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2024-05-08 | Penser Access by Carnegie | Penser Access by Carnegie: Ascelia Pharma: Medvind i seglen | Pressreleaser | Visa Stäng |
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2024-05-07 | Ascelia Pharma | Welcome to Ascelia Pharma Investor Update: Bringing Orviglance to Patients | Pressreleaser | Ladda ner | Visa Stäng |
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2024-05-07 | Ascelia Pharma | Välkommen till Ascelia Pharma uppdatering till investerare: Att föra Orviglance till patienterna | Pressreleaser | Ladda ner | Visa Stäng |
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2024-05-06 | Ascelia Pharma | Kommuniké från årsstämma den 6 maj 2024 i Ascelia Pharma AB | Pressreleaser | Ladda ner | Visa Stäng |
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2024-05-06 | Ascelia Pharma | Bulletin from the Annual General Meeting in Ascelia Pharma AB on 6 May 2024 | Pressreleaser | Ladda ner | Visa Stäng |
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2024-05-02 | Ascelia Pharma | Ascelia Pharma uppnår framgångsrikt det primära effektmåttet med starka headline-resultat i fas 3-studien med Orviglance | Pressreleaser | Ladda ner | Visa Stäng |
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2024-05-02 | Ascelia Pharma | Ascelia Pharma Successfully Meets Primary Endpoint with Strong Headline Results in Orviglance Phase 3 Study | Pressreleaser | Ladda ner | Visa Stäng |
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2024-04-18 | Ascelia Pharma | Ascelia Pharma Draws Down SEK 15 Million Second Tranche Under Existing Loan Facility | Pressreleaser | Ladda ner | Visa Stäng |
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2024-04-18 | Ascelia Pharma | Ascelia Pharma utnyttjar den andra tranchen om 15 MSEK under befintlig lånefacilitet | Pressreleaser | Ladda ner | Visa Stäng |
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2024-04-10 | Ascelia Pharma | Ascelia Pharma rapporterar att SPARKLE-bildläsningsfasen är avslutad och förväntar sig headline-resultat i första halvan av maj 2024 | Pressreleaser | Ladda ner | Visa Stäng |
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2024-04-10 | Ascelia Pharma | Ascelia Pharma Reports SPARKLE Image Reading Completion and Expects Headline Results First Half of May 2024 | Pressreleaser | Ladda ner | Visa Stäng |
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2024-04-08 | Ascelia Pharma | Årsredovisning 2023: Solida framsteg med slutförd patientrekrytering till Orviglance fas 3 och förväntat headline-resultat i maj 2024 | Rapporter | Ladda ner | Visa Stäng |
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2024-04-08 | Ascelia Pharma | Annual Report 2023: Solid Progress with Orviglance Phase 3 Patient Recruitment Completed and Headline Results Expected by May 2024 | Rapporter | Ladda ner | Visa Stäng |
Rapporter |
Annual Report 2023: Solid Progress with Orviglance Phase 3 Patient Recruitment Completed and Headline Results Expected by May 2024The English text is an unofficial translation. In case of any discrepancies between the Swedish text and the English translation, the Swedish text shall prevail. Ascelia Pharma AB (publ) (ticker: ACE) today published its Annual Report 2023, which is now available on the company’s website: https://www.ascelia.com/ir-media/financial-reports/ Magnus Corfitzen, CEO, Ascelia Pharma, says: “In 2023, our focus was on SPARKLE, the pivotal Phase 3 study for our orphan magnetic resonance imaging (MRI) contrast agent for liver imaging, Orviglance®. We successfully completed patient enrollment in March. In early August, the unexpected discovery of high intra-reader variability in the study image scoring by independent radiologists prevented us from evaluating the efficacy data from SPARKLE. Therefore, a new evaluation of the images with new independent readers was required. With the aim of reaching headline results with available funding, we focused all resources on the re-evaluation and implemented cost-cutting initiatives, including a significant reduction of the organization. In September, we shared our plan to complete the re-evaluation and reach headline results from SPARKLE by May 2024. In addition, we expanded the commercialization strategy for Orviglance to also consider launching in the US with a partner. Early December, we communicated that the image reading process had started according to plan, keeping us on track for the May 2024 headline results. While the re-evaluation was a regrettable setback on our timelines, it does not change our confidence in Orviglance, nor does it change the global medical need for a liver imaging contrast agent without gadolinium. On 4 February 2024, we were pleased to announce that we secured a directed issue of convertibles raising gross proceeds of SEK 15 million and an agreement for a loan facility of up to SEK 20 million, extending our cash runway into Q2 2025 with the full financing. This strengthened financial position is an important and value-adding step to maintain financial and strategic flexibility. We are also very pleased to be able to secure a financing solution with a maximum dilution of only around 4 percent for our shareholders. We look very much forward to executing on the opportunities ahead for Ascelia Pharma in 2024 and beyond – starting with the announcement of headline results by May.” |
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2024-03-27 | Ascelia Pharma | Kallelse till årsstämma i Ascelia Pharma AB | Pressreleaser | Ladda ner | Visa Stäng |
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2024-03-27 | Ascelia Pharma | Notice of Annual General Meeting in Ascelia Pharma AB | Pressreleaser | Ladda ner | Visa Stäng |
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2024-02-21 | Penser Access by Carnegie | Penser Access by Carnegie: Interview with Ascelia Pharma - Carnegie Investment Bank - Feb 21th 2024 | Pressreleaser | Visa Stäng |
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2024-02-12 | Penser Access by Carnegie | Penser Access by Carnegie: Ascelia Pharma - Finansiering på plats, avgörande data i maj | Pressreleaser | Visa Stäng |
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2024-02-12 | Redeye | Redeye: Ascelia Pharma Q4 2023 - On track with easing financial pressure | Pressreleaser | Ladda ner | Visa Stäng |
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2024-02-09 | Ascelia Pharma | Q4 och bokslutskommuniké 2023: Stärkt finansiell position inför headline-resultat i maj för den kliniska fas-3 studien SPARKLE | Rapporter | Ladda ner | Visa Stäng |
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2024-02-09 | Ascelia Pharma | Q4 and Full Year Report 2023: Strengthened Financial Position Ahead of SPARKLE Phase 3 Study Headline Results in May | Rapporter | Ladda ner | Visa Stäng |
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2024-02-04 | Ascelia Pharma | Ascelia Pharma säkrar finansiering om upp till 35 MSEK | Pressreleaser | Ladda ner | Visa Stäng |
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2024-02-04 | Ascelia Pharma | Ascelia Pharma Secures Financing of up to SEK 35 Million | Pressreleaser | Ladda ner | Visa Stäng |
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2024-01-24 | Ascelia Pharma | Orviglance Review Article Published in Investigative Radiology | Pressreleaser | Ladda ner | Visa Stäng |
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2024-01-24 | Ascelia Pharma | Översiktsartikel om Orviglance publicerad i Investigative Radiology | Pressreleaser | Ladda ner | Visa Stäng |
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2024-01-24 | Ascelia Pharma | Nomination Committee Appointed for AGM 2024 in Ascelia Pharma AB | Pressreleaser | Ladda ner | Visa Stäng |
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2024-01-24 | Ascelia Pharma | Valberedning utsedd i Ascelia Pharma AB inför årsstämman 2024 | Pressreleaser | Ladda ner | Visa Stäng |
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2023-12-07 | Ascelia Pharma | Ascelia Pharma meddelar start av bildläsningsfasen och bekräftar resultat från fas 3 SPARKLE senast i maj 2024 | Pressreleaser | Ladda ner | Visa Stäng |
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2023-12-07 | Ascelia Pharma | Ascelia Pharma Announces Start of Image Reading Phase and Re-confirms Phase 3 SPARKLE Results by May 2024 | Pressreleaser | Ladda ner | Visa Stäng |
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2023-12-06 | Finansinspektionen | Finansinspektionen: Flaggningsmeddelande i Ascelia Pharma AB | Pressreleaser | Visa Stäng |
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2023-11-30 | Ascelia Pharma | Ändring av antalet aktier och röster i Ascelia Pharma AB | Pressreleaser | Ladda ner | Visa Stäng |
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2023-11-30 | Ascelia Pharma | Change in Number of Shares and Votes in Ascelia Pharma AB | Pressreleaser | Ladda ner | Visa Stäng |
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2023-11-13 | Ascelia Pharma | Bulletin from the Extraordinary General Meeting in Ascelia Pharma AB on 13 November 2023 | Pressreleaser | Ladda ner | Visa Stäng |
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2023-11-13 | Ascelia Pharma | Kommuniké från extra bolagsstämma den 13 november 2023 i Ascelia Pharma AB | Pressreleaser | Ladda ner | Visa Stäng |
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2023-11-09 | Ascelia Pharma | Ascelia Pharma beslutar om omvandling av C-aktier till stamaktier för leverans till deltagare i incitaments-program | Pressreleaser | Ladda ner | Visa Stäng |
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2023-11-09 | Ascelia Pharma | Ascelia Pharma resolves on conversion of series C shares into ordinary shares for delivery to participants in incentive program | Pressreleaser | Ladda ner | Visa Stäng |
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2023-11-09 | Penser Access | Penser Access: Blickarna mot maj - Ascelia Pharma | Pressreleaser | Visa Stäng |
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2023-11-09 | Redeye | Redeye: Ascelia Q3 update - On track for a SPARKLE result in May 2024 | Pressreleaser | Ladda ner | Visa Stäng |
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2023-11-08 | Ascelia Pharma | QUARTERLY REPORT Q3 2023: Re-evaluation of SPARKLE Phase 3 Study Images Progresses According to Plan | Rapporter | Ladda ner | Visa Stäng |
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2023-11-08 | Ascelia Pharma | KVARTALSRAPPORT Q3 2022: Den ny utläsning av bilderna från fas 3-studien SPARKLE fortskrider enligt planen | Rapporter | Ladda ner | Visa Stäng |
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2023-10-19 | Ascelia Pharma | NOTICE OF EXTRAORDINARY GENERAL MEETING IN ASCELIA PHARMA AB | Pressreleaser | Ladda ner | Visa Stäng |
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2023-10-19 | Ascelia Pharma | KALLELSE TILL EXTRA BOLAGSSTÄMMA I ASCELIA PHARMA AB | Pressreleaser | Ladda ner | Visa Stäng |
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2023-10-04 | Ascelia Pharma | Ascelia Pharma Gets Acceptance for Publication of Orviglance Review Article in Investigative Radiology | Pressreleaser | Ladda ner | Visa Stäng |
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2023-10-04 | Ascelia Pharma | Ascelia Pharma får översiktsartikel om Orviglance accepterad för publicering i Investigative Radiology | Pressreleaser | Ladda ner | Visa Stäng |
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2023-09-18 | Redeye | Redeye: Ascelia Pharma - All attention on the top priority | Pressreleaser | Ladda ner | Visa Stäng |
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2023-09-13 | Ascelia Pharma | Ascelia Pharma når headline-resultat från SPARKLE-utläsningen i maj 2024 med nuvarande finansiering | Pressreleaser | Ladda ner | Visa Stäng |
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2023-09-13 | Ascelia Pharma | Ascelia Pharma to Reach Headline Results from SPARKLE Re-Evaluation by May 2024 with Current Funding | Pressreleaser | Ladda ner | Visa Stäng |
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2023-08-31 | Ascelia Pharma | Ascelia Pharma significantly reduces organization to reach SPARKLE headline results | Pressreleaser | Ladda ner | Visa Stäng |
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2023-08-31 | Ascelia Pharma | Ascelia Pharma gör omfattande neddragning av organisationen för att nå headline-resultat med SPARKLE | Pressreleaser | Ladda ner | Visa Stäng |
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2023-08-21 | Penser Access | Penser Access: I väntan på nästa milstolpe - Ascelia Pharma | Pressreleaser | Visa Stäng |
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2023-08-18 | Ascelia Pharma | Halvårsrapport 2023: Ny utläsning krävs efter intraläsarinkonsistens rörande poängsättning av bilder av läsare från fas 3-studien SPARKLE | Rapporter | Ladda ner | Visa Stäng |
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2023-08-18 | Ascelia Pharma | Half-Year report 2023: Re-evaluation required after intra-reader inconsistency in scoring of images from phase 3 study SPARKLE | Rapporter | Ladda ner | Visa Stäng |
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2023-08-09 | Ascelia Pharma | Ascelia Pharma ger förtydliganden kring intraläsarvariabilitet vid utläsningen av bilder i SPARKLE-studien | Pressreleaser | Ladda ner | Visa Stäng |
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2023-08-09 | Ascelia Pharma | Ascelia Pharma provides clarifications around the intra-reader variability in read-out of images in the SPARKLE study | Pressreleaser | Ladda ner | Visa Stäng |
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2023-08-09 | Penser Access | Penser Access: Oväntat utfall - Ascelia Pharma | Pressreleaser | Visa Stäng |
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2023-08-09 | Redeye | Redeye: Ascelia Pharma - SPARKLE is blurred | Pressreleaser | Ladda ner | Visa Stäng |
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2023-08-07 | Ascelia Pharma | Re-Evaluation Required After Intra-Reader Inconsistency in Scoring of Images from Phase 3 Study SPARKLE | Pressreleaser | Ladda ner | Visa Stäng |
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2023-08-07 | Ascelia Pharma | Ny utläsning krävs efter intraläsarinkonsistens rörande poängsättning av bilder av läsare från fas 3-studien SPARKLE | Pressreleaser | Ladda ner | Visa Stäng |
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2023-06-20 | Penser Access | Penser Access: Sanningens ögonblick - Ascelia Pharma | Pressreleaser | Visa Stäng |
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2023-06-16 | Ascelia Pharma | Ascelia Pharma presented Orviglance Hepatic Impairment Data and hosted a Q&A with liver imaging experts at the 2023 ESGAR Annual Meeting | Pressreleaser | Ladda ner | Visa Stäng |
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2023-06-16 | Ascelia Pharma | Vid ESGARs årsmöte 2023 presenterade Ascelia Pharma Orviglance-data från studien med nedsatt leverfunktion samt var värd för en Q&A med experter inom leveravbildning | Pressreleaser | Ladda ner | Visa Stäng |
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2023-05-15 | Redeye | Redeye: Ascelia Pharma - SPARKLE is about to sparkle | Pressreleaser | Ladda ner | Visa Stäng |
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2023-05-12 | Penser Access | Penser Access: Nyckelhändelse stundar - Ascelia Pharma | Pressreleaser | Visa Stäng |
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2023-05-11 | Ascelia Pharma | KVARTALSRAPPORT Q1 2023: Fas 3 studien för Orviglance, SPARKLE, sista patientens sista besök (Last Patient Last Visit, LPLV) har avslutats | Rapporter | Ladda ner | Visa Stäng |
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2023-05-11 | Ascelia Pharma | QUARTERLY REPORT Q1 2023: Orviglance phase 3 study, SPARKLE, Last Patient Last Visit (LPLV) has been completed | Rapporter | Ladda ner | Visa Stäng |
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