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-provides-update-on-timing-of-re-submission-of-bla-for-ranibizumab-biosimilar-candidate

__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

Stockholm/Bad Vilbel/New York – In April 2024 Xbrane Biopharma AB (“Xbrane”) received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its Biologics...

<div class="mfn-preamble"><p><strong>Stockholm/Bad Vilbel/New York – In April 2024 Xbrane Biopharma AB (“Xbrane”) received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its Biologics License Application (BLA) for its ranibizumab biosimilar candidate (development name Xlucane™) for treatment of retinal disorders.</strong></p></div><div class="mfn-body"><p>FDA requested additional information primarily related to the reference standard and follow-up actions from the pre-approval inspections of manufacturing partners’ sites.</p><p>Xbrane has since communicated with FDA, and is working together with its partners, including US license holder Valorum Biologics, on addressing the respective requests. Xbrane has the ambition to re-submit the BLA in the fourth quarter of 2024. Should this submission be successful, this would result in a BsUFA date during the second quarter of 2025 assuming a standard 6 month review process and ongoing alignment with the FDA, as well as successful execution of remediation plans of the manufacturing partners.</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 2024-07-08 13:00 CEST.</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/968cd832-9fff-4c29-bd7a-bc1e08c355bc/xbrane-provides-update-on-timing-of-re-submission-of-bla-for-ranibizumab-biosimilar-candidate.pdf" class="mfn-generated mfn-primary">Xbrane Provides update on timing of re-submission of BLA for ranibizumab biosimilar candidate</a></p></div>

Xbrane Provides update on timing of re-submission of BLA for ranibizumab biosimilar candidate

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