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 {
    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
    }
  }
}


xbrane-re-submits-bla-for-ranibizumab-biosimilar-candidate-to-fda

__typename

title

isPremium

lang

htmlBody

companies

createdAt

publishers

authors

reactionGroups

pageUrl

alternatePageUrls

imgUrl

description

Xbrane Biopharma is a biotechnology company. The company specializes in research and development of drugs for the treatment of critical illnesses. Today, the business is focused on research in microspherical technology and in the development of protein molecules. The products are used in the treatment of prostate cancer and endometriosis, as well as in rare and serious eye diseases. The company's head office is located in Solna.

Xbrane Biopharma

Xbrane Biopharma AB (publ) ("Xbrane" or "the Company") (Nasdaq Stockholm: XBRANE) has re-submitted the BLA (Biologics License Application) for its investigational biosimilar candidate to LUCENTIS...

<div class="mfn-preamble"><p><strong>Xbrane Biopharma AB (publ) ("Xbrane" or "the Company") (Nasdaq Stockholm: XBRANE) has re-submitted the BLA (Biologics License Application) for its investigational biosimilar candidate to LUCENTIS® (ranibizumab) to FDA (US Food and Drug Administration).</strong></p></div><div class="mfn-body"><p>Xbrane submitted the BLA for its investigational biosimilar candidate to LUCENTIS® (ranibizumab) to the FDA in April 2023 and subsequently received a Complete Response Letter (CRL) in April 2024. In the CRL FDA requested additional information related to the reference standard and follow-up actions from the pre-approval inspections of manufacturing partners’ sites. Xbrane has since, after alignment with FDA, qualified a new reference standard and worked together with its manufacturing partners to complete the requested follow-up actions. The review cycle of a re-submitted BLA is typically 6 months.</p><p>Xbrane is fully committed to advance its investigational biosimilar candidate towards approval in the United States as quickly as possible to provide a much needed, cost-efficient treatment alternative for patients suffering from Age-related Macular Degeneration (AMD), retinal vein occlusion (RVO) or myopic choroidal neovascularization (mCNV).</p><p>LUCENTIS® is a registered trademark of Genentech Inc.</p></div><div class="mfn-footer mfn-contacts mfn-a61f5cf72e83"><p><strong class="mfn-heading-1">Contacts</strong></p><hr><p>Martin Åmark, CEO<br>E: <a rel="noopener" href="mailto:martin.amark@xbrane.com">martin.amark@xbrane.com</a></p><p>Anette Lindqvist, CFO/IR <br>E: <a rel="noopener" href="mailto:anette.lindqvist@xbrane.com">anette.lindqvist@xbrane.com</a></p></div><div class="mfn-footer mfn-about mfn-1cc8f17c2be2"><p><strong class="mfn-heading-1">About Us</strong></p><hr><p>Xbrane Biopharma AB develops biological drugs based on a patented platform technology that provides significantly lower production costs compared to competing systems. Xbrane has a portfolio of biosimilar candidates targeting EUR 26 billion in estimated annual peak sales of the respective reference product. The lead candidate Ximluci® is granted market authorization approval in Europe and was launched during 2023. Xbrane’s head office is in Solna, just outside Stockholm. Xbrane is listed on Nasdaq Stockholm under the ticker XBRANE. For more information, visit&nbsp;<a rel="noopener" href="http://www.xbrane.com">www.xbrane.com </a>&nbsp;<br></p></div><div class="mfn-footer mfn-regulatory mfn-regulatory-mar"><p><em>This information is information that Xbrane Biopharma is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 2024-12-31 09:00 CET.</em></p></div><div class="mfn-footer mfn-attachment mfn-attachment-general"><p><strong class="mfn-heading-1">Attachments</strong></p><hr><p><a rel="noopener" href="https://storage.mfn.se/c597aab8-f93b-409b-9a38-24d0fceac0f3/xbrane-re-submits-bla-for-ranibizumab-biosimilar-candidate-to-fda.pdf" class="mfn-generated mfn-primary">XBRANE RE-SUBMITS BLA FOR RANIBIZUMAB BIOSIMILAR CANDIDATE TO FDA</a></p></div>