Diamyd Medical

What Diamyd Medical does

Diamyd Medical AB (publ) is a Swedish clinical-stage biotechnology company developing precision medicine therapies for Type 1 diabetes. Its lead asset, retogatein (rhGAD65/alum), is an investigational antigen-specific immunotherapy combining recombinant human GAD65 protein with alum adjuvant, administered intralymphatically to induce immune tolerance and preserve endogenous insulin production in genetically defined patients carrying the HLA DR3-DQ2 haplotype (approximately 40% of Type 1 diabetes patients). The company holds FDA Fast Track and Orphan Drug Designations, has built a global patent estate covering intralymphatic administration and precision medicine patient selection (DR3-DQ2 plus DR4-DQ8, covering up to 90% of T1D patients), and operates a GMP-certified 2,200 sqm biomanufacturing facility in Umeå built on Cytiva's FlexFactory platform.

The business model is pre-revenue from therapeutics. Commercial activity is limited to preclinical GAD65 protein sales (rhGAD65 and T-cell GAD65) to academic and industrial researchers, generating MSEK 0.4 in net sales for FY 2025/26. Any future therapeutic revenue was envisioned as BLA-approval-driven product sales and/or licensing royalties following a successful Phase 3 readout, but that pathway has been disrupted.

In March 2026, the pivotal Phase 3 DIAGNODE-3 trial was discontinued after an interim futility analysis showed no treatment effect on C-peptide in 174 evaluable participants, contradicting prior retrospective and Phase 2b data. Following the failure, founder Anders Essen-Möller was reappointed as CEO, most Stockholm employees were put on notice, and the company is now conducting a strategic review that includes exploring out-licensing/partnership for retogatein and evaluating divestiture of the Umeå biomanufacturing facility. The company holds cash and short-term investments of MSEK 346.4 as of May 31, 2026, and reported a net loss of MSEK -238.8 for FY 2025/26.

Name

Diamyd Medical

Legal name

Diamyd Medical AB (publ)

Website

https://diamyd.com

Company type

Public

Founded year

1996

Operating status

Operating

Headcount range

11–50 employees

Short description

Diamyd Medical is a Swedish clinical-stage biotech developing retogatein (rhGAD65/alum), an intralymphatic antigen-specific immunotherapy for genetically defined Type 1 diabetes. Following Phase 3 DIAGNODE-3 failure, the company is pursuing strategic alternatives including potential divestiture of its Umeå GMP facility.

Ownership category

akta.pro rank

Product category

Type 1 Diabetes Biopharmaceutical / Antigen-Specific Immunotherapy

NAICS

Pharmaceutical and Medicine Manufacturing (3254), Research and Development in Biotechnology (except Nanobiotechnology) (541714), Pharmaceutical Preparation Manufacturing (325412)

SIC

Pharmaceutical Preparations (2834), Biological Products, (No Disgnostic Substances) (2836)

akta.pro primary industry

Type 1 Diabetes Care (HLAKADAB)

akta.pro secondary industries

Cardiometabolic Pharmaceuticals (Cardiovascular/Diabetes/Obesity) (HLAIAAAE), Recombinant Protein Therapeutics (enzymes, hormones, growth factors) (HLAAAAAB)

Keywords

• Type 1 diabetes immunotherapy
• Precision medicine biotech
• Antigen-specific therapy
• Recombinant GAD65 protein
• Clinical-stage biopharmaceutical

Headquarters

HQ city

Stockholm

HQ country

Sweden

HQ region

Europe

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Supply Chain, Infrastructure

Revenue model

1. Preclinical GAD65 Protein Product Sales: Sale of research-grade GAD65 proteins (rhGAD65, T-cell GAD65) to academic and industry researchers for preclinical studies. Net sales were MSEK 0.4 for FY 2025/26, indicating minimal revenue at the clinical stage.
2. Future Therapeutic Product Revenue (post-approval): Following potential regulatory approval, retogatein would be commercialized as a disease-modifying therapy for Type 1 diabetes. Revenue streams would include product sales, potentially licensing royalties, and managed services arrangements.

Pricing tiers

Go-to-market motion1 record

Distribution channels1 record

Marketing channels5 records

Core offering

Diamyd Medical develops retogatein (rhGAD65/alum), an investigational antigen-specific immunotherapy administered intralymphatically to preserve endogenous insulin production in genetically defined Type 1 diabetes patients carrying the HLA DR3-DQ2 haplotype. The company also operates a GMP-certified biomanufacturing facility in Umeå, Sweden using Cytiva's FlexFactory platform, and sells research-grade GAD65 proteins (rhGAD65, T-cell GAD65) directly to academic and industrial preclinical researchers.

Product overview

Diamyd Medical's product portfolio centers on precision medicine therapies for type 1 diabetes, anchored by its lead candidate retogatein (rhGAD65/alum), an antigen-specific immunotherapy administered intralymphatically to preserve endogenous insulin production in genetically defined patients. The company supports this core product with a proprietary GMP-certified biomanufacturing facility in Umeå, Sweden, and sells GAD65 research proteins for preclinical use. The clinical development program includes the Phase 3 DIAGNODE-3 trial (discontinued) and the Phase 2 DiaPrecise prevention trial, all targeting the HLA DR3-DQ2 patient subgroup (~40% of type 1 diabetes patients).

Differentiator

Problem solved

Functional benefit

Products and services

• Retogatein (rhGAD65/alum) Investigational antigen-specific immunotherapy for the prevention and treatment of Type 1 diabetes, formulated as a suspension for injection containing recombinant human GAD65 protein (rhGAD65) mixed with alum adjuvant, administered intralymphatically. It targets individuals carrying the HLA DR3-DQ2 genetic haplotype (~40% of T1D patients) and is designed to preserve endogenous insulin production by inducing antigen-specific immune tolerance. Holds FDA Fast Track and Orphan Drug Designations.
• DiaPrecise Phase 2 Trial First precision prevention trial evaluating the safety and feasibility of intralymphatic administration of retogatein in individuals at risk for Type 1 diabetes (Stage 1 or Stage 2) carrying the HLA DR3-DQ2 haplotype. Enrolling 16 participants aged 8-18 years.
• GAD65 / rhGAD65 Research Protein Products GMP-manufactured research-grade GAD65 proteins sold directly to academia and industry for preclinical research use only (not for use in humans). Includes rhGAD65 (TB24001, 1mg vial at USD 2,450) and T-cell GAD65 (10-4508029-01, 1mg in RPMI/HSA buffer, price on request). Discounts offered for quantities above 1mg; 30-day payment terms.

Quantifiable outcome

• Preserving endogenous insulin production reduces risk of diabetes complications by 60-80%
• +2 more outcomes

Named customers2 records

Segments2 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

Four partnerships are on record, tiered core and minor.

• APL (Advanced Pharmaceutical Logistics)coreStrategic or Co-development PartnerDiamyd Medical deepened its long-term manufacturing collaboration with APL, a Swedish contract manufacturing organization (CMO), as part of preparations for potential BLA and future commercialization of retogatein. APL supports process validation, analytical methods, and CMC activities.
• NorthX BiologicscoreStrategic or Co-development PartnerSwedish contract manufacturing organization (CMO) engaged by Diamyd Medical to strengthen manufacturing readiness for retogatein, supporting process validation and CMC activities required for late-stage development and future commercialization.
• ASSET Partnership (Autoimmune Screening, Early Treatment)minorStrategic or Co-development PartnerASSET program coordinated by Diamyd Medical focusing on Type 1 diabetes screening. Financed by Swedish Innovation Agency VINNOVA. Organized the second annual Type 1 diabetes screening conference. The DiaPrecise Phase 2 prevention trial is conducted under the ASSET program.
• CytivacoreTechnology or IntegrationProvider of Cytiva's FlexFactory, a configurable single-use bioprocess platform used in Diamyd Medical's Umeå biomanufacturing facility for production of recombinant GAD65 protein.

Scale indicators11 records

Recent moves7 records

Expansion highlights5 records

Direct peers

• Provention Bio (a Sanofi company): Sanofi acquired Provention Bio in 2023, commercializing teplizumab — the first FDA-approved disease-modifying therapy for Type 1 diabetes (Stage 2). Most directly comparable to Diamyd in targeting antigen-specific immune mechanisms to delay or prevent T1D progression.
• Vertex Pharmaceuticals: Developing VX-880 (stem cell-derived islet cell therapy) and the broader VX-264 program for Type 1 diabetes. Competes with Diamyd in the same T1D disease-modifying therapeutic space, though via a cell-replacement rather than antigen-specific immunotherapy approach.
• ViaCyte (a Vertex company): Stem cell-derived islet cell replacement therapies for Type 1 diabetes; acquired by Vertex in 2022. Directly competes for the same T1D patient population targeting preservation/replacement of beta-cell function, with overlap in the clinical-stage biotech space.
• Tolerion: Clinical-stage company developing antigen-specific immunotherapies for Type 1 diabetes, including a GAD65-based approach similar to Diamyd's retogatein. Direct mechanistic and indication peer in the precision immunology T1D space.

Emerging players

• ImCyse: Belgian clinical-stage biotech developing Imotope™ immunotherapeutic peptides designed to halt autoimmune disease, with a T1D program. Comparable to Diamyd in antigen-specific immunotherapy approach and clinical-stage development profile.
• Oramed Pharmaceuticals: Developing oral insulin (ORMD-0801) and an oral GLP-1 for diabetes, with T1D relevance. Smaller clinical-stage peer with comparable company size and disease-modifying diabetes ambition.
• Caladrius Biosciences: Clinical-stage biotech developing CLBS03, an antigen-specific regulatory T-cell therapy for recent-onset Type 1 diabetes. Most directly comparable mechanistic peer — both companies pursued antigen-specific immunomodulation in newly diagnosed T1D.

Broad incumbents

• Sanofi: Global pharmaceutical leader with a major diabetes franchise (insulins, GLP-1s) and the recently commercialized teplizumab (via Provention Bio acquisition) for T1D. Broad incumbent that competes with Diamyd's eventual retogatein market opportunity.
• Novo Nordisk: Global diabetes leader with the broadest insulin portfolio plus emerging disease-modifying T1D initiatives. Large incumbent whose dominance defines the commercial landscape any T1D therapy company must enter.
• Eli Lilly: Major diabetes franchise (Humalog, Trulicity, Mounjaro/Zepbound) investing in earlier-stage T1D pipeline programs. Broad incumbent peer with the resources to acquire or compete with any disease-modifying T1D asset.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat3 records

Key risks6 records

Key highlights6 records

Customer concentration

• Xx.com/diamyd
• LinkedInlinkedin.com/company/diamyd-medical

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles11 records

Subsidiaries2 records

Funding overview

Funding rounds8 records

Investors13 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments1 record

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Diamyd Medical