DIAMYD Aktie

 

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 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...

September 2025 – February 2026, Diamyd Medical AB (publ), Fiscal year 2025/2026 Precision Medicine for type 1 diabetes        Fully enrolled registrational Phase 3 program 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. 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...

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The shareholders of Diamyd Medical Aktiebolag, Reg. No. 556242-3797, with its registered office in Stockholm, (the “Company” or “Diamyd Medical”), are hereby convened to the extraordinary general meeting on Wednesday 8 April 2026 at 13.00 (CEST) at the premises of Advokatfirman Vinge on Smålandsgatan 20, SE-111 46 Stockholm, Sweden. Registration to the extraordinary general meeting starts at 12.30 (CEST). Right to participate in the extraordinary general meeting and notice of participation A shareholder who wishes to participate in the extraordinary general meeting at the venue in person or...

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...

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...

STOCKHOLM, Feb. 24, 2026 /PRNewswire/ -- 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......

STOCKHOLM, Feb. 9, 2026 /PRNewswire/ -- 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......

September 2025 – November 2025 Diamyd Medical AB (publ), Fiscal year 2025/2026 Precision Medicine for type 1 diabetes Aiming 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 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 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 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...

STOCKHOLM, Dec. 29, 2025 /PRNewswire/ -- 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......

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...

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 profits The 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...

Diamyd Medical's Annual Report for the financial year 2024/2025 is now available in English. The Annual Report is attached as a PDF and is available at www.diamyd.com....

STOCKHOLM, Nov. 14, 2025 /PRNewswire/ -- The independent Data Safety Monitoring Board (DSMB) has completed its sixth scheduled safety review of Diamyd Medical's registrational Phase 3 trial, DIAGNODE-3, evaluating the precision medicine immunotherapy Diamyd®. The review identified no......

Diamyd Medical today publishes its Annual Report for 2024/25. The Company is in an expansive phase where positive feedback has been received from the US Food and Drug Administration (FDA) regarding the possibility of earlier market approval. The Annual Report is published in Swedish. The English version is expected to be published around December 5, 2025. - The development in type 1 diabetes has never had greater momentum, supported by a regulatory environment increasingly favoring disease-modifying therapies. With the FDA's fast track and orphan drug designations for our investigational...

On the World Diabetes Day, Diamyd Medical will host a live moderated discussion featuring leading experts in Type 1 Diabetes research and advocacy. The session will explore how advances in immune tolerance and precision medicine are driving the transition from symptom management to true disease modification in type 1 diabetes. The panel includes: · Professor Johnny Ludvigsson, Linköping University · Professor Åke Lernmark, Lund University · Joshua Vieth, Senior Director, Breakthrough T1D, US · Ulf Hannelius, CEO, Diamyd Medical, Stockholm “World Diabetes Day is an...