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2024-05-16 | Ascelia Pharma | Quarterly Report Q1: Primary Endpoint Met with Strong Headline Results in Orviglance Phase 3 Study | Rapporter | Download | Show Close |
Rapporter |
Quarterly Report Q1: Primary Endpoint Met with Strong Headline Results in Orviglance Phase 3 StudyAscelia Pharma AB (publ) (ticker: ACE) today published its Interim Report Q1 for 2024 (January – March), which is now available on the company’s website though this link . KEY EVENTS IN Q1 2024
KEY EVENTS AFTER THE PERIOD
FINANCIAL SUMMARY Q1 (Jan-Mar) 2024
“On 2 May 2024, we announced positive headline results from our Phase 3 study with Orviglance. It was a day the entire team has been eagerly waiting for. The results were strong and showed that Orviglance significantly improved visualization of focal liver lesions, successfully meeting the primary endpoint in the pivotal Phase 3 study, SPARKLE with statistical significance for all three readers (<0.001). These strong results mark the completion of clinical development for Orviglance and reinforce our confidence in the regulatory and commercial path ahead for Orviglance. We 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. Submission of the New Drug Application (NDA) to the US Food and Drug Administration (FDA) to obtain regulatory approval is expected by mid-2025. We look very much forward to executing on the opportunities ahead for Ascelia Pharma in 2024 and beyond”, said Magnus Corfitzen, CEO at Ascelia Pharma. A presentation for analysts, investors and media will be held today 16 May at 10:00am CET. The event will be hosted by the company’s CEO Magnus Corfitzen, Deputy CEO Julie Waras Brogren, and CSO Andreas Norlin. The presentation will be held in English. The presentation can be followed live via this link . |
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2024-05-16 | Ascelia Pharma | Kvartalsrapport Q1: Primärt effektmått uppnått med starka headline-resultat i fas 3-studien med Orviglance | Rapporter | Download | Show Close |
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2024-05-08 | Penser Access by Carnegie | Penser Access by Carnegie: Ascelia Pharma: Medvind i seglen | Pressreleaser | Show Close |
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2024-05-07 | Ascelia Pharma | Welcome to Ascelia Pharma Investor Update: Bringing Orviglance to Patients | Pressreleaser | Download | Show Close |
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2024-05-07 | Ascelia Pharma | Välkommen till Ascelia Pharma uppdatering till investerare: Att föra Orviglance till patienterna | Pressreleaser | Download | Show Close |
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2024-05-06 | Ascelia Pharma | Bulletin from the Annual General Meeting in Ascelia Pharma AB on 6 May 2024 | Pressreleaser | Download | Show Close |
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2024-05-06 | Ascelia Pharma | Kommuniké från årsstämma den 6 maj 2024 i Ascelia Pharma AB | Pressreleaser | Download | Show Close |
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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 | Download | Show Close |
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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 | Download | Show Close |
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2024-04-18 | Ascelia Pharma | Ascelia Pharma Draws Down SEK 15 Million Second Tranche Under Existing Loan Facility | Pressreleaser | Download | Show Close |
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2024-04-18 | Ascelia Pharma | Ascelia Pharma utnyttjar den andra tranchen om 15 MSEK under befintlig lånefacilitet | Pressreleaser | Download | Show Close |
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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 | Download | Show Close |
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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 | Download | Show Close |
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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 | Download | Show Close |
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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 | Download | Show Close |
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2024-03-27 | Ascelia Pharma | Kallelse till årsstämma i Ascelia Pharma AB | Pressreleaser | Download | Show Close |
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2024-03-27 | Ascelia Pharma | Notice of Annual General Meeting in Ascelia Pharma AB | Pressreleaser | Download | Show Close |
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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 | Show Close |
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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 | Show Close |
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2024-02-12 | Redeye | Redeye: Ascelia Pharma Q4 2023 - On track with easing financial pressure | Pressreleaser | Download | Show Close |
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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 | Download | Show Close |
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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 | Download | Show Close |
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2024-02-04 | Ascelia Pharma | Ascelia Pharma Secures Financing of up to SEK 35 Million | Pressreleaser | Download | Show Close |
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2024-02-04 | Ascelia Pharma | Ascelia Pharma säkrar finansiering om upp till 35 MSEK | Pressreleaser | Download | Show Close |
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2024-01-24 | Ascelia Pharma | Översiktsartikel om Orviglance publicerad i Investigative Radiology | Pressreleaser | Download | Show Close |
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2024-01-24 | Ascelia Pharma | Orviglance Review Article Published in Investigative Radiology | Pressreleaser | Download | Show Close |
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2024-01-24 | Ascelia Pharma | Nomination Committee Appointed for AGM 2024 in Ascelia Pharma AB | Pressreleaser | Download | Show Close |
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2024-01-24 | Ascelia Pharma | Valberedning utsedd i Ascelia Pharma AB inför årsstämman 2024 | Pressreleaser | Download | Show Close |
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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 | Download | Show Close |
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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 | Download | Show Close |
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2023-12-06 | Finansinspektionen | Finansinspektionen: Flaggningsmeddelande i Ascelia Pharma AB | Pressreleaser | Show Close |
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2023-11-30 | Ascelia Pharma | Ändring av antalet aktier och röster i Ascelia Pharma AB | Pressreleaser | Download | Show Close |
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2023-11-30 | Ascelia Pharma | Change in Number of Shares and Votes in Ascelia Pharma AB | Pressreleaser | Download | Show Close |
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2023-11-13 | Ascelia Pharma | Kommuniké från extra bolagsstämma den 13 november 2023 i Ascelia Pharma AB | Pressreleaser | Download | Show Close |
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2023-11-13 | Ascelia Pharma | Bulletin from the Extraordinary General Meeting in Ascelia Pharma AB on 13 November 2023 | Pressreleaser | Download | Show Close |
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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 | Download | Show Close |
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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 | Download | Show Close |
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2023-11-09 | Penser Access | Penser Access: Blickarna mot maj - Ascelia Pharma | Pressreleaser | Show Close |
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2023-11-09 | Redeye | Redeye: Ascelia Q3 update - On track for a SPARKLE result in May 2024 | Pressreleaser | Download | Show Close |
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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 | Download | Show Close |
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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 | Download | Show Close |
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2023-10-19 | Ascelia Pharma | NOTICE OF EXTRAORDINARY GENERAL MEETING IN ASCELIA PHARMA AB | Pressreleaser | Download | Show Close |
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2023-10-19 | Ascelia Pharma | KALLELSE TILL EXTRA BOLAGSSTÄMMA I ASCELIA PHARMA AB | Pressreleaser | Download | Show Close |
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2023-10-04 | Ascelia Pharma | Ascelia Pharma får översiktsartikel om Orviglance accepterad för publicering i Investigative Radiology | Pressreleaser | Download | Show Close |
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2023-10-04 | Ascelia Pharma | Ascelia Pharma Gets Acceptance for Publication of Orviglance Review Article in Investigative Radiology | Pressreleaser | Download | Show Close |
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2023-09-18 | Redeye | Redeye: Ascelia Pharma - All attention on the top priority | Pressreleaser | Download | Show Close |
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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 | Download | Show Close |
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2023-09-13 | Ascelia Pharma | Ascelia Pharma når headline-resultat från SPARKLE-utläsningen i maj 2024 med nuvarande finansiering | Pressreleaser | Download | Show Close |
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2023-08-31 | Ascelia Pharma | Ascelia Pharma significantly reduces organization to reach SPARKLE headline results | Pressreleaser | Download | Show Close |
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2023-08-31 | Ascelia Pharma | Ascelia Pharma gör omfattande neddragning av organisationen för att nå headline-resultat med SPARKLE | Pressreleaser | Download | Show Close |
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2023-08-21 | Penser Access | Penser Access: I väntan på nästa milstolpe - Ascelia Pharma | Pressreleaser | Show Close |
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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 | Download | Show Close |
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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 | Download | Show Close |
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2023-08-09 | Ascelia Pharma | Ascelia Pharma ger förtydliganden kring intraläsarvariabilitet vid utläsningen av bilder i SPARKLE-studien | Pressreleaser | Download | Show Close |
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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 | Download | Show Close |
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2023-08-09 | Penser Access | Penser Access: Oväntat utfall - Ascelia Pharma | Pressreleaser | Show Close |
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2023-08-09 | Redeye | Redeye: Ascelia Pharma - SPARKLE is blurred | Pressreleaser | Download | Show Close |
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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 | Download | Show Close |
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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 | Download | Show Close |
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2023-06-20 | Penser Access | Penser Access: Sanningens ögonblick - Ascelia Pharma | Pressreleaser | Show Close |
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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 | Download | Show Close |
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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 | Download | Show Close |
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