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 CompanyTagList on Company {
  pageUrl
  name
  viewerIsFollowing
}

fragment ContentBasicInfo on Content {
  __isContent: __typename
  id
  type
  title
  lang
  companies {
    ...CompanyTagList
    id
  }
  ...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
    companies {
      forum {
        latestPosts {
          ...ForumPosts
        }
      }
      defaultInstrument {
        isin
        id
      }
      id
    }
    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
          }
          estimates {
            year
            quarter
            revenue
            revenueGrowth
            ebitAdjusted
            ebitReported
            ebitda
            enterpriseValue
            epsAdjusted
            dividend
            dividendYield
            sharePrice
          }
        }
      }
      id
    }
    id
  }
}

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


bioporto-potential-for-labelling-expansion-of-ngal-test

__typename

title

isPremium

lang

htmlBody

companies

createdAt

publishers

authors

reactionGroups

pageUrl

translations

imgUrl

description

CEO, Sweden

Claus Thestrup

Equity Research Analyst

Henrik Ekman

BioPorto is a Danish in-vitro diagnostics company with headquarters in Copenhagen, Denmark. The company was founded in 2000. BioPorto has one marketed product, the NGAL test, for early diagnosis of acute kidney injury (AKI), which is commercially available in Europe, Canada, Asia, and Israel.

It has received breakthrough designation from the FDA for AKI in the pediatric indication, for which it is currently conducting data analysis following the completion of enrollment of patients for its Phase 3 study which will lead to an expected application to FDA. Future plans include further FDA submission for adult indication as well as other markets. 

Hej Andreas, Jeg kan godt forstår, at det kan være svært at holde hoved og hale på det hele. Det er ikke unormalt i en godkendelsesproces med myndighederne.  Det er en dynamisk proces og der er ingen endelig dato for hvornår FDA kommer med et endeligt svar.  Selskabet har dog bekræftet flere gange, at man har en god dialog med FDA.  Håber det giver en smule mere indsigt i hvad der sker.

Har I noget overblik over deres tidslinje for ansøgningen ved FDA - Efter ændringen og spørgsmål fra FDA, så kan jeg ikke længere finde hoved og hale i hvornår FDA bør komme med den afgørelse?

BioPorto præsenterede i går deres Q3 regnskab i samarbejde med HC Andersen Capital. Der blev snakket om alt fra nøgletallene fra det seneste kvartal til hvordan deres dataindsamling fungerede. Tænker I at deres gode kursudvikling vil fortsætte mod årsskiftet?

Husk at læse hele vores research disclaimer på https://www.inderes.dk/disclaimer. Dansk:  BioPorto er et dansk In-vitro diagnostisk (IVD) selskab med hovedkontor i København, Danmark. Selskabet blev grundlagt i 2000. BioPorto har allerede ét produkt på markedet, NGAL-testen, som er til tidlig diagnosticering af akutte nyreskade (AKI). Den er kommercielt tilgængelig i Europa, Canada, Asien og Israel. NGAL-testen har modtaget banebrydende betegnelser fra FDA for akutte nyreskader til babyer, børn og unge under 18 år for hvilken den i øjeblikket udfører dataanalyser efter afslutningen af indrulning af patienter til dets fase 3-studie, som vil føre til en ansøgning til FDA. Fremtidige planer inkluderer yderligere FDA-indsendelse til voksenindikation såvel som andre markeder. English:  BioPorto is a Danish in-vitro diagnostics company with headquarters in Copenhagen, Denmark. The company was founded in 2000. BioPorto has one marketed product, the NGAL test, for early diagnosis of acute kidney injury (AKI), which is commercially available in Europe, Canada, Asia, and Israel.  It has received breakthrough designation from the FDA for AKI in the pediatric indication, for which it is currently conducting data analysis following the completion of enrollment of patients for its Phase 3 study which will lead to an expected application to FDA. Future plans include further FDA submission for an adult indication as well as other markets.

BioPorto

BioPorto's strategi includes labelling expansion 

BioPorto published interesting news July the 17th. regarding a new meta-analysis of NGAL in UTI (Urinary Tract Infection). The analysis based on 25 studies with more than 2,900 patients confirms that urine NGAL (uNGAL) could be highly accurate biomarker for UTI detection. The review is published by &#x201c;Frontiers in Pediatrics&#x201d; an organization specialized in pediatric&#xa0;patient care and&#xa0;child&#xa0;health. The review highlighted the high sensitivity (96%) and specificity (97%) of uNGAL, indicating a rapid and accurate alternative to current diagnostic methods for UTI. A urinary tract infection is&#xa0;a very common type of infection in your urinary system with more than 400 million global cases annually.
CEO Peter M&#xf8;rch Eriksen gave the following comment: &#x201c;The findings of the review are indeed encouraging for BioPorto. While further prospective studies to validate and confirm the use of uNGAL as a biomarker in UTI are required, they highlight the uniqueness of NGAL as a biomarker and the label expansion potential for our NGAL Test in areas other than AKI. BioPorto&#x2019;s focus is on the commercial launch of ProNephro AKI (NGAL) in the US and pending US clinical studies for an adult FDA indication of ProNephro AKI (NGAL), but we will consider how results from the review align with the company&#x2019;s strategy for label expansion of NGAL assays.&#x201d;
We host an event with BioPorto August 15th. at 10:30 &#x2013; sign up here: <a href="https://www.inderes.dk/videos/bioporto-opdatering-pa-q2-2024" target="_blank" rel="noopener">Bioporto Q2 event</a>
Disclaimer: HC Andersen Capital receives payment from BioPorto for a Digital IR/Corporate Visibility subscription agreement. /Claus Thestrup 11:15 AM 08-08-2024