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<title>Shield Therapeutics Plc — News on 6ix</title>
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<description>Latest news and press releases for Shield Therapeutics Plc on 6ix.</description>
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<title>Shield Therapeutics Plc</title>
<link>https://6ix.com/company/shield-therapeutics-plc</link>
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<title>Enrollment in Phase II Clinical Trial for ACCRUFeR</title>
<link>https://6ix.com/company/shield-therapeutics-plc/news/enrollment-in-phase-ii-clinical-trial-for-accrufer</link>
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<pubDate>Mon, 27 Apr 2026 06:00:00 GMT</pubDate>
<description>Shield Therapeutics plc announced that its partner, MEDLEAP Pharma, has enrolled the first patient in a Phase II clinical trial for ACCRUFeR® (ferric maltol) in Japan for the treatment of Pulmonary Arterial Hypertension (PAH). This exploratory study is designed to support a future Phase III trial, following the Japanese Pharmaceuticals and Medical Devices Agency's confirmation of the development plan based on prior European, UK, and US trial results. The PAH market in Japan is estimated at over </description>
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<title>Audited results for year ended 31 December 2025</title>
<link>https://6ix.com/company/shield-therapeutics-plc/news/audited-results-for-year-ended-31-december-2025-2</link>
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<pubDate>Thu, 09 Apr 2026 11:30:00 GMT</pubDate>
<description>Shield Therapeutics plc reported audited results for the year ended 31 December 2025, with group net revenues and other income reaching $49.7 million, driven by a 56% increase in ACCRUFeR® net revenues to $45.8 million, making it the number one branded prescription oral iron in the US. The company achieved positive cash flow in Q4 2025 and anticipates an operating profit in 2026, with losses for the year reduced to $17.7 million from $27.2 million in 2024. Significant progress was made in expand</description>
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<title>Publication of Report, Reinforcing FDA Approval</title>
<link>https://6ix.com/company/shield-therapeutics-plc/news/publication-of-report-reinforcing-fda-approval</link>
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<pubDate>Wed, 01 Apr 2026 08:22:00 GMT</pubDate>
<description>Shield Therapeutics plc announced the publication of a peer-reviewed AdisInsight Report in Pediatric Drugs detailing the US Food and Drug Administration's approval to extend the indication for ACCRUFeR®/FeRACCRU® (ferric maltol) to include pediatric patients aged 10 years and over for iron deficiency treatment. This approval was supported by positive Phase 3 trial results demonstrating the efficacy, safety, and tolerability of a new oral liquid pediatric formulation in children from 1 month of a</description>
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<title>Total Voting Rights</title>
<link>https://6ix.com/company/shield-therapeutics-plc/news/total-voting-rights-727</link>
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<pubDate>Tue, 31 Mar 2026 06:03:00 GMT</pubDate>
<description>Shield Therapeutics plc has announced its total voting rights, confirming that its issued share capital consists of 1,068,418,471 ordinary shares of 1.5p each, with no shares held in treasury. This figure serves as the denominator for shareholders to determine notification requirements under the FCA's Disclosure Guidance and Transparency Rules.
Disclaimer*</description>
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<title>Chinese NMPA Accepts MAA Submission for ACCRUFeR®</title>
<link>https://6ix.com/company/shield-therapeutics-plc/news/chinese-nmpa-accepts-maa-submission-for-accruferr</link>
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<pubDate>Tue, 03 Mar 2026 07:00:00 GMT</pubDate>
<description>Shield Therapeutics plc announced that its licensing partner, Beijing Aosaikang Pharmaceutical Co. Ltd, has had its Marketing Authorisation Application for ACCRUFeR® accepted by the Chinese National Medical Products Administration for the treatment of iron deficiency in adults. This submission is supported by data from the US FDA approval and a Phase 3 study in Chinese adults demonstrating clinically relevant efficacy and good tolerance, comparable to prior trials in other ethnicities. This deve</description>
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<title>FDA Grants additional Exclusivity for ACCRUFeR</title>
<link>https://6ix.com/company/shield-therapeutics-plc/news/fda-grants-additional-exclusivity-for-accrufer</link>
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<pubDate>Mon, 09 Feb 2026 07:00:00 GMT</pubDate>
<description>Shield Therapeutics plc has secured an additional three years of Data Exclusivity for ACCRUFeR® from the US FDA, extending protection until December 19, 2028, following the successful completion of a Phase 3 pediatric clinical trial. This exclusivity is in addition to existing patent coverage for ACCRUFeR®/FeRACCRU® valid until the mid-2030s. The trial demonstrated the efficacy, safety, and tolerability of the new oral liquid pediatric formulation in children aged 1 month and older with iron def</description>
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<title>Approval for ACCRUFeR in China expected in Q1 2026</title>
<link>https://6ix.com/company/shield-therapeutics-plc/news/approval-for-accrufer-in-china-expected-in-q1-2026</link>
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<pubDate>Fri, 30 Jan 2026 07:00:00 GMT</pubDate>
<description>Shield Therapeutics plc announced that its partner in China, ASK, expects to file for marketing authorisation for ACCRUFeR® in Q1 2026, including pediatric data. The China License Agreement has been updated to include a $7.9 million development milestone payment to Shield by January 31, 2026, which Shield will use to settle and terminate its AOP Milestone Monetisation Agreement. Revised terms also include up to $3 million in milestones linked to final pricing and up to 10% royalties on net sales</description>
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<title>Q4 2025 Trading Update</title>
<link>https://6ix.com/company/shield-therapeutics-plc/news/q4-2025-trading-update-4</link>
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<pubDate>Wed, 21 Jan 2026 07:00:00 GMT</pubDate>
<description>Shield Therapeutics plc reported positive operating cash flow in Q4 2025 and full-year 2025 total revenues of approximately $50 million, a significant increase from $32 million in the prior year. The company's key product, ACCRUFeR®, saw its revenues grow by 56% to approximately $46 million in 2025, driven by a 21% rise in average net selling price to $223 and a 33% increase in total prescriptions to around 199,000. ACCRUFeR® net revenues in Q4 2025 reached $13.5 million, with prescriptions at a</description>
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<title>Block listing 6 Monthly Return</title>
<link>https://6ix.com/company/shield-therapeutics-plc/news/block-listing-6-monthly-return-4</link>
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<pubDate>Fri, 02 Jan 2026 11:06:00 GMT</pubDate>
<description>Shield Therapeutics plc has provided a six-monthly return for its share schemes, reporting a balance of 39,794 unallotted securities under the Retention Share Plan and 341,020 under the 2016 Company Share Option Plan, with no changes during the period from July 1, 2025, to December 31, 2025. The 2016 Long Term Incentive Plan also shows no activity, maintaining a balance of 24,273 unallotted securities. However, the Retention and Performance Share Plan saw an increase of 15,000,000 securities, wi</description>
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<title>FDA approves extension for ACCRUFeR®</title>
<link>https://6ix.com/company/shield-therapeutics-plc/news/fda-approves-extension-for-accruferr</link>
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<pubDate>Mon, 22 Dec 2025 07:00:00 GMT</pubDate>
<description>Shield Therapeutics plc announced that the US FDA has approved an expanded indication for ACCRUFeR® to include adolescents aged 10 years and older with iron deficiency, following positive results from a Phase 3 pediatric trial. The company plans to seek further approval for a new pediatric formulation, a ferric maltol suspension, for children aged 1 month and above, which could also serve as an alternative for adults unable to swallow capsules. This expansion significantly broadens the market fo</description>
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<title>Block Listing Application</title>
<link>https://6ix.com/company/shield-therapeutics-plc/news/block-listing-application-139</link>
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<pubDate>Thu, 18 Dec 2025 07:13:00 GMT</pubDate>
<description>Shield Therapeutics plc has applied to the London Stock Exchange for a block listing of 15,000,000 ordinary shares of 1.5 pence each, expected to be admitted to trading on December 23, 2025. These shares are intended for allocation to the Shield Therapeutics Retention and Performance Share Plan.
Disclaimer*</description>
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<title>Shield Wins Gold at Titan Branding Awards</title>
<link>https://6ix.com/company/shield-therapeutics-plc/news/shield-wins-gold-at-titan-branding-awards</link>
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<pubDate>Thu, 11 Dec 2025 07:00:00 GMT</pubDate>
<description>Shield Therapeutics plc has received a Gold award at the 2025 Titan Brand Awards for its rebranding of ACCRUFeR®, recognizing it as the Best Rebranding Effort and Best Healthcare Rebranding. This award highlights ACCRUFeR®'s successful transformation into a differentiated, patient-focused brand, contributing to its position as the number one branded prescription oral iron in the US iron deficiency/iron deficiency anemia market. The company views this as the initial step in its digital marketing </description>
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<title>Amends Senior Secured Debt Financing</title>
<link>https://6ix.com/company/shield-therapeutics-plc/news/amends-senior-secured-debt-financing</link>
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<pubDate>Wed, 03 Dec 2025 07:04:00 GMT</pubDate>
<description>Shield Therapeutics plc has amended its senior secured debt financing with SWK Holdings Corporation and the addition of Runway Growth Finance Corp, increasing the available funds to $50 million, including $15 million for future M&A. The loan facility maintains its original maturity date of September 28, 2028, but extends the interest-only period to 15 quarters and reduces the interest rate to 3 Month CME Term SOFR + 8.75% with a lower SOFR floor of 3.5%, effective January 15, 2026. Shield will p</description>
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<title>Initiation of a Phase II Clinical Trial in Japan</title>
<link>https://6ix.com/company/shield-therapeutics-plc/news/initiation-of-a-phase-ii-clinical-trial-in-japan</link>
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<pubDate>Fri, 14 Nov 2025 07:03:00 GMT</pubDate>
<description>Shield Therapeutics plc announced that its partner, MEDLEAP Pharma, has initiated a Phase II clinical trial in Japan for ACCRUFER® (ferric maltol) to treat Pulmonary Arterial Hypertension (PAH), a condition with an estimated market of over $230 million in Japan for 2024. This exploratory study, involving approximately 26 subjects and focusing on the 12-week change in 6-minute walk distance, follows confirmation of the development plan by the Pharmaceuticals and Medical Devices Agency (PMDA). Sub</description>
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<title>ACCRUFeR Pediatric PK Results to be Presented</title>
<link>https://6ix.com/company/shield-therapeutics-plc/news/accrufer-pediatric-pk-results-to-be-presented</link>
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<pubDate>Tue, 11 Nov 2025 07:00:00 GMT</pubDate>
<description>Shield Therapeutics plc announced that pharmacokinetic results from a Phase 3 pediatric trial of ACCRUFeR® (ferric maltol) will be presented at the American Society of Hematology Conference, confirming its suitability for iron replacement in children as young as one month. The study demonstrated that iron was well-absorbed at age-appropriate doses, and maltol was rapidly metabolized and excreted without accumulation across all age groups, including infants. These findings are crucial for support</description>
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<title>ACCRUFeR receives Authorisation by Korean Ministry</title>
<link>https://6ix.com/company/shield-therapeutics-plc/news/accrufer-receives-authorisation-by-korean-ministry</link>
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<pubDate>Fri, 07 Nov 2025 07:03:00 GMT</pubDate>
<description>Shield Therapeutics plc (LSE: STX) announced on 07 November 2025 that its product, ACCRUFeR® (Ferric Maltol), received Marketing Authorisation from the Korean Ministry of Food and Drug Safety for treating iron deficiency in adults in South Korea. This approval, following a successful pharmacokinetic study and a 2024 New Drug Application by Korea Pharma, expands ACCRUFeR®'s global reach. Shield is now eligible to receive payments upon the first sale, performance-based sales milestones, and royalt</description>
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<title>Q3 2025 Trading Update</title>
<link>https://6ix.com/company/shield-therapeutics-plc/news/q3-2025-trading-update-18</link>
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<pubDate>Thu, 23 Oct 2025 06:00:00 GMT</pubDate>
<description>Shield Therapeutics PLC reported its Q3 2025 trading update, highlighting its strongest quarterly performance to date. ACCRUFeR® prescriptions grew by approximately 15% compared to Q2 2025, reaching roughly 54,000. This prescription volume drove net revenues to $13.1 million, with an average net selling price of $237. In comparison, Q3 2024 saw $7.2 million in net revenues from approximately 44,000 prescriptions at an average net selling price of $167. The company's cash and cash equivalents sto</description>
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<title>Grant of Share Options to Chief Executive Officer</title>
<link>https://6ix.com/company/shield-therapeutics-plc/news/grant-of-share-options-to-chief-executive-officer</link>
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<pubDate>Tue, 14 Oct 2025 14:01:00 GMT</pubDate>
<description>Shield Therapeutics PLC announced on October 13, 2025, the grant of share options to its Group CEO, Anders Lundstrom, under the company's Retention and Performance Share Plan (RPSP) as part of his 2025 annual equity grant. Lundstrom, a person discharging managerial responsibility, received options over 1,547,262 ordinary shares. These options vest in three equal tranches over three years from the grant date, contingent on his continued employment. The option awards represent approximately 0.1% o</description>
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<title>Positive efficacy and tolerance in pediatric trial</title>
<link>https://6ix.com/company/shield-therapeutics-plc/news/positive-efficacy-and-tolerance-in-pediatric-trial</link>
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<pubDate>Wed, 01 Oct 2025 06:02:00 GMT</pubDate>
<description>Shield Therapeutics announced the presentation of positive results from its Phase 3 pediatric trial (FORTIS) for ACCRUFeR® at the American Association of Pediatrics (AAP) National Conference. The trial demonstrated clinically and statistically significant hemoglobin improvements versus baseline across all groups, including ferric maltol and ferrous sulfate arms, with a P value of less than 0.0001. Notably, no patients discontinued ferric maltol treatment due to adverse events, while one patient </description>
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<title>£1.5 million placing supporting growth of ACCRUFeR</title>
<link>https://6ix.com/company/shield-therapeutics-plc/news/pound15-million-placing-supporting-growth-of-accrufer</link>
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<pubDate>Mon, 15 Sep 2025 06:00:00 GMT</pubDate>
<description>Shield Therapeutics PLC announced the completion of a placing to raise gross proceeds of £1.5 million through the issue of 20,000,000 new ordinary shares at a price of 7.5 pence per share. The issue price represents a premium of approximately 5% to the 30-day VWAP of 7.13 pence per existing ordinary share up to September 12, 2025. The placing shares represent approximately 1.9% of the existing issued ordinary share capital. Admission to trading on AIM is expected on September 19, 2025, following</description>
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