US/UK/Canada

Share

Contacts

  • Ulf Hannelius

    CEO


    Box 7349, SE-103 90 Stockholm
    +46 8 661 00 26
    https://www.diamyd.com

    • Links

    Pick a time period -
    Tags ( Active)

    American Diabetes Association 86th Scientific Sessions to feature retogatein Phase 3 trial in dedicated symposium

    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

    Diamyd Medical announces finalization of database for interim analysis in Phase 3 DIAGNODE-3 trial

    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 interim analysis readout is expected by the end of March 2026.“This is a key milestone in DIAGNODE-3 and for our precision medicine strategy in type 1 diabetes,” says Ulf Hannelius, President and CEO of Diamyd Medical. “The interim analysis will provide the first Phase 3 assessment of retogatein’s potential to preserve insulin production in a

    Diamyd Medical announces completion of screening in pivotal Phase 3 DIAGNODE-3 trial

    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 accelerates primary efficacy readout by 9 months in type 1 diabetes Phase 3 trial following FDA alignment and guidance

    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 guidance, enabling the full primary efficacy readout of the trial to occur nine months earlier than previously planned and communicated. The previously announced interim efficacy readout, involving approximately 170 participants with 15-month data, remains on track for the end of March 2026 and may support an accelerated BLA pathway, consistent with FDA

    Diamyd Medical finalizing Phase 3 screening as GMP review progresses

    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

    Diamyd Medical’s pivotal Phase 3 Type 1 Diabetes trial clears last safety review ahead of early readout in March 2026

    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 safety concerns and resulted in a recommendation to continue the trial as planned.DIAGNODE-3 is conducted under Fast Track and Orphan Drug Designations granted by the U.S. Food and Drug Administration (FDA), with an agreement in place that an early efficacy readout planned for March 2026 may serve as the basis for a Biologics License Application (

    Diamyd Medical’s pivotal Phase 3 Type 1 Diabetes trial clears second-to-last safety review ahead of early readout in March 2026

    The independent Data Safety Monitoring Board (DSMB) has completed its fifth scheduled safety review of Diamyd Medical’s registrational Phase 3 trial, DIAGNODE-3, evaluating the precision medicine immunotherapy Diamyd[®]. The review identified no safety concerns and resulted in a recommendation to continue the trial as planned.DIAGNODE-3 is conducted under Fast Track and Orphan Drug Designations granted by the U.S. Food and Drug Administration (FDA), with an agreement in place that an early efficacy readout planned for March 2026 may serve as the basis for a Biologics License Application (

    Diamyd Medical hits a recruitment milestone in DIAGNODE-3 Phase 3 trial

    180 patients have now been recruited in the precision medicine Phase 3 trial DIAGNODE-3, exceeding the recruitment target set for the planned early readout in March 2026. The readout is designed to support a potential accelerated Biologics License Application (BLA).“We are proud to have reached the 180-patient milestone, which is critical for the planned accelerated readout”, says Ulf Hannelius, CEO of Diamyd Medical. “This progress reflects the engagement and the strong support from our clinical sites and the Type 1 Diabetes community in advancing innovative, precision-based therapies.

    Diamyd Medical Announces Positive Interim Analysis Results for Phase 3 Trial in Type 1 Diabetes

    Diamyd Medical today announced a successful interim analysis (non-futility test) for its ongoing precision medicine Phase 3 DIAGNODE-3 trial. The interim analysis, reviewed by an independent Data Safety Monitoring Board (DSMB), resulted in a favorable recommendation to continue the trial without any modifications.“We are extremely pleased with the DSMB's recommendation to continue the DIAGNODE-3 trial as planned,” says Ulf Hannelius, CEO of Diamyd Medical. “This positive outcome reaffirms our confidence in the potential for Diamyd[®] to address an unmet medical need in Type 1 Diabetes. We

    Diamyd Medical updates on the registrational Phase 3 trial; upcoming interim analysis and enrollment

    Interim Analysis outcome scheduled for beginning of AugustThe Interim Analysis will be conducted in July by ICON plc, the appointed global CRO for the Phase 3 trial, and will be assessed by an independent Data Safety and Monitoring Board (DSMB). The DSMB is currently scheduled to convene on July 30[th] to evaluate the Interim Analysis outcome. The DSMB has approximately a week to inform Diamyd Medical of the conclusion of their meeting. As previously announced, an Interim Analysis of the ongoing precision medicine Phase 3 trial DIAGNODE-3 in Type 1 Diabetes will assess 6-month data

    Recruitment milestone reached in Diamyd® Phase 3 trial

    Diamyd Medical’s precision medicine Phase 3 trial for Type 1 Diabetes, DIAGNODE-3, has enrolled 100 patients. To date, no serious adverse events have been reported, and no patients have discontinued the trial.“This is an important milestone in our Phase 3 trial and the notable zero dropout rate confirms our insights from previous trials regarding the safety and convinience of the treatment,” says Ulf Hannelius, President & CEO of Diamyd Medical. “We are deeply grateful to our participants for their continued commitment to the trial and to the dedicated staff at our participating clinics for

    Diamyd Medical to present new genetic data at the ASIT summit in Boston, MA

    Diamyd Medical is invited as a speaker at the 7[th] Antigen Specific Immune Tolerance summit to be held in Boston, MA, on March 18-20, 2024. CEO Ulf Hannelius will  present up-to-date HLA haplotype frequency data in Type 1 Diabetes collected as part of the ongoing precision medicine Phase 3 trial DIAGNODE-3. The antigen-specific immunotherapy Diamyd[®] was recently, as previously announced,  awarded Fast Track designation by the FDA.“Genetic data that have been collected from the ongoing Phase 3 trial confirm the previously estimated prevalence of the genetic patient population we are

    Diamyd Medical receives U.S. FDA Fast Track designation for Diamyd®

    Diamyd Medical announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for Diamyd[®] (rhGAD65/alum) that is being investigated to improve glycemic control in recently diagnosed stage 3 Type 1 Diabetes patients with the genotype HLA DR3-DQ2. The FDA grants Fast Track designation to facilitate the development and expedite the review of medicines to treat serious conditions and fill an unmet medical need. Fast Track designation is intended to bring promising medicines to patients sooner.“We are very pleased with the FDA's decision to grant Fast Track

    In-depth analysis of Diamyd® Phase II trial further supports value of preserved insulin secretion

    An in-depth analysis of the continuous glucose monitoring data from the phase 2b trial DIAGNODE-2 with Diamyd[®] sheds new light on the importance of residual beta cell function in individuals recently diagnosed with Type 1 Diabetes. Most notably, the results show highly statistically significant and positive associations between residual beta cell function measured as stimulated C-peptide and reduction of the number and severity of hyperglycemic events, in other words episodes of high blood glucose levels, as well as improvments in glucose control during meal time. The results lend further

    Diamyd Medical partners with JDRF to advance the DIAGNODE-3 Phase 3 trial in Type 1 Diabetes

    Diamyd Medical and JDRF, the leading global type 1 diabetes research and advocacy organization, have entered into a four-year research and development collaboration including a non-dilutive $5 million award to Diamyd Medical to support its ongoing Phase 3 trial with the precision medicine antigen-specific immunotherapy Diamyd[®]. The grant will be funded under JDRF’s Industry Discovery & Development Partnerships program that focuses on commercialization of therapeutics and devices for the treatment, cure, and prevention of type 1 diabetes and its complications. “We could not have a

    First patient enrolled in Diamyd Medical's Phase III trial DIAGNODE-3

    The first patient has now received its first intralymphatic injection of Diamyd[®] in the precision medicine Phase III trial DIAGNODE-3. The trial will include approximately 330 patients aged 12 to 29 years newly diagnosed with Type 1 Diabetes who carry the genetically defined haplotype HLA DR3-DQ2.“The fact that the first patient is now enrolled in DIAGNODE-3 is a major milestone for the therapeutic diabetes vaccine Diamyd," says Ulf Hannelius, CEO of Diamyd Medical. “The Phase III trial is based on decisive scientific achievements in precision medicine, robust data, a unique and safe

    Diamyd Medical has opened the first clinic for the recruitment of patients for a Phase III trial in Type 1 Diabetes

    The first clinic has now been opened in the precision medicine Phase III trial DIAGNODE-3. The trial, designed to confirm the efficacy and safety of the antigen-specific immunotherapy Diamyd[®], will enroll approximately 330 patients aged 12 to 29 years recently diagnosed with type 1 diabetes and carrying the genetically defined HLA DR3-DQ2 haplotype.“DIAGNODE-3 is the result of years of hard work, important scientific advances and meticulous planning, and the fact that the first clinic has opened for patient recruitment is of course a significant milestone,” says Ulf Hannelius, CEO of

    Diamyd Medical proceeds with initiation of Type 1 Diabetes Phase III trial in Europe

    Diamyd Medical proceeds with the initiation of the Phase III trial DIAGNODE-3 in Europe with the Diamyd[®] diabetes vaccine. Results from in-depth analyses of the manufacturing process have shown no risk associated with a previously suspected contamination. The first patients are expected to be screened in March.“We are extremely happy and relieved to proceed with the initation of DIAGNODE-3 and I highly commend the team on their diligent efforts,” says Ulf Hannelius, CEO of Diamyd Medical. “We are now continuing at full speed and expect to screen the first patients in DIAGNODE-3 next month.

    Diamyd Medical receives first regulatory approval to start the Phase III trial DIAGNODE-3 with the diabetes vaccine Diamyd®

    Diamyd Medical announces today that The Swedish Medical Products Agency has given approval for the start of DIAGNODE-3, a placebo-controlled precision medicine Phase III trial with the diabetes vaccine Diamyd[®]. The trial is designed to confirm the efficacy and safety of Diamyd[®] in individuals recently diagnosed with type 1 diabetes, who carry the genetically defined haplotype HLA DR3-DQ2.“This is very gratifying and an important milestone for DIAGNODE-3,” says Ulf Hannelius, CEO of Diamyd Medical. ”We continue working at full pace with the applications and approvals in the other

    FDA pauses start of DIAGNODE-3 in the US pending clarification on study drug

    The start of the Phase III trial DIAGNODE-3 in the United States is being paused by the US Food and Drug Administration (FDA) to clarify certain outstanding questions regarding the study drug. Diamyd Medical will be notified of which questions that are outstanding within 30 days.A so-called "partial clinical hold" means that the FDA has not yet approved all parts of a study submission. The FDA has informed that it does not yet have sufficient information on questions concerning the study drug. The FDA will within 30 days provide more details on what information needs to be supplemented in

    Additional analyses show robust treatment effect of the therapeutic vaccine Diamyd®

    Diamyd Medical has, as part of interactions with regulatory agencies, conducted two new analyses on the large meta-analysis dataset of 627 individuals that participated in four previous placebo controlled clinical trials evaluating the efficacy and safety of the therapeutic diabetes vaccine Diamyd[®]. Both analyses support the clinical relevance and significance of the treatment benefits of Diamyd[®], which further support the design of the Phase III trial DIAGNODE-3 which is planned to start recruiting patients later this year.“These two analyses show the robustness of our data and provide

    Diamyd Medical secures precision medicine patent for prevention and treatment of autoimmune diabetes

    The European Patent Office has informed Diamyd Medical that the Company’s patent application regarding prevention and treatment of autoimmune diabetes in individuals carrying the HLA DR3-DQ2 gene will be granted. The patent is valid until 2035 and provides central protection in Europe for the treatment or prevention of genetically defined autoimumune diabetes using GAD, which is the active component in the therapeutic diabetes vaccine Diamyd[®]. The patent claims cover the patient population in which Diamyd[®] has shown efficacy and is targeted in the upcoming Phase III trial DIAGNODE-3.“

    There are no items matching the current filter
    There are no more items matching the current filter
    Back to top

    Subscribe