Diamyd Medical AB (publ)
DMYD-B.ST
Stockholm Stock Exchange1.14
SEK
+0.02
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Diamyd Medical AB (publ)
DMYD-B.ST
(Stockholm Stock Exchange)
Recent
price
1.14
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ratio
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div
yld
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ROIC.AI
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- Diamyd Medical AB (publ) (Nasdaq First North Growth Market: DMYD B) develops precision medicine therapies for the prevention and treatment of autoimmune diabetes, including type 1 diabetes and latent autoimmune diabetes in adults (LADA); its lead product candidate, Diamyd, comprises recombinant human GAD65 formulated with aluminum hydroxide as an antigen-specific immunotherapy administered intralymphatically to preserve endogenous insulin production in patients carrying the HLA DR3-DQ2 genotype; Remygen consists of GABA-based investigational regenerative and immunomodulatory therapy aimed at restoring beta-cell function, improving hormonal responses to hypoglycemia, and treating type 1 diabetes, type 2 diabetes, and LADA. The company, founded in 1984 and headquartered at Kungsgatan 29 in Stockholm, Sweden, conducts late-stage clinical development through global networks of clinics across eight European countries and the United States; operations emphasize manufacturing recombinant GAD65 at a biomanufacturing facility under development in Umeå, Sweden; Diamyd Medical holds major shareholdings in stem cell therapy developer NextCell Pharma AB and artificial intelligence firm MainlyAI AB. Recent advancements include positive Data Safety Monitoring Board (DSMB) reviews and interim non-futility analysis for the ongoing confirmatory phase 3 DIAGNODE-3 trial evaluating Diamyd in recent-onset stage 3 type 1 diabetes patients, supporting an accelerated approval pathway with U.S. FDA Fast Track and Orphan Drug Designations and an early efficacy readout planned for March 2026 based on stimulated C-peptide levels in approximately 170 participants; topline results from the investigator-initiated ReGenerate-1 phase 1/2 trial confirmed Remygen met its primary endpoint of safety in long-term type 1 diabetes patients, with four participants dosed in the main study phase; financing efforts raised MSEK 315 through warrant redemptions, an oversubscribed rights issue providing MSEK 226, and a private placement of MSEK 42, complemented by a four-year research collaboration with Breakthrough T1D (formerly Juvenile Diabetes Research Foundation) funding up to MUSD 6.75 in milestone-based support for DIAGNODE-3; Swedish Medical Products Agency and Ethical Review Authority approvals enabled initiation of the phase 2 DiaPrecise prevention trial assessing Diamyd safety in children with stage 1 or 2 type 1 diabetes; positive Type C meeting outcomes with the U.S. FDA in December 2024 aligned Diamyds development milestones, statistical plans, and C-peptide as a surrogate endpoint for expedited biologics license application review.