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  • Ulf Hannelius

    CEO


    Box 7349, SE-103 90 Stockholm
    +46 8 661 00 26
    https://www.diamyd.com

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    Diamyd Medical announces that Niklas Axelsson has decided to leave his position as CFO to take on a new role in another company

    A review to find a successor will now begin, and Niklas will remain with the company for some time to enable a handover to this person.  "Although Niklas has worked for Diamyd for a relatively short period, he has left a mark on the organization. I want to express gratitude on behalf of the company – especially regarding the role he played in our most recent fund raising – and wish him success in his continued career," says Anders Essen-Möller, CEO of Diamyd Medical. About Diamyd MedicalDiamyd Medical is a Swedish biotechnology company focused on precision medicine approaches for

    Diamyd Medical receives GMP certification and manufacturing authorization for biological investigational medicinal products for human use

    Diamyd Medical today announced a significant advancement in the company’s operations related to the manufacturing of biological medicines (biologics). The company has now received GMP (Good Manufacturing Practice) certification as well as manufacturing authorization from the Swedish Medical Products Agency for the production of biological investigational medicinal products for human use. The certification and authorization confirm that Diamyd Medical’s manufacturing facility complies with current regulatory requirements and international quality standards for pharmaceutical production.

    Diamyd Medical provides an update on strategic review and financial position

    Diamyd Medical today announces that the initial phase of the strategic review, initiated following the discontinuation of the Phase 3 DIAGNODE-3 trial, has been completed. Strategic review updateThe initial review phase has resulted in the identification of a short list of potential counterparties, and the Company will now proceed with a focused evaluation of these. As part of the review, Diamyd Medical is also evaluating strategic alternatives for its biomanufacturing facility in Umeå including potential stand-alone opportunities, or a divestment. With respect to retogatein (

    Diamyd Medical strengthens its position in the manufacturing of biological medicines – positive feedback from the Swedish Medical Products Agency

    Diamyd Medical today announces a significant advancement in the company’s operations related to the manufacturing of biological medicines (biologics). The company has successfully established manufacturing capacity in accordance with current quality requirements and regulatory guidelines, representing an important step in its continued development. The company has also received positive feedback from the Swedish Medical Products Agency regarding a previously conducted inspection. As a result, Diamyd Medical expects to obtain manufacturing authorization and a GMP (Good Manufacturing

    Diamyd Medical announces governance and leadership update

    Further to the Company’s press release regarding governance changes following the March 27 interim analysis of its DIAGNODE-3 study, Diamyd Medical today announces that Chairman Anders Essen-Möller has been appointed Chief Executive Officer. Vice Chairman Erik Nerpin has been appointed Chairman of the Board. As previously announced, Ulf Hannelius has stepped down from his role as CEO and will remain in a supervisory capacity during his notice period to support the transition. About Diamyd MedicalDiamyd Medical develops precision medicine therapies to prevent and treat type 1 diabetes.

    Diamyd Medical announces governance and leadership changes

    Following Diamyd Medical’s unexpectedly negative results from the March 27 interim analysis of its DIAGNODE-3 study, the Board of Directors has implemented governance changes to strengthen oversight and strategic direction. As part of these changes, CEO Ulf Hannelius has decided to step down from his role. Since the first announcement March 27 of the failed Phase 3 Diagnode-3 study, the Company has initiated a strategic review including 1) discussions with possible partners, 2) reducing its Stockholm activities, and 3) moving its BioManufacturing Plant in Umeå towards GMP certification

    Diamyd Medical discontinues DIAGNODE-3 following evaluation confirming futility; initiates strategic review

    Diamyd Medical today announced that it will discontinue the Phase 3 DIAGNODE-3 trial evaluating retogatein (rhGAD65) in Stage 3 type 1 diabetes. Following the previously reported interim analysis and subsequent evaluation of the interim results, including independent external statistical validation, the Company has concluded that the interim results meet the pre-specified futility criteria and do not support continuation.The interim analysis results, first announced on Friday March 27, were based on 174 evaluable participants followed from baseline to month 15. The results showed no

    Bulletin from Diamyd Medical’s Extraordinary General Meeting 2026

    An Extraordinary general meeting of Diamyd Medical Aktiebolag (the “Company”) was held on April 8, 2026. The Extraordinary General Meeting resolved to approve the board of directors’ resolution from March 23, 2026, to issue not more than 24,875,066 warrants, entailing an increase in the share capital of not more than SEK 2,522,860.285362 if all warrants are exercised. The issue constitutes the second tranche of the directed issuances announced by the Company on March 23, 2026. The right to subscribe for the new warrants shall, with deviation from the shareholder’s pre-emptive rights, be

    Diamyd Medical updates on the interim efficacy analysis of Phase 3 DIAGNODE-3 trial

    Diamyd Medical on Friday March 27[th] announced that the pre-specified interim efficacy analysis on 174 out of 321 participants of the ongoing Phase 3 DIAGNODE-3 trial yielded results that were unexpected and not aligned with prior retrospective or prospective data. This lack of alignment underscores the need for thorough evaluation of the interim analysis results. Based on the interim dataset, no treatment effect on C-peptide was observed, neither in the overall population nor in pre-specified subgroups, including the previously identified potential super responder group.“This outcome is

    Diamyd Medical reports negative interim results of Phase 3 DIAGNODE-3 trial

    Diamyd Medical today announced the completion of a pre-specified interim efficacy analysis on C-peptide in the ongoing pivotal Phase 3 DIAGNODE-3 trial evaluating retogatein (rhGAD65) in individuals with recent-onset Stage 3 type 1 diabetes carrying the HLA DR3-DQ2 haplotype. The interim analysis that included 174 out of 321 study participants did not demonstrate statistical significance on the primary endpoint at this timepoint. In addition to this, the pre-specified criteria required to support continuation of the trial were not met. No safety concerns were identified during the interim

    Quarterly Report 2 25/26

    September 2025 – February 2026, Diamyd Medical AB (publ), Fiscal year 2025/2026Precision Medicine for type 1 diabetes        Fully enrolled registrational Phase 3 programDiamyd Medical develops a proprietary platform of precision medicines for type 1 diabetes, a progressive autoimmune disease in which the immune system destroys the body’s own insulin production. The Company is advancing the fully enrolled registrational Phase 3 trial DIAGNODE-3 in the United States and Europe with an upcoming interim readout end of March 2026. Diamyd Medical’s B-share is traded on Nasdaq First North

    Diamyd Medical enters into equity financing agreements with new U.S. sector specialist investors for up to USD 125 million and announces full enrollment in Phase 3 trial

    NOT FOR PUBLICATION, DISTRIBUTION OR RELEASE, DIRECTLY OR INDIRECTLY, IN WHOLE OR IN PART, IN OR INTO THE UNITED STATES OF AMERICA, AUSTRALIA, CANADA, HONG KONG, ISRAEL, JAPAN, NEW ZEALAND, SOUTH AFRICA, SWITZERLAND OR ANY OTHER JURISDICTION WHERE SUCH PUBLICATION, DISTRIBUTION OR RELEASE WOULD BE UNLAWFUL OR REQUIRE REGISTRATION OR OTHER MEASURES. The Board of Directors of Diamyd Medical Aktiebolag (“Diamyd Medical” or the “Company”) has resolved on a directed issue of 17,226,500 new Class B shares at a subscription price of SEK 13.54 per share, through which the Company receives

    Diamyd Medical receives Notice of Grant in Japan for insulin-based antigen therapy patent in type 1 diabetes

    Diamyd Medical has received a Notice of Grant in Japan for a patent covering the use of insulin-based antigens to treat individuals with type 1 diabetes who carry the HLA DR4-DQ8 genetic marker. Once issued, the patent is expected to remain in force until 2038.Diamyd Medical holds granted precision medicine patents for treating and preventing type 1 diabetes in key global markets: · The newly granted Japanese patent for insulin-based antigen therapy targeting individuals with HLA DR4-DQ8 has corresponding patents granted in Europe, Eurasia, Hong Kong, and South Korea, with additional

    American Diabetes Association 86th Scientific Sessions to feature retogatein Phase 3 trial in dedicated symposium

    Diamyd Medical today announced that its pivotal Phase 3 DIAGNODE-3 trial evaluating retogatein (rhGAD65) in Stage 3 type 1 diabetes has been selected for a dedicated scientific symposium at the American Diabetes Association (ADA) 86[th] Scientific Sessions in New Orleans, June 5–8, 2026.“Selection of DIAGNODE-3 for a dedicated symposium by the ADA 2026 Scientific Sessions planning committee is an honor and underscores the scientific importance of this Phase 3 program and the increasing recognition of precision medicine approaches in type 1 diabetes”, said Ulf Hannelius, President and CEO of

    Diamyd Medical announces finalization of database for interim analysis in Phase 3 DIAGNODE-3 trial

    The clinical database has been finalized for the pre-specified interim efficacy analysis in Diamyd Medical’s ongoing pivotal Phase 3 trial (DIAGNODE-3) evaluating retogatein (rhGAD65) in individuals with Stage 3 type 1 diabetes. The outcome of interim analysis readout is expected by the end of March 2026.“This is a key milestone in DIAGNODE-3 and for our precision medicine strategy in type 1 diabetes,” says Ulf Hannelius, President and CEO of Diamyd Medical. “The interim analysis will provide the first Phase 3 assessment of retogatein’s potential to preserve insulin production in a

    Diamyd Medical receives Notice of Allowance for key retogatein US patent

    Diamyd Medical today announced that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for a patent covering the intralymphatic administration of retogatein (rhGAD65) with alum for the prevention and treatment of type 1 diabetes.The now allowed U.S. application is part of a patent family with corresponding rights already granted in Europe, Australia, Hong Kong, China, Canada, South Africa, Japan, Russia, and Israel. Upon grant, the U.S. patent will further strengthen Diamyd Medical’s international patent protection for a key component of its antigen-

    Quarterly Report 1 25/26

    September 2025 – November 2025 Diamyd Medical AB (publ), Fiscal year 2025/2026Precision Medicine for type 1 diabetesAiming for Accelerated Market Approval Diamyd Medical develops a proprietary platform of precision medicines for type 1 diabetes, a progressive autoimmune disease in which the immune system destroys the body’s own insulin production. Aligned with FDA, the Company plans for a March-2026 Early-Readout of its unique and registrational Phase 3 trial, with potential for an accelerated approval process in the United States. Diamyd Medical’s B-share is traded on Nasdaq First

    Diamyd Medical deepens long-term manufacturing collaboration for retogatein

    Diamyd Medical is taking the next step in a long-term manufacturing collaboration with APL and, in parallel, is initiating a strategic collaboration with NorthX Biologics to further develop and scale the manufacturing of retogatein (rhGAD65) ahead of commercialization.“This is a natural next step in work that has been built up over time,” says Ulf Hannelius, CEO of Diamyd Medical. By combining Diamyd Medical’s in-house drug substance manufacturing with APL’s long-standing fill and finish expertise and now adding the validation capabilities of NorthX Biologics, we are creating a sustainable

    Diamyd Medical announces completion of screening in pivotal Phase 3 DIAGNODE-3 trial

    Diamyd Medical today announced that the screening period in its pivotal Phase 3 DIAGNODE-3 trial evaluating retogatein (rhGAD65) in individuals with type 1 diabetes has been completed. Based on the number of patients screened, the Company expects approximately 310–320 participants to be randomized into the trial once enrollment is completed, which is expected by early March.“The completion of screening is a key milestone for DIAGNODE-3 and confirms strong operational momentum in our pivotal genetically defined Phase 3 program,” says Ulf Hannelius, CEO of Diamyd Medical. “With enrollment

    Diamyd Medical’s lead immunotherapy for type 1 diabetes receives global non-proprietary name retogatein

    Diamyd Medical today announced that its investigational antigen-specific immunotherapy for type 1 diabetes, commonly referred to as Diamyd, has been assigned the global non-proprietary name “retogatein” by the World Health Organization’s International Nonproprietary Names (INN) Programme and the United States Adopted Names Council (USAN).“The assignment of the non-proprietary name retogatein represents an important milestone in the development of our precision immunotherapy for type 1 diabetes,” says Ulf Hannelius, CEO of Diamyd Medical. “The INN and USAN provide a standardized global

    Diamyd Medical accelerates primary efficacy readout by 9 months in type 1 diabetes Phase 3 trial following FDA alignment and guidance

    Diamyd Medical has reached alignment with the U.S. Food and Drug Administration (FDA) to accelerate the primary efficacy readout in its ongoing pivotal, registrational Phase 3 DIAGNODE-3 trial in type 1 diabetes from 24 to 15 months, per FDA guidance, enabling the full primary efficacy readout of the trial to occur nine months earlier than previously planned and communicated. The previously announced interim efficacy readout, involving approximately 170 participants with 15-month data, remains on track for the end of March 2026 and may support an accelerated BLA pathway, consistent with FDA

    Diamyd Medical finalizing Phase 3 screening as GMP review progresses

    The number of randomized participants in DIAGNODE-3, Diamyd Medical’s registrational Phase 3 trial in type 1 diabetes, has now exceeded 290, and the screening will conclude in the coming weeks. The interim efficacy analysis of approximately 170 participants with 15-month data is scheduled for end of March 2026. The Company also confirms that its Umeå manufacturing facility is currently under review by the Swedish Medical Products Agency as part of the GMP-certification process.“Finalizing the screening phase is a major milestone and a significant achievement by all participating clinics in

    Bulletin from Annual General Meeting of Diamyd Medical AB

    The Annual General Meeting (the "AGM") of Diamyd Medical AB (publ) (the "Company") was held on December 4, 2025. Adoption of the annual accounts, discharge from liability and allocation of profitsThe AGM resolved to adopt the Company's income statement and balance sheet as well as the consolidated income statement and consolidated balance sheet and to discharge the Board of Directors and the CEO from liability for the financial year 2024/2025. The AGM resolved in accordance with the Board's proposal that no dividend be paid for the financial year 2024/2025. Board of Directors and

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