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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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Welcome to Ascelia Pharma Investor Update: Bringing Orviglance to PatientsAscelia Pharma AB (publ) (ticker: ACE), a biotech focused on improving the life of people living with rare cancer conditions, today welcomes investors, analysts and media to the virtual update and live Q&A, where executive management further explains the strong Phase 3 headline results and plans for the upcoming regulatory and commercialization activities. Presentations are available on the Company’s website and the live Q&A starts on Tuesday, 7 May at 14:00 CEST. The online presentations and live event are available from this link and on the company’s website ( www.ascelia.com ). These positive headline results from SPARKLE conclude clinical development of Orviglance with consistent positive efficacy and safety data from nine clinical studies with a total of 286 patients and healthy volunteers. The Company will now focus on bringing Orviglance through the regulatory submission and approval process. In parallel, we will continue to advance launch readiness and dialogue with potential commercialization partners to make Orviglance available to patients who need high-quality liver imaging without gadolinium-related safety risk. In the Investor Update executive management:
The following presentations are available in the Investor Update online : Our objective is to reach a timely submission and approval by the US FDA as an orphan drug with an optimal label for use in the target population. As we move our focus to the regulatory submission and approval, we will in parallel continue to advance launch readiness and our dialogue with potential commercialization partners, “Ascelia has met another major milestone, and we look forward to meeting the next milestones on our journey to making Orviglance available to patients and transforming Ascelia to a commercial stage company”, he says. The Company expects to submit the NDA file for FDA regulatory approval by mid-2025. The focus of the Company is now on completing preparations required prior to submission. These include:
Progress Commercialization Readiness The strategy, based on extensive market research, is in place for a focused, ambitious launch for a well-defined vulnerable patient population. The focus ahead is to progress launch readiness and establish commercial partnerships. “Our commercialization strategy is to launch through partners with the potential for an Ascelia Pharma led launch in the US. The overall ambition is to secure the optimal balance between value creation, investment required and future revenues”, she says. |
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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 Reports SPARKLE Image Reading Completion and Expects Headline Results First Half of May 2024 | Pressreleaser | Ladda ner | Visa Stäng |
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2024-04-10 | 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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2024-04-08 | 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 |
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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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2024-03-27 | Ascelia Pharma | Kallelse till årsstämma i 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 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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2024-02-09 | 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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2024-02-04 | Ascelia Pharma | Ascelia Pharma Secures Financing of up to SEK 35 Million | Pressreleaser | 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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2024-01-24 | 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 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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2023-12-07 | 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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2023-12-06 | 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 | Kommuniké från extra bolagsstämma den 13 november 2023 i 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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2023-11-09 | 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 | 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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2023-11-08 | 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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2023-10-19 | Ascelia Pharma | KALLELSE TILL EXTRA BOLAGSSTÄMMA I ASCELIA PHARMA AB | Pressreleaser | 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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2023-10-04 | Ascelia Pharma | Ascelia Pharma får översiktsartikel om Orviglance accepterad för publicering i Investigative Radiology | Pressreleaser | Ladda ner | Visa Stäng |
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2023-10-04 | Ascelia Pharma | Ascelia Pharma Gets Acceptance for Publication of Orviglance Review Article in Investigative Radiology | Pressreleaser | Ladda ner | Visa Stäng |
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2023-09-18 | 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 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 | 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 | 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 | 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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2023-06-16 | 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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2023-05-15 | 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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