therapeutics plc announced that upon taking on the CEO role on a permanent basis Anders Lundstrom will step down from his position as Chair of the Remuneration Committee which position will be taken on by Dr. Christian Schweiger, one of the Company's non-executive Directors. Since Anders' appointment in July, his leadership has been instrumental in driving Shield's growth and operational efficiency. Under his guidance, the Company has experienced increases in revenues and net pricing for ACCRUFeR in the United States and fostered strengthened relationships with key partners and shareholders. These efforts have helped provide additional support to Shield's long-term strategic goals. Anders has also played a pivotal role in streamlining operations, positioning the Company for success as it works towards its goal of becoming cash flow positive by the end of 2025.お知らせ • Dec 08Shield 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お知らせ • Aug 27Shield Therapeutics plc Announces Health Canada Approves ACCRUFeR as Prescription Drug for the Treatment of Adults with Iron Deficiency AnemiaShield 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.お知らせ • Aug 14Shield Therapeutics plc to Report First Half, 2024 Results on Sep 04, 2024Shield Therapeutics plc announced that they will report first half, 2024 results on Sep 04, 2024お知らせ • Jul 24Shield Therapeutics plc Announces CEO ChangesShield 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).お知らせ • Jul 03Rudolf Widmann Joins Board of Shield Therapeutics plc as Non-Executive DirectorShield 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.お知らせ • May 15Shield Therapeutics plc, Annual General Meeting, Jun 20, 2024Shield 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お知らせ • May 01Shield Therapeutics plc to Report Fiscal Year 2023 Final Results on May 10, 2024Shield Therapeutics plc announced that they will report fiscal year 2023 final results on May 10, 2024お知らせ • Apr 16Shield Therapeutics plc to Report Fiscal Year 2023 Final Results on Apr 30, 2024Shield Therapeutics plc announced that they will report fiscal year 2023 final results on Apr 30, 2024お知らせ • Jan 10Shield Therapeutics Appoints Santosh Shanbhag as New CFO, Effective January 16, 2024Shield 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.お知らせ • Oct 12Shield Therapeutics plc Announces Hans-Peter Rudolf Is Standing Down from His Role as Chief Financial Officer on 20 October 2023Shield 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.お知らせ • Oct 05Shield 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お知らせ • Sep 29Shield 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お知らせ • Sep 08Shield Therapeutics plc to Report First Half, 2023 Results on Sep 28, 2023Shield Therapeutics plc announced that they will report first half, 2023 results on Sep 28, 2023お知らせ • May 20Shield Therapeutics plc, Annual General Meeting, Jun 28, 2023Shield 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株主還元SHIE.FUS PharmaceuticalsUS 市場7D-21.4%1.9%-0.8%1Yn/a41.8%27.1%株主還元を見る業界別リターン: SHIE.FがUS Pharmaceuticals業界に対してどのようなパフォーマンスを示したかを判断するにはデータが不十分です。リターン対市場: SHIE.F US市場に対してどのようなパフォーマンスを示したかを判断するにはデータが不十分です。価格変動Is SHIE.F's price volatile compared to industry and market?SHIE.F volatilitySHIE.F Average Weekly Movementn/aPharmaceuticals Industry Average Movement10.0%Market Average Movement7.2%10% most volatile stocks in US Market16.3%10% least volatile stocks in US Market3.2%安定した株価: SHIE.Fの株価は、 US市場と比較して過去 3 か月間で変動しています。時間の経過による変動: 過去 1 年間のSHIE.Fのボラティリティの変化を判断するには データが不十分です。会社概要設立従業員CEO（最高経営責任者ウェブサイト200863Anders Lundstromwww.shieldtherapeutics.comShield Therapeutics plcはコマーシャルステージのスペシャリティファーマで、アンメットメディカルニーズを満たす医薬品の商業化に注力している。主力製品はAccrufer/Feraccruで、貧血を伴う、あるいは伴わない鉄欠乏症を治療する成人向けの非塩ベースの経口療法である。Shield Therapeutics plcは2008年に設立され、英国ゲーツヘッドに本社を置いている。もっと見るShield Therapeutics plc 基礎のまとめShield Therapeutics の収益と売上を時価総額と比較するとどうか。SHIE.F 基礎統計学時価総額US$91.16m収益（TTM）-US$17.65m売上高(TTM)US$49.70m1.8xP/Sレシオ-5.2xPER（株価収益率SHIE.F は割高か？公正価値と評価分析を参照収益と収入最新の決算報告書（TTM）に基づく主な収益性統計SHIE.F 損益計算書（TTM）収益US$49.70m売上原価US$26.66m売上総利益US$23.04mその他の費用US$40.69m収益-US$17.65m直近の収益報告Dec 31, 2025次回決算日該当なし一株当たり利益（EPS）-0.017グロス・マージン46.36%純利益率-35.52%有利子負債／自己資本比率-199.9%SHIE.F の長期的なパフォーマンスは？過去の実績と比較を見るView Valuation企業分析と財務データの現状データ最終更新日（UTC時間）企業分析2026/05/21 23:39終値2026/05/21 00:00収益2025/12/31年間収益2025/12/31データソース企業分析に使用したデータはS&P Global Market Intelligence LLC のものです。本レポートを作成するための分析モデルでは、以下のデータを使用しています。データは正規化されているため、ソースが利用可能になるまでに時間がかかる場合があります。パッケージデータタイムフレーム米国ソース例会社財務10年損益計算書キャッシュ・フロー計算書貸借対照表SECフォーム10-KSECフォーム10-Qアナリストのコンセンサス予想+プラス3年予想財務アナリストの目標株価アナリストリサーチレポートBlue Matrix市場価格30年株価配当、分割、措置ICEマーケットデータSECフォームS-1所有権10年トップ株主インサイダー取引SECフォーム4SECフォーム13Dマネジメント10年リーダーシップ・チーム取締役会SECフォーム10-KSECフォームDEF 14A主な進展10年会社からのお知らせSECフォーム8-K* 米国証券を対象とした例であり、非米国証券については、同等の規制書式および情報源を使用。特に断りのない限り、すべての財務データは1年ごとの期間に基づいていますが、四半期ごとに更新されます。これは、TTM（Trailing Twelve Month）またはLTM（Last Twelve Month）データとして知られています。詳細はこちら。分析モデルとスノーフレーク本レポートを生成するために使用した分析モデルの詳細は当社のGithubページでご覧いただけます。また、レポートの使用方法に関するガイドやYoutubeのチュートリアルも掲載しています。シンプリー・ウォールストリート分析モデルを設計・構築した世界トップクラスのチームについてご紹介します。業界およびセクターの指標私たちの業界とセクションの指標は、Simply Wall Stによって6時間ごとに計算されます。アナリスト筋Shield Therapeutics plc 3 これらのアナリストのうち、弊社レポートのインプットとして使用した売上高または利益の予想を提出したのは、 。アナリストの投稿は一日中更新されます。10 アナリスト機関Howard MillerCanaccord GenuityMark BrewerCavendishMichael MitchellCavendish7 その他のアナリストを表示
お知らせ • Apr 28MEDLEAP Pharma Confirms Enrollment in Phase II Clinical Trial for Accrufer in JapanShield 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.
お知らせ • Apr 11Shield Therapeutics plc, Annual General Meeting, Jun 18, 2026Shield 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
お知らせ • Apr 02Shield Therapeutics plc Announces European Medicines Agency Approves Extension of Indication for FeRACCRU to Include AdolescentsShield 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.
お知らせ • Mar 05Shield Therapeutics Plc Announces Chinese NMPA Accepts MAA Submission For ACCRUFeRShield 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.
お知らせ • Feb 18Shield Therapeutics plc Announces U.S. Food and Drug Administration Approval of ACCRUFeRShield 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.
お知らせ • Feb 11Shield Therapeutics plc Announces FDA Grants Additional 3 Years Exclusivity for ACCRUFeRShield 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).
お知らせ • Apr 28MEDLEAP Pharma Confirms Enrollment in Phase II Clinical Trial for Accrufer in JapanShield 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.
お知らせ • Apr 11Shield Therapeutics plc, Annual General Meeting, Jun 18, 2026Shield 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
お知らせ • Apr 02Shield Therapeutics plc Announces European Medicines Agency Approves Extension of Indication for FeRACCRU to Include AdolescentsShield 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.
お知らせ • Mar 05Shield Therapeutics Plc Announces Chinese NMPA Accepts MAA Submission For ACCRUFeRShield 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.
お知らせ • Feb 18Shield Therapeutics plc Announces U.S. Food and Drug Administration Approval of ACCRUFeRShield 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.
お知らせ • Feb 11Shield Therapeutics plc Announces FDA Grants Additional 3 Years Exclusivity for ACCRUFeRShield 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).
お知らせ • Nov 11Shield Therapeutics plc Announces the Presentation of Accrufer Pediatric Pharmacokinetic (Pk) StudyShield 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.
お知らせ • Nov 09Shield Therapeutics plc Receives Marketing Authorisation by Korean Ministry of Food and Drug SafetyShield 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.
お知らせ • Sep 15Shield 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
お知らせ • Sep 04Shield Therapeutics plc Announces ACCRUFeR® Assigned Priority Review in US by FDAShield 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.
お知らせ • Aug 28Shield Therapeutics plc Announces Positive Efficacy and Safety Results in the Orion-Hf StudyShield 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.
お知らせ • Mar 12Shield Therapeutics plc Launches ACCRUFeR in Partnership with Kye Pharmaceuticals, IncShield 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.
お知らせ • Jan 27+ 1 more updateShield Therapeutics plc Announces Board ChangesShield Therapeutics plc announced that upon taking on the CEO role on a permanent basis Anders Lundstrom will step down from his position as Chair of the Remuneration Committee which position will be taken on by Dr. Christian Schweiger, one of the Company's non-executive Directors. Since Anders' appointment in July, his leadership has been instrumental in driving Shield's growth and operational efficiency. Under his guidance, the Company has experienced increases in revenues and net pricing for ACCRUFeR in the United States and fostered strengthened relationships with key partners and shareholders. These efforts have helped provide additional support to Shield's long-term strategic goals. Anders has also played a pivotal role in streamlining operations, positioning the Company for success as it works towards its goal of becoming cash flow positive by the end of 2025.
お知らせ • Dec 08Shield 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
お知らせ • Aug 27Shield Therapeutics plc Announces Health Canada Approves ACCRUFeR as Prescription Drug for the Treatment of Adults with Iron Deficiency AnemiaShield 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.
お知らせ • Aug 14Shield Therapeutics plc to Report First Half, 2024 Results on Sep 04, 2024Shield Therapeutics plc announced that they will report first half, 2024 results on Sep 04, 2024
お知らせ • Jul 24Shield Therapeutics plc Announces CEO ChangesShield 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).
お知らせ • Jul 03Rudolf Widmann Joins Board of Shield Therapeutics plc as Non-Executive DirectorShield 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.
お知らせ • May 15Shield Therapeutics plc, Annual General Meeting, Jun 20, 2024Shield 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
お知らせ • May 01Shield Therapeutics plc to Report Fiscal Year 2023 Final Results on May 10, 2024Shield Therapeutics plc announced that they will report fiscal year 2023 final results on May 10, 2024
お知らせ • Apr 16Shield Therapeutics plc to Report Fiscal Year 2023 Final Results on Apr 30, 2024Shield Therapeutics plc announced that they will report fiscal year 2023 final results on Apr 30, 2024
お知らせ • Jan 10Shield Therapeutics Appoints Santosh Shanbhag as New CFO, Effective January 16, 2024Shield 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.
お知らせ • Oct 12Shield Therapeutics plc Announces Hans-Peter Rudolf Is Standing Down from His Role as Chief Financial Officer on 20 October 2023Shield 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.
お知らせ • Oct 05Shield 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
お知らせ • Sep 29Shield 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
お知らせ • Sep 08Shield Therapeutics plc to Report First Half, 2023 Results on Sep 28, 2023Shield Therapeutics plc announced that they will report first half, 2023 results on Sep 28, 2023
お知らせ • May 20Shield Therapeutics plc, Annual General Meeting, Jun 28, 2023Shield 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
