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Senaste pressmeddelanden och rapporter för bevakat bolag.

Datum Källa Rubrik Typ Alternativ
2024-05-08 Penser Access by Carnegie Penser Access by Carnegie: Ascelia Pharma: Medvind i seglen Pressreleaser Visa Stäng
2024-05-07 Ascelia Pharma Välkommen till Ascelia Pharma uppdatering till investerare: Att föra Orviglance till patienterna Pressreleaser Ladda ner | Visa Stäng
2024-05-07 Ascelia Pharma Welcome to Ascelia Pharma Investor Update: Bringing Orviglance to Patients Pressreleaser Ladda ner | Visa Stäng
2024-05-06 Ascelia Pharma Kommuniké från årsstämma den 6 maj 2024 i Ascelia Pharma AB Pressreleaser Ladda ner | Visa Stäng
2024-05-06 Ascelia Pharma Bulletin from the Annual General Meeting in Ascelia Pharma AB on 6 May 2024 Pressreleaser Ladda ner | Visa Stäng
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
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
2024-04-18 Ascelia Pharma Ascelia Pharma Draws Down SEK 15 Million Second Tranche Under Existing Loan Facility Pressreleaser Ladda ner | Visa Stäng
2024-04-18 Ascelia Pharma Ascelia Pharma utnyttjar den andra tranchen om 15 MSEK under befintlig lånefacilitet Pressreleaser Ladda ner | Visa Stäng
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
Pressreleaser | 10 Apr 2024 | Ascelia Pharma

Ascelia Pharma Reports SPARKLE Image Reading Completion and Expects Headline Results First Half of May 2024

Ascelia Pharma AB (publ) (ticker: ACE), a biotech focused on improving the life of people living with rare cancer conditions, today announced that the SPARKLE image reading by the independent readers has been successfully completed as planned. Headline results for the pivotal SPARKLE Phase 3 study of the orphan diagnostic drug candidate Orviglance® are now expected during the first half of May 2024 .

As part of the ongoing Phase 3 study SPARKLE image re-evaluation, the independent readers have completed the reading of all images according to plan. The image reading phase has therefore now been successfully completed. The final steps of the re-evaluation include data quality control and statistical analysis conducted by third parties.
 
The re-evaluation is on track for Ascelia Pharma to receive and report headline results by the first half of May 2024, which is in the beginning of the previously guided period.
 
Ascelia Pharma successfully completed patient enrollment in the Phase 3 study for Orviglance in March 2023. In early August, it was discovered that high intra-reader variability in the study image scoring by the independent radiologists prevented evaluation of the efficacy data from SPARKLE. Due to this finding, a new evaluation of the images with new independent readers was decided and is now underway. The purpose of the re-evaluation of the SPARKLE images is to obtain a scientifically valid and reliable efficacy result from the SPARKLE study. A positive result would together with the other available data support a regulatory approval for Orviglance.
 
“I am very pleased that the image re-evaluation has progressed according to our timelines. The image reading phase is a critical part of the re-evaluation and is now behind us. We all look forward to executing on the opportunities ahead for Ascelia Pharma – starting with the announcement of headline results during the first half of May 2024”, says Magnus Corfitzen, CEO Ascelia Pharma.
 
Orviglance has been granted an Orphan Drug Designation by the US Food and Drug Administration (FDA) for liver imaging in patients with severely impaired kidney function. With Orviglance, these patients can gain access to effective liver imaging without gadolinium-related safety risks. The unmet need for these patients represents an addressable market potential of USD 800 million globally; almost half of which is in the US.
 
About the SPARKLE study
The global multi-center SPARKLE study aims to demonstrate that Orviglance improves the detection and visualization of focal liver lesions, including liver metastases and primary tumors, in patients with severe kidney impairment. It is the last of nine studies in the extensive clinical development program for Orviglance, which will enable Ascelia Pharma to complete a New Drug Application (NDA) submission to the FDA.
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
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
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
2024-03-27 Ascelia Pharma Notice of Annual General Meeting in Ascelia Pharma AB Pressreleaser Ladda ner | Visa Stäng
2024-03-27 Ascelia Pharma Kallelse till årsstämma i Ascelia Pharma AB Pressreleaser Ladda ner | Visa Stäng
2024-02-21 Penser Access by Carnegie Penser Access by Carnegie: Interview with Ascelia Pharma - Carnegie Investment Bank - Feb 21th 2024 Pressreleaser Visa Stäng
2024-02-12 Penser Access by Carnegie Penser Access by Carnegie: Ascelia Pharma - Finansiering på plats, avgörande data i maj Pressreleaser Visa Stäng
2024-02-12 Redeye Redeye: Ascelia Pharma Q4 2023 - On track with easing financial pressure Pressreleaser Ladda ner | Visa Stäng
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
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
2024-02-04 Ascelia Pharma Ascelia Pharma säkrar finansiering om upp till 35 MSEK Pressreleaser Ladda ner | Visa Stäng
2024-02-04 Ascelia Pharma Ascelia Pharma Secures Financing of up to SEK 35 Million Pressreleaser Ladda ner | Visa Stäng
2024-01-24 Ascelia Pharma Orviglance Review Article Published in Investigative Radiology Pressreleaser Ladda ner | Visa Stäng
2024-01-24 Ascelia Pharma Översiktsartikel om Orviglance publicerad i Investigative Radiology Pressreleaser Ladda ner | Visa Stäng
2024-01-24 Ascelia Pharma Nomination Committee Appointed for AGM 2024 in Ascelia Pharma AB Pressreleaser Ladda ner | Visa Stäng
2024-01-24 Ascelia Pharma Valberedning utsedd i Ascelia Pharma AB inför årsstämman 2024 Pressreleaser Ladda ner | Visa Stäng
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
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
2023-12-06 Finansinspektionen Finansinspektionen: Flaggningsmeddelande i Ascelia Pharma AB Pressreleaser Visa Stäng
2023-11-30 Ascelia Pharma Change in Number of Shares and Votes in Ascelia Pharma AB Pressreleaser Ladda ner | Visa Stäng
2023-11-30 Ascelia Pharma Ändring av antalet aktier och röster i Ascelia Pharma AB Pressreleaser Ladda ner | Visa Stäng
2023-11-13 Ascelia Pharma Kommuniké från extra bolagsstämma den 13 november 2023 i Ascelia Pharma AB Pressreleaser Ladda ner | Visa Stäng
2023-11-13 Ascelia Pharma Bulletin from the Extraordinary General Meeting in Ascelia Pharma AB on 13 November 2023 Pressreleaser Ladda ner | Visa Stäng
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
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
2023-11-09 Penser Access Penser Access: Blickarna mot maj - Ascelia Pharma Pressreleaser Visa Stäng
2023-11-09 Redeye Redeye: Ascelia Q3 update - On track for a SPARKLE result in May 2024 Pressreleaser Ladda ner | Visa Stäng
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
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
2023-10-19 Ascelia Pharma KALLELSE TILL EXTRA BOLAGSSTÄMMA I ASCELIA PHARMA AB Pressreleaser Ladda ner | Visa Stäng
2023-10-19 Ascelia Pharma NOTICE OF EXTRAORDINARY GENERAL MEETING IN ASCELIA PHARMA AB Pressreleaser Ladda ner | Visa Stäng
2023-10-04 Ascelia Pharma Ascelia Pharma Gets Acceptance for Publication of Orviglance Review Article in Investigative Radiology Pressreleaser Ladda ner | Visa Stäng
2023-10-04 Ascelia Pharma Ascelia Pharma får översiktsartikel om Orviglance accepterad för publicering i Investigative Radiology Pressreleaser Ladda ner | Visa Stäng
2023-09-18 Redeye Redeye: Ascelia Pharma - All attention on the top priority Pressreleaser Ladda ner | Visa Stäng
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
2023-09-13 Ascelia Pharma Ascelia Pharma når headline-resultat från SPARKLE-utläsningen i maj 2024 med nuvarande finansiering Pressreleaser Ladda ner | Visa Stäng
2023-08-31 Ascelia Pharma Ascelia Pharma gör omfattande neddragning av organisationen för att nå headline-resultat med SPARKLE Pressreleaser Ladda ner | Visa Stäng
2023-08-31 Ascelia Pharma Ascelia Pharma significantly reduces organization to reach SPARKLE headline results Pressreleaser Ladda ner | Visa Stäng
2023-08-21 Penser Access Penser Access: I väntan på nästa milstolpe - Ascelia Pharma Pressreleaser Visa Stäng
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
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
2023-08-09 Ascelia Pharma Ascelia Pharma ger förtydliganden kring intraläsarvariabilitet vid utläsningen av bilder i SPARKLE-studien Pressreleaser Ladda ner | Visa Stäng
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
2023-08-09 Penser Access Penser Access: Oväntat utfall - Ascelia Pharma Pressreleaser Visa Stäng
2023-08-09 Redeye Redeye: Ascelia Pharma - SPARKLE is blurred Pressreleaser Ladda ner | Visa Stäng
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
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
2023-06-20 Penser Access Penser Access: Sanningens ögonblick - Ascelia Pharma Pressreleaser Visa Stäng
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
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
2023-05-15 Redeye Redeye: Ascelia Pharma - SPARKLE is about to sparkle Pressreleaser Ladda ner | Visa Stäng
2023-05-12 Penser Access Penser Access: Nyckelhändelse stundar - Ascelia Pharma Pressreleaser Visa Stäng
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
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

Kommande händelser

16 May 2024 | Kvartalsrapport 2024-Q1
15 Aug 2024 | Kvartalsrapport 2024-Q2
7 Nov 2024 | Kvartalsrapport 2024-Q3
7 Feb 2025 | Bokslutskommuniké 2024