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.
Nordea leverer et stærkt halvårsregnskab og slår konsensus på stribe, Gubra henter en milepæl på 75 mio. fra Boehringer, Gabriel sælger FurnMaster fra, og North Media rammes af cyberangreb, få det hele i dagens Morgenbørs.
Markedet handler blandet her til morgen, Europa er en smule under pres på stigende oliepriser modsvaret af ASML regnskab, mens AI-tech optur sender asien og US futures op fra morgenstunden. Herhjemme fokus på banker, Royal Unibrew
Ascelia Pharma, Efter at aktien er faldet markant siden offentliggørelsen af den fulde Complete Response Letter (CRL) fra FDA. På det nuværende niveau er markedet begyndt at prisfastsætte de mest negative scenarier, nemlig et helt nyt klinisk studie eller ingen farbar vej gennem FDA, selvom de mindre alvorlige scenarier fortsat er forenelige med både ordlyden i det fulde CRL-brev og selskabets egne kommentarer.
Following the FDA's Complete Response Letter for Orviglance and the subsequent publication of the redacted letter, we set out what the current share price implies, the scenarios we see into the Type A meeting, and our reading of the clinical issue at the centre of the case.
Europæiske futures peger nedad fra morgenstunden på kraftig stigende oliepris og at Trump har lagt drikkepenge oveni transport igennem Hormuz. Herhjemme fokus på Zealand, Alm. Brand, banker forud for US og DK regnskaber
The FDA's Complete Response Letter (CRL) for Orviglance (NDA 220544) is now publicly accessible in redacted form through the FDA's openFDA transparency database. The letter's specifics raise the odds of a more demanding path to approval than previously indicated.
* CRL questions SPARKLE endpoint analysis; re-read rejected *Ascelia disputes both points; expresses confidence * Type A meeting next; outcomes range widely The CRL's stated grounds In the CRL (Complete Response Letter), the FDA states that SPARKLE failed...
SP Group offentliggjorde fredag en trading update for Q2 2026, der viste større salg og indtjening end ventet, hvormed selskabet opjusterede sine forventninger til omsætningsvæksten for hele året. Ascelia Pharma kom søndag aften med en opfølgning på FDA's afslag, og vurderer at de kliniske bekymringer relaterer sig til billedaflæsningsprocessen i SPARKLE-studiet snarere end de underliggende data, et scenarie der peger på en metode- og fortolkningsudfordring fremfor behov for helt nyt studie. MPC Energy Solutions nåede milestone med sin 66,1 MWp store solcellepark San Patricio i Guatemala, som har gennemført testfasen og nået COD, hvormed salget af aktivet under Project Merlin forventes afsluttet inden udgangen af juli og efterfulgt af kapitaludlodning på op til EUR 1,70 pr. aktie. GomSpace's CEO gennemgik blandt andet markedsudvikling, produktionsskalering, kommercielle modeller og ordrepipeline i online investor-session fredag.
Ascelia Pharma provided a follow-up update yesterday, July 12, on the Complete Response Letter received on July 3. This is the first substantive detail the company has disclosed on the nature of the FDA's clinical concerns since the CRL, and it meaningfully narrows, though does not close, the range of scenarios we flagged in our July 3 note.
I dagens Morgenbørs ser vi ind i en flad til negativ åbning i Europa, hvor der fortsat er fokus på en sektorrotation mod mere cykliske og defensive aktier. Herhjemme er der blandt andet fokus på Novo Nordisk, Carlsberg og North Media.
* Additional clinical data and product documentation requested * Urgent FDA meeting to discuss next steps * Very low visibility: Valuation suspended until more clarity Additional clinical data and product documentation requested Ascelia Pharma announced...
Ascelia Pharma today received a Complete Response Letter (CRL) from the FDA. The FDA stated it cannot approve the application for Orviglance in its present form and has requested additional clinical data and product documentation. This alters the investment case materially, and feedback from the Type A meeting with the FDA is the main short-term catalyst
Udsigt til en positiv åbning i Europa efter jobmarkedsrapporten i går. Børserne i USA holder lukket op til Uafhængighedsdag. Fokus herhjemme på bl.a. Maersk, ISS, B&O, NORDEN m.fl.
