Diamyd (rhGAD65/alum) / Diamyd Medical - LARVOL DELTA

Treatment with intralymphatic GAD in patients with LADA: follow-up of a clinical trial (EASD 2026) - "Inguinal node injections with GAD-alum (performed for the first time in LADA patients) were accompanied by effects on immunological and beta-cell variables; these effects we have followed up 2-3 years afterwards... 1) Beta cell decline in LADA is heterogeneous, 2) decline is equally well reflected in two stimulation tests and in fasting C- peptide 3) graded levels of GADA above the upper limit of quantification in most assays are prognostic of decline, 4) PMBC responses to GAD are fleeting and not prognostic of decline."

Clinical • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

Longitudinal C-peptide soon after diagnosis predicts glycaemic control in type 1 diabetes: blinded data from the DIAGNODE-3 trial (EASD 2026) - P3 | "Materials and This analysis used blinded data from the phase 3 DIAGNODE-3 trial evaluating retogatein (rhGAD65) in individuals recently diagnosed with type 1 diabetes carrying the HLA DR3-DQ2 haplotype... Higher residual C-peptide levels have a meaningful clinical impact on glycemic control, with the most pronounced benefits observable in TITR, followed by TIR and HbA1c. This pattern suggests that endogenous insulin production after diagnosis complements exogenous insulin replacement therapy, especially contributing to more stable glucose regulation in the normal range. Our findings underscore the clinical value of preserving C-peptide, supporting efforts to maintain endogenous insulin secretion through disease modifying therapies."

Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

Tracking GAD-specific T-cell expansions in Type 1 diabetes by intradermal GAD-Alum challenge. (PubMed, JCI Insight) - "These results demonstrate the intradermal autoantigen challenge and scRNAseq, enable direct identification and molecular profiling of autoreactive T cells in vivo. This minimally invasive approach provides a powerful platform for tracking antigen-specific T cells to monitor disease activity and evaluate immune interventions in T1D."

Journal • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus • CD4

DIAGNODE-3: A Phase III Study to Investigate if the Study Drug Diamyd Can Preserve Insulin Production and Improve Glycemic Control in Patients Newly Diagnosed With Type 1 Diabetes (clinicaltrials.gov) - P3 | N=321 | Terminated | Sponsor: Diamyd Medical AB | Trial completion date: Dec 2027 ➔ Jun 2026 | Active, not recruiting ➔ Terminated | Trial primary completion date: Dec 2027 ➔ Jun 2026; Stopped for futility.

Trial completion date • Trial primary completion date • Trial termination • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

Study to Evaluate the Safety and Feasibility of Diamyd® in Individuals at Risk for Type 1 Diabetes (clinicaltrials.gov) - P2 | N=5 | Active, not recruiting | Sponsor: Diamyd Medical AB | Recruiting ➔ Active, not recruiting | N=16 ➔ 5

Enrollment change • Enrollment closed • Diabetes • Immunology • Metabolic Disorders • Type 1 Diabetes Mellitus

Testing LADA diabetes status 3 years after treatment with intranodal GAD-alum. (clinicaltrialsregister.eu) - P1/2 | N=14 | Completed | Sponsor: Norwegian University Of Science And Technolology | Not yet recruiting ➔ Completed

Trial completion • Diabetes • Immunology • Metabolic Disorders

FINERENONE IN CHRONIC KIDNEY DISEASE AND TYPE 1 DIABETES (ISN-WCN 2026) - P3 | "Introduction Type 1 diabetes (T1D) is currently estimated to affect 9.5 million people globally, and approximately 30% of these people are expected to have chronic kidney disease (CKD). RL is a full-time employee of Bayer AG. JBM reports personal fees from Bayer, Lilly, MannKind, and Novo Nordisk; and research support from Biomea Fusion, Breakthrough T1D, Diamyd Medical, Lexicon, NIH, and Novo Nordisk.I did not use generative AI and AI-assisted technologies in the writing process."

Late-breaking abstract • Cardiovascular • Chronic Kidney Disease • Diabetes • Diabetic Nephropathy • Metabolic Disorders • Nephrology • Renal Disease • Type 1 Diabetes Mellitus • Type 2 Diabetes Mellitus

EFFICACY AND SAFETY OF FINERENONE AND EMPAGLIFLOZIN IN PATIENTS WITH INITIAL DECLINE IN ESTIMATED GLOMERULAR FILTRATION RATE: A CONFIDENCE TRIAL PRESPECIFIED ANALYSIS (ISN-WCN 2026) - "is the principal investigator on grants to Washington University from Biomea, Diamyd, Breakthrough T1D (formerly Juvenile Diabetes Research Foundation), Lexicon, the National Institutes of Health, and Novo Nordisk; has received royalties or licenses from Washington University; has received consulting fees from Bayer, ClearNote Health, Lilly, Mannkind, Novo Nordisk, and Thermo Fisher; payment or honoraria from Medscape, Thermo Fisher, Bayer, Med Learning Group, and Baylor; has participated on a data safety monitoring board for the Jaeb Center, Washington University, and the National Institutes of Health; has received support for attending meetings and/or travel from the Endocrine Society, Mannkind, Western Endocrine Society, Kansas Diabetes Symposium; and holds a leadership or fiduciary role with the Diabetes Technology Access Group. R.A. has received nonfinancial support from Akebia Therapeutics, Alnylam, Bayer Healthcare Pharmaceuticals, Boehringer Ingelheim, Intercept,..."

Clinical • Late-breaking abstract • Chronic Kidney Disease • Diabetes • Diabetic Nephropathy • Metabolic Disorders • Nephrology • Renal Disease • Type 1 Diabetes Mellitus • Type 2 Diabetes Mellitus • CLU • CST3 • KIM1 • LCN2 • SPP1

CONFIDENCE ASIA: EFFECT OF SIMULTANEOUS INITIATION OF FINERENONE AND EMPAGLIFLOZIN ON URINARY ALBUMIN-TO- CREATININE RATIO IN ASIAN PARTICIPANTS FROM THE CONFIDENCE TRIAL (ISN-WCN 2026) - "is the principal investigator on grants to Washington University from Biomea, Diamyd, Breakthrough T1D (formerly Juvenile Diabetes Research Foundation), Lexicon, the National Institutes of Health, and Novo Nordisk; has received royalties or licenses from Washington University; has received consulting fees from Bayer, ClearNote Health, Lilly, Mannkind, Novo Nordisk, and Thermo Fisher; payment or honoraria from Medscape, Thermo Fisher, Bayer, Med Learning Group, and Baylor; has participated on a data safety monitoring board for the Jaeb Center, Washington University, and the National Institutes of Health; has received support for attending meetings and/or travel from the Endocrine Society, Mannkind, Western Endocrine Society, Kansas Diabetes Symposium; and holds a leadership or fiduciary role with the Diabetes Technology Access Group. M.N. has received research grants from Astellas, Bayer, Boehringer Ingelheim, Chugai, Daiichi Sankyo, JT, Kyowa-Kirin, Takeda,..."

Chronic Kidney Disease • Diabetes • Diabetic Nephropathy • Metabolic Disorders • Nephrology • Renal Disease • Type 1 Diabetes Mellitus • Type 2 Diabetes Mellitus

CT-SY24-1: Symposium - Precision Medicine for New Onset Type 1 Diabetes: Interim Phase 3 Outcomes of Retogatein (rhGAD65) Antigen Immunotherapy in DIAGNODE-3 (ADA 2026) - No abstract available

P3 data • P3 data: top line • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

THE ANTIGEN-SPECIFIC IMMUNOTHERAPY RHGAD65 DELAYS PROGRESSION OF STAGE 3 T1D IN INDIVIDUALS WITH HLA DR3-DQ2 – SURVIVAL ANALYSIS OF COMBINED DATA FROM THREE RANDOMIZED TRIALS (ATTD 2026) - "Results suggest that rhGAD65 delays progression of stage 3 T1D by preserving functional beta cells function at a clinically relevant level. If confirmed in the ongoing Phase 3 trial DIAGNODE-3, these results support a durable disease-modifying effect of rhGAD65."

Clinical • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

Diamyd Medical | Diamyd Medical Accelerates the First Precision Medicine Phase 3 Program in Type 1 Diabetes (ATTD 2026) - No abstract available

P3 data • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

Study to Evaluate the Safety and Feasibility of Diamyd® in Individuals at Risk for Type 1 Diabetes (clinicaltrials.gov) - P2 | N=16 | Recruiting | Sponsor: Diamyd Medical AB | Trial completion date: Dec 2026 ➔ Mar 2028 | Trial primary completion date: Dec 2026 ➔ Mar 2028

Trial completion date • Trial primary completion date • Diabetes • Immunology • Metabolic Disorders • Type 1 Diabetes Mellitus

DIAGNODE-3: A Phase III Study to Investigate if the Study Drug Diamyd Can Preserve Insulin Production and Improve Glycemic Control in Patients Newly Diagnosed With Type 1 Diabetes (clinicaltrials.gov) - P3 | N=330 | Active, not recruiting | Sponsor: Diamyd Medical AB | Recruiting ➔ Active, not recruiting

Enrollment closed • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

Exploring the Frontiers of Diabetes Vaccination. (PubMed, Indian J Community Med) - "In this review, we offer a snapshot of the current efforts in diabetes vaccine development, describing the target molecules on the antigens, their mechanisms of action, and the research progress status. It highlights the imperativeness of importance of ongoing investigations for the invention of vaccines as well as the provision of new therapeutic options for diabetic persons."

Journal • Diabetes • Infectious Disease • Inflammation • Metabolic Disorders • Type 2 Diabetes Mellitus

The antigen-specific immunotherapy rhGAD65 delays progression of stage 3 type 1 diabetes in individual with HLA DR3-DQ2: survival analysis of combined data from three randomised controlled trials (EASD 2025) - "These meta-analysis results suggest that rhGAD65 delays progression of stage 3 T1D with an absolute benefit for preserving functional beta cell reserve at a physiologically meaningful level. If confirmed in the ongoing Phase 3 trial DIAGNODE-3, these results support a durable disease-modifying effect manifesting as a delay in C-peptide loss below critical levels."

Clinical • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

Factors associated with slower progression to stage 3 type 1 diabetes in children with multiple islet autoantibodies (EASD 2025) - P2 | "The studies aimed to evaluate the safety and efficacy of two doses of GAD-Alum on progression to stage 3 type 1 diabetes, both failing to demonstrate a significant treatment effect... Eight factors were associated with a slower progression: 1) male sex, 2) stage 1 type 1 diabetes, 3) normal BMI SDS, 4) low HbA1c, 5) high early C-peptide response, 6) normal neutrophil count at baseline, 7) a lower number of autoantibodies, 8) lack of IA-2A and ZnT8A. BMI SDS stands out as a potentially influenceable protective factor needing further investigation."

Clinical • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

Diamyd Medical highlights…upcoming Phase 3 readout (PRNewswire) - "Diamyd Medical expects several key milestones within the next 12 months including: Top-line results from its single pivotal Phase 3 trial DIAGNODE-3 to support an accelerated approval pathway in the U.S. GMP certification of its biologics manufacturing facility in Sweden."

P3 data: top line • Type 1 Diabetes Mellitus

Australia grants Diamyd Medical patent for novel antigen combination in autoimmune diabetes treatment (Diamyd Press Release) - "The Australian Patent Office has granted a patent protecting a novel immunotherapeutic composition developed by Diamyd Medical for use in the treatment and prevention of autoimmune diabetes. The patent, valid until 2035, covers a composition comprising the antigens glutamic acid decarboxylase (GAD) and proinsulin immobilized on separate carrier particles."

Patent • Diabetes • Immunology

Long-term gamma-aminobutyric acid (GABA) treatment fails to regain beta-cell function in longstanding type 1 diabetes in a randomized trial. (PubMed, Sci Rep) - "This phase I/II randomized controlled trial assessed the safety and efficacy of long-term treatment with Remygen® (Diamyd Medical), a controlled-release oral GABA formulation, as a potential beta-cell regenerative therapy in adults with long-standing T1D. Thirty-five male subjects with T1D (≥ 5 years) were randomized into three arms receiving the study drug(s) once daily for 6 months: GABA 200 mg (Arm 1), GABA 600 mg (Arm 2) and GABA 600 mg + alprazolam 0.5 mg for 3 months followed by GABA 600 mg alone for 3 months (Arm 3)...Hypoglycemic hormonal counter-regulation was unaltered. To conclude, we found no clinical evidence of a beta-cell regenerative effect of GABA, but side effects were commonly observed."

Clinical • Journal • Diabetes • Inflammation • Metabolic Disorders • Type 1 Diabetes Mellitus

IMPROVED GLYCEMIC CONTROL IN TYPE 1 DIABETES PATIENTS CARRYING HLA DR3-DQ2: FURTHER INSIGHTS FROM CONTINUOUS GLUCOSE MONITORING FROM THE PHASE 2B DIAGNODE-2 TESTING RHGAD65 (ATTD 2025) - "Results Better meal-related glucose control, including significantly lower pre-prandial, peak-prandial and post-prandial glucose values were seen in patients carrying HLA DR3-DQ2 treated with rhGAD65 compared to placebo. In this group, rhGAD65 treated patients had more time in range (3.9-10 mmol/L) less time spent in severe hyperglycemic range (>13.9 mmol/L) and shorter hyperglycemic episodes compared to placebo.Conclusions In addition to preserving beta cell function, treatment with rhGAD65 significantly improves glycemic control during meals and reduces the duration of hyperglycemic episodes in newly diagnosed T1D patients carrying HLA DR3-DQ2."

Clinical • P2b data • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

Diamyd Medical | Pathway to accelerated approval for precision medicine in type 1 diabetes (ATTD 2025) - "Sponsored by Diamyd Medical"

Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

Redosing with Intralymphatic GAD-Alum in the Treatment of Type 1 Diabetes: The DIAGNODE-B Pilot Trial. (PubMed, Int J Mol Sci) - "The mean % TIR increased while the mean daily insulin dose decreased at month 12 compared to the baseline. Redosing with GAD-alum seems to be safe and tolerable, and may prolong the disease modification elicited by the original GAD-alum treatment."

Clinical • Journal • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

Diamyd Medical confirms key advances toward Accelerated Approval for Diamyd following FDA Type C Meeting (PRNewswire) - "Diamyd Medical provides an update following the receipt of final meeting minutes from a positive Type C meeting with the U.S. Food and Drug Administration (FDA) held in December 2024. The meeting focused on refining study protocol and analysis strategies for Diamyd (rhGAD65/alum) in preparation for Accelerated Approval of the antigen-specific immunotherapy targeting Stage 3 Type 1 Diabetes...The FDA provided affirmative feedback on several pivotal aspects of Diamyd Medical's development program, including...Confirmation that the ongoing DIAGNODE-3 Phase 3 trial aligns with requirements for an Accelerated Approval, leveraging interim efficacy data based on stimulated C-peptide as the primary endpoint from approximately 170 evaluable participants who will complete their 15-month assessments by early 2026."

FDA event • Trial status • Type 1 Diabetes Mellitus

DIAGNODE-3: A Phase III Study to Investigate If the Study Drug Diamyd Can Preserve Insulin Production and Improve Glycemic Control in Patients Newly Diagnosed with Type 1 Diabetes (clinicaltrials.gov) - P3 | N=330 | Recruiting | Sponsor: Diamyd Medical AB | Trial completion date: Dec 2025 ➔ Dec 2027 | Trial primary completion date: Dec 2025 ➔ Dec 2027

Trial completion date • Trial primary completion date • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus