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
          }
          estimates {
            year
            quarter
            revenue
            revenueGrowth
            ebitAdjusted
            ebitReported
            ebitda
            enterpriseValue
            epsAdjusted
            dividend
            dividendYield
            sharePrice
          }
        }
      }
      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
    }
  }
}


fda-sets-pdufa-date-for-xspray-pharmas-re-submitted-application-for-dasynocr

__typename

title

isPremium

lang

htmlBody

summary

companies

createdAt

publishers

authors

reactionGroups

pageUrl

translations

imgUrl

description

Xspray Pharma is a pharmaceutical company with several product candidates in clinical development that uses the patented HyNap technology to create improved versions of marketed protein kinase inhibitors. The drug candidate Dasynoc® is an amorphous form of dasatinib and is undergoing FDA review for market approval. Xspray Pharma's product portfolio also includes XS003-nilotinib, XS008-axitinib and XS025-cabozantinib.

Xspray Pharma

The U.S. Food and Drug Administration (FDA) has acknowledged receipt of Xspray Pharma's re-submitted NDA (New Drug Application) for Dasynoc®. The re-submission is based on a CRL (Complete Response...

<div class="mfn-preamble"><p><strong>The U.S. Food and Drug Administration (FDA) has acknowledged receipt of Xspray Pharma's re-submitted NDA (New Drug Application) for Dasynoc®. The re-submission is based on a CRL (Complete Response Letter) received from the FDA in July 2024 where additional information was requested. The FDA has now set the PDUFA date to 7 October 2025, which is the FDA's deadline for communicating its decision on the company's application. Xspray Pharma is now continuing to prepare for the US launch of Dasynoc® with the aim that it can begin as soon as possible if market approval is received in October.</strong></p></div><div class="mfn-body"><p>“I am pleased that we now have a PDUFA date, and with that date now set we continue to prepare for a successful launch of Dasynoc® as soon as we receive market approval. At such point we will be ready to offer ALL and CML patients in the US Dasynoc, a dasatinib drug with important advantages compared to today's treatment options,” says Per Andersson, CEO of Xspray Pharma.</p><p>The acknowledgement from the FDA was received a week after the FDA was expected to communicate a PDUFA date, but the Authority did not specify a reason for the delay.</p></div><div class="mfn-footer mfn-contacts mfn-3ba176259f98"><p><strong class="mfn-heading-1">For further information, please contact:</strong></p><hr><p>Jacob Nyberg, IR<br>Xspray Pharma AB (publ)<br>Tel: + 46 (0) 70 767 08 83<br>E-mail: ir@xspray.com</p></div><div class="mfn-footer mfn-about mfn-18f9cb4c3bed"><p><strong class="mfn-heading-1">About Xspray Pharma</strong></p><hr><p>Xspray Pharma AB (publ) is a pharmaceutical company with several product candidates in clinical development utilizing its innovative, patented HyNap™ technology platform to create improved versions of marketed protein kinase inhibitors (PKI), the largest oncology market segment, often with high drug prices. The company’s goal is to become the market leader in improved PKI’s for cancer treatment. Xspray Pharma's lead drug candidate, Dasynoc®, is currently undergoing FDA review. It is an amorphous form of dasatinib, demonstrating bioequivalence at a 30% lower dose due to a better solubility profile. Its compatibility with proton pump inhibitors (PPIs), which are often co-prescribed to patients with CML and ALL, is a significant advantage. Xspray Pharma is building a robust product portfolio, including XS003-nilotinib (an optimized version of Tasigna®) and XS008-axitinib (an optimized version of Inlyta®) and XS025-cabozantinib (an optimized version of Cabometyx®).</p><p>The Xspray Pharma AB-share is trading at Nasdaq Stockholm (Nasdaq Stockholm: XSPRAY).<br>www.xspraypharma.com.</p></div><div class="mfn-footer mfn-regulatory mfn-regulatory-mar"><p><em>This information is information that Xspray Pharma AB 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 2025-05-14 21:10 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/5b60bfd0-bbac-47aa-bb56-ffae6bed3454/fda-sets-pdufa-date-for-xspray-pharmas-re-submitted-application-for-dasynoc-r.pdf" class="mfn-generated mfn-primary">FDA sets PDUFA-date for Xspray Pharma's re-submitted application for Dasynoc®</a></p></div>