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Diamyd Medical (DMYD) investor relations material
Diamyd Medical Q1 2026 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Executive summary
Entered final stage of pivotal Phase 3 DIAGNODE-3 trial for retogatein in type 1 diabetes, with patient screening completed and 310-320 participants expected for interim and full efficacy analyses.
Interim readout for approximately 170 participants on track for March 2026, potentially supporting accelerated approval in the US.
FDA alignment allowed shortening of primary efficacy follow-up from 24 to 15 months, accelerating full readout by nearly a year.
Retogatein received global non-proprietary name and maintains Orphan Drug and Fast Track designations.
Biomanufacturing facility in Umeå progressing toward GMP certification, with expanded manufacturing partnerships.
Financial highlights
Net sales for the quarter: MSEK 0.2 (previous year: 0.0).
Net result: MSEK -48.8 (previous year: -36.2).
Cash flow from operating activities: MSEK -43.7 (previous year: -41.8).
Cash and short-term investments at period end: MSEK 233.2 (previous year: 152.9).
Research and development costs: MSEK -30.5 (previous year: -26.1).
Outlook and guidance
Interim analysis in March 2026 will provide early insights into retogatein's efficacy and may support accelerated US approval.
Focus remains on executing clinical and regulatory strategy, manufacturing, and pre-commercial preparations.
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