contentSlug

type

ContentSlug_ContentQuery

slug

ContentPageContentQuery

content

trendingContent

query ContentSlug_ContentQuery(
  $contentSlug: String!
  $type: [ContentType!]
) {
  ...ContentPageContentQuery_13QmVO
}

fragment CompanyDetails_Content on Content {
  __isContent: __typename
  companies {
    name
    description
    pageUrl
    id
  }
}

fragment ContentBasicInfo on Content {
  __isContent: __typename
  id
  type
  title
  lang
  companies {
    viewerIsFollowing
    id
    name
    pageUrl
  }
  tags {
    viewerIsFollowing
    id
    name
    pageUrl
  }
  ...PublishingDetails
  ...Reactions
}

fragment ContentMetadata on Content {
  __isContent: __typename
  type
  title
  lang
  pageUrl
  alternatePageUrls: translations {
    __typename
    pageUrl
    lang
  }
  imgUrl
  description
  ... on Video {
    liveTime
    videoUrl
  }
  ... on Webcast {
    liveTime
    videoUrl
  }
}

fragment ContentPageContentQuery_13QmVO on Query {
  content(slug: $contentSlug, type: $type) {
    __typename
    id
    type
    title
    isPremium
    lang
    htmlBody
    summary
    companies {
      forum {
        latestPosts {
          ...ForumPosts
        }
      }
      name
      id
      viewerIsFollowing
      pageUrl
      defaultInstrument {
        isin
        id
        marketOpen
        marketClose
        marketplace {
          region
        }
        returns {
          total
        }
      }
    }
    tags {
      viewerIsFollowing
      id
      name
      pageUrl
    }
    createdAt
    ... on Video {
      liveTime
    }
    ... on Webcast {
      liveTime
    }
    slug
    ... on CompanyReport {
      reportUrl
    }
    ... on ThirdPartyCompanyReport {
      reportUrl
    }
    ... on StockExchangeRelease {
      reportUrl
    }
    ...ContentBasicInfo
    ...ContentMetadata
    ...PriceAndRecommendation_Content
    ...CompanyDetails_Content
    ...ReportLink_Content
    ...KeyFigures_Content
  }
  ...TrendingContent_1jQ2Cn
}

fragment ForumPosts on ForumPost {
  text
  likesCount
  url
  author
  postedAt
  authorImgUrl
}

fragment KeyFigures_Content on Content {
  __isContent: __typename
  companies {
    defaultInstrument {
      estimateData {
        modelType
        reportingCurrency
      }
      snapshot {
        transaction {
          date
          actualized {
            year
            quarter
            revenue
            revenueGrowth
            ebitAdjusted
            ebitReported
            ebitda
            enterpriseValue
            epsAdjusted
            dividend
            dividendYield
            sharePrice
            nav
            navPerShare
            opexOfNav
            quarterlySharePrice
          }
          estimates {
            year
            quarter
            revenue
            revenueGrowth
            ebitAdjusted
            ebitReported
            ebitda
            enterpriseValue
            epsAdjusted
            dividend
            dividendYield
            sharePrice
            nav
            navPerShare
            opexOfNav
            quarterlySharePrice
          }
        }
      }
      id
    }
    id
  }
}

fragment PriceAndRecommendation_Content on Content {
  __isContent: __typename
  createdAt
  companies {
    name
    pageUrl
    defaultInstrument {
      priceData {
        tradeCurrency
      }
      snapshot {
        priceData {
          date
          lastPrice
          tradeCurrency
        }
        transaction {
          date
          recommendation
          targetPrice
        }
        prevTransaction {
          recommendation
        }
      }
      id
    }
    id
  }
}

fragment PublishingDetails on Content {
  __isContent: __typename
  createdAt
  publishers {
    name
    imgUrl
  }
  authors {
    __typename
    id
    name
    slug
    imgUrl
    jobTitle
  }
  ... on Video {
    liveTime
  }
  ... on Webcast {
    liveTime
  }
}

fragment Reactions on Content {
  __isContent: __typename
  id
  reactionGroups {
    reactionType
    reactionsCount
    viewerReacted
  }
}

fragment ReportLink_Content on Content {
  __isContent: __typename
  type
  isPremium
  ... on CompanyReport {
    reportUrl
  }
  ... on ThirdPartyCompanyReport {
    reportUrl
  }
  ... on StockExchangeRelease {
    reportUrl
  }
}

fragment TrendingContent_1jQ2Cn on Query {
  trendingContent(type: ARTICLE) {
    __typename
    id
    title
    lang
    pageUrl
    createdAt
    type
    imgUrl
    companies {
      squareLogoUrl
      name
      id
    }
    authors {
      __typename
      imgUrl
      id
    }
    publishers {
      imgUrl
    }
  }
}


diamyd-medical-ab-diamyd-medical-fully-subscribes-to-its-pro-rata-share-in-nextcell-pharmas-rights-issue

__typename

title

isPremium

lang

htmlBody

summary

companies

createdAt

publishers

authors

reactionGroups

pageUrl

translations

imgUrl

description

Diamyd Medical is active in diabetes research. The company has developed a vaccine that contains the active ingredient and molecule GAD, a substance that has the potential to be an important part of the prevention of diabetes treatments in the future. The company has operations on a global level with the largest presence in the Nordic region. The headquarters are located in Stockholm.

The announcement will presumably contain the content of the DSMB meeting statement. The DSMB cannot make this conclusion in advance before the meeting. The only possibility is that the presentation material is ready ahead of schedule and an earlier time suits the DSMB members. In this case, the interim readout means that the data has been submitted to an independent party that prepares the presentation materials for the DSMB meeting.

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 genetically defined patient population.” The interim analysis is based on data from 174 evaluable participants. The primary endpoint of the interim analysis is change from baseline to Month 15 in stimulated C-peptide area under the curve (AUC), reflecting preservation of endogenous insulin production, and is intended to provide an assessment of treatment effect in the study population. In line with the company’s regulatory strategy, positive interim result would support engagement with regulatory authorities to discuss possible approval pathways for retogatein. The interim analysis will assess the efficacy of retogatein compared to placebo and test whether predefined criteria for statistical significance are met. An independent Data Safety Monitoring Board (DSMB) will review the interim result and accumulated safety data. The company intends to communicate the outcome of the DSMB meeting, including whether statistical significance was met for the primary endpoint, as well as an update on the DSMB’s safety assessment of the ongoing trial. DIAGNODE-3 is a randomized, double-blind, placebo-controlled confirmatory Phase 3 trial evaluating intralymphatic administration of retogatein formulated with alum in children, adolescents, and young adults newly diagnosed with Stage 3 type 1 diabetes who carry the HLA DR3-DQ2 haplotype. This genetic profile is present in approximately 40% of individuals with type 1 diabetes in Europe and the United States. The primary readout will be based on baseline to 15-month data for all randomized participants after which participants will continue to be followed for a total of 24 months. DIAGNODE-3 is expected to be fully randomized in mid-March 2026. DIAGNODE-3 is supported, in part, by funding from Breakthrough T1D (formerly JDRF), the leading global type 1 diabetes research and advocacy organization. Retogatein has received Fast Track Designation from the FDA for the treatment of type 1 diabetes across Stages 1–3, as well as Orphan Drug Designation for Stage 3 type 1 diabetes.                    diamyd.com              Diamyd Medical announces finalization of database for interim analysis in...                              Diamyd/DSMB has finalized the clinical database—in my interpretation, the concrete data for the interim results.  If I understand correctly, all data is now collected, entered, and awaiting unblinding by the DSMB. The press release confirms the previous rhetoric regarding timing: “expected by the end of March 2026” 174 evaluable participants → Sufficient for FDA requirements The interim results will be limited. Apparently no statistical figures or deep analysis. Just “whether the primary endpoint is met or not.”  Now we just wait for the results… I wonder if the results could be released well before the end of March if the DSMB gets them ready? As previously stated, in these interim results, the primary endpoint is only C-peptide. The final results will also include clinical metrics. In the case of Tzield, C-peptide improvement alone was not enough for final Stage 3 approval, as it failed to reduce the patient’s required insulin dose and HbA1c. It is reportedly now seeking temporary approval for Stage 3 using C-peptide as a surrogate. But the FDA’s reaction is uncertain: since the FDA already knows that the drug failed its secondary clinical goals on the first attempt, why should it be allowed through the C-peptide track along with Diamyd? However, the situation is brighter for Diamyd, and marketing authorization is possible with the interim results. Diamyd is only seeking a temporary accelerated marketing authorization based on C-peptide results to begin with, and the clinical results will be obtained later. Approval could therefore be granted early even if the clinical results eventually turn out to be a disappointment. This is possible because the safety profile is significantly better than Tzield’s. Additionally, Diamyd has good evidence of clinical results from previous phases. However, the criteria are high, meaning that achieving the endpoint does not guarantee approval based on interim results. If, however, Tzield gets accelerated approval for Stage 3… then the bar has been set very low.

Maybe being hooked up to IVs for two weeks and destroying the immune system isn’t very appealing. Jokes aside, the low sales are fully explained by the fact that at that stage, Tzield was only approved for Stage 2 treatment. In other words, for those who don’t yet have symptoms. That patient population is likely quite difficult to find. You can’t find them except through active screening, which is not yet common for T1D. There are pilots ongoing around the world for this, e.g., in the US, ASK (Autoimmunity Screening for Kids). And with Tzield being stuck at Stage 2, whose target group doesn’t yet know they need treatment, Sanofi has taken strong measures for sales promotion… they hired Usher.  Browsing through forum discussions, it seems that it might be available in a limited capacity for Stage 3 as well, but insurance companies have still been reluctant about any reimbursement during 2024.

Tzield sales are looking a bit sluggish, $16M in Q4 which was flat YoY. Perhaps this also tempers expectations for Diamyd.

Fortunately, Tzield’s added value was enough, despite a horrible two-week hospital stay with its side effects and the same efficacy + exorbitant price.  Yeah, and on top of that, lymphocyte depletion. And although the change observed during the Phase 2/3 study period is roughly in the same range as Diamyd, they shouldn’t necessarily be considered comparable. From what I understand, Tzield’s effect works by momentarily lobotomizing the lymphocytes. After such a “factory reset,” the new lymphocytes being born are somewhat less aggressive toward the beta cells, but the cells are still just as prone to radicalizing again, which is why the disease progresses. In Diamyd too, the disease progresses with the doses in the research pipeline, but the mechanism is different. Diamyd modulates the immune response and, in a way, provides desensitization therapy. Why the disease then still continues to progress, albeit more slowly, I don’t know exactly. But since the drug is safe, it can be injected more frequently. One explanation for the progression is the “Epitope Spreading” phenomenon, through which diabetes that has progressed too far is difficult to stop as the immune system starts to escalate, reacting also to markers other than the body’s own GAD65, where it all started. And at the point of diagnosis, the situation has already gotten out of hand (at the time of diagnosis, approx. 80% of cells have already been destroyed). At the same time, the remaining beta cells are overloaded. Thus, the GAD65 tolerance brought about by Diamyd slows down the disease but no longer stops it at a late stage. On the other hand, this doesn’t rule out the possibility that treatment started in the early stages, before the onset of the disease, could prevent this escalation entirely. For Tzield, I don’t see such a possibility. Yeah, apparently Tzield has gained quite good reimbursement coverage in the US, and in some places, it’s available without a deductible. It’s also covered under Medicare Part B, where one can get by with a 20% copay.  However, that wasn’t enough everywhere. For example, in Canada, no reimbursement is provided. The price for Tzield has been said to be around 200k, but that might not necessarily hold true as an average price. Apparently, the big pharma mafias negotiate large, shady discounts for expensive drugs with insurance companies to favor their own products. I don’t know if this applies to this drug since there are no competitors yet, but I’m under the impression that this practice is more the rule than the exception.

Wow, some hardcore analysis @Mauski. Relieving that even in bear scenarios, this is a multibagger   Fortunately, Tzield’s added value was enough, despite a horrific two-week hospital stay with side effects and the same efficacy + an outrageous price.

Uncommonly precise and sensible reflection. In some strange way, I have started following the trail. I can’t quite name the ultimate reason, but when successful, these are significant matters that ease a poor soul’s earthly journey. Perhaps that is the reason.

Diamyd Medical

Diamyd Medical is one of the main owners of NextCell Pharma with an ownership of 12.8%. NextCell Pharma is now carrying out a rights issue which, upon full subscription, will provide NextCell...

Diamyd Medical is one of the main owners of NextCell Pharma with an ownership of 12.8%. NextCell Pharma is now carrying out a rights issue which, upon full subscription, will provide NextCell with approximatelySEK 24.9 million before issue costs."We consolidate our holding in NextCell Pharma by fully participating with our share in the rights issue," says Ulf Hannelius, CEO of Diamyd Medical. "NextCell impresses with its pace of development and through the holding in NextCell we strategically monitor the diabetes therapies within the stem cell field."About NextCell Pharma Stem cells are expected to change the way how many of today's life-threatening diseases are treated. NextCellPharma AB develops ProTransTM, a drug candidate consisting of stem cells for the primary treatment of autoimmune and inflammatory diseases as well as for use in kidney transplants. ProTransTM consists of selected stem cells derived from the umbilical cord tissue with NextCell Pharma AB's proprietary method. In addition, the company has a service called Cellaviva, Sweden's first stem cell bank for the family-saving of stem cells from umbilical cord blood and umbilical cord tissueAbout Diamyd Medical Diamyd Medical develops the diabetes vaccine Diamyd®, as an antigen-specific immunotherapy for the preservation of endogenous insulin production. Diamyd® has demonstrated good safety in trials encompassing more than 1,000 patients as well as effect in some pre-specified subgroups. Besides the Company's own European Phase-IIb trial DIAGNODE-2 where the diabetes vaccine is administered directly into a lymph node, three investigator initiated clinical trials are ongoing with Diamyd®. Diamyd Medical also develops the GABA-based investigational drug Remygen® for regeneration of endogenous insulin production. An investigator-initiated Remygen® trial in patients living with type 1 diabetes for more than five years is ongoing at Uppsala University Hospital. An investigator-initiated trial with GABA and Diamyd® in patients recently diagnosed with type 1 diabetes is also ongoing at the University of Alabama at Birmingham, USA. Diamyd Medical is one of the major shareholders in the stem cell company NextCell Pharma AB and has holdings in the medtech company Companion Medical, Inc., San Diego, USA.Diamyd Medical's B-share is traded on Nasdaq First North under the ticker DMYD B. FNCA Sweden AB is the Company's Certified Adviser; phone: +46 8-528 00 399, e-mail: <virtloc>info@fnca.se </virtloc>