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
    }
  }
}


ascelia-pharma-orviglance-nda-submitted-and-cash-runway-extended-into-2026-during-q3-2025

__typename

title

isPremium

lang

htmlBody

summary

companies

createdAt

publishers

authors

reactionGroups

pageUrl

translations

imgUrl

description

Equity Research Analyst

Philip Coombes

Ascelia Pharma is a Swedish biotech company with a focus on orphan oncology treatments. They develop and commercialize novel drugs that address unmet medical needs and have a clear development and market pathway. Currently, Ascelia pharma has two pipeline products, namely Orviglance and Oncoral. Orviglance is a novel contrast agent for MR-Imaging developed to improve the detecting and visualization of focal liver lesions (Including liver metastases – and primary tumors) in patients with reduced kidney function. Oncoral is a daily tablet with an established potent anti-tumor effect – even in difficult to treat cancers with the potential to offer better patient outcomes with improved safety following a daily tablet treatment compared to intravenous high-dose infusions at the hospital.

Ascelia Pharma is listed on Nasdaq Small Cap Stockholm with ticker ACE.

Ascelia Pharma

This morning, Ascelia Pharma (ACE) published its Q3 2025 results, marking a milestone quarter with the submission of the New Drug Application (NDA) for Orviglance to the US FDA in early September. The submission follows a successful clinical program, including the pivotal SPARKLE Phase 3 trial. The NDA will undergo a standard 10-month FDA review, with an expected PDUFA decision in Q3 2026.

This morning, Ascelia Pharma (ACE) published its Q3 2025 results, marking a milestone quarter with the submission of the New Drug Application (NDA) for Orviglance to the US FDA in early September. The submission follows a successful clinical program, including the pivotal SPARKLE Phase 3 trial, which demonstrated statistically significant improvements in liver lesion visualization. The NDA will undergo a standard 10-month FDA review, with an expected PDUFA decision in Q3 2026.
During the quarter, Ascelia strengthened its balance sheet through Fenja Capital&#x2019;s SEK 7.5m convertible conversion and a SEK 30m directed share issue, extending the cash runway into Q4 2026&#x2014;well beyond the expected FDA decision. The company reported an operating loss of SEK &#x2013;15.3m (&#x2013;17.8m) and liquid assets of SEK 72.3m at quarter-end.
Management continues partnering discussions for the commercialization of Orviglance and has announced leadership adjustments post-period to support future growth and execution through the regulatory review.
Tomorrow on 6 November 2025 at 12:00 CET Ascelia Pharma Deputy CEO and CCO Julie Waras Brogren will present the financial results for the first nine months of 2025. Link: https://www.inderes.dk/videos/ascelia-pharma-presentation-of-interim-q3-2025-report Disclaimer: HC Andersen Capital receives payment from Ascelia Pharma for a DigitalIR/Corporate Visibility subscription agreement. / Philip Coombes 08:27 05/11/2025

HC Andersen Capital

<ul><li>Ascelia Pharma har indsendt en New Drug Application (NDA) for Orviglance til den amerikanske FDA, med en forventet PDUFA-beslutning i Q3 2026 efter en 10-måneders gennemgang.</li><li>Virksomheden har styrket sin balance med en SEK 7,5 mio. konvertering fra Fenja Capital og en SEK 30 mio. rettet aktieemission, hvilket forlænger likviditeten til Q4 2026.</li><li>Ascelia rapporterede et driftsunderskud på SEK –15,3 mio. og likvide midler på SEK 72,3 mio. ved kvartalets afslutning.</li><li>Ledelsen fortsætter partnerskabsdiskussioner for kommercialisering af Orviglance og har annonceret ledelsesændringer for at støtte fremtidig vækst.</li></ul>Dette indhold er genereret af AI. Du kan give feedback om det på Inderes <a href="https://forum.inderes.com/t/inderes-fi-sisallon-kehitysideat/71/last">forum</a>.

Ascelia Pharma: Orviglance NDA submitted and cash runway extended into 2026 during Q3 2025

Summary