Press release

ASCELIA PHARMA ANNOUNCES ACCEPTANCE OF ORVIGLANCE DATA FOR ORAL PRESENTATION AT THE ANNUAL RADIOLOGY CONGRESS ESGAR 2026

Ascelia Pharma AB (publ) (ticker: ACE), a biotech focused on improving the life of people living with rare cancer conditions, today announced that an abstract with an evaluation of the detection of focal liver lesions with Orviglance contrast agent from two phase 2 studies has been accepted for oral presentation at the European Society of Gastrointestinal and Abdominal Radiology (ESGAR) Annual Meeting, taking place 9-12 June in Montpellier, France.

The abstract titled “Diagnostic Value of Manganese-Based Contrast Agent (ACE-MBCA) vs Unenhanced MRI in Liver Lesion Detection: Re-analysis of STAR Study Images from Two Phase II Clinical Trials”, demonstrated that Orviglance significantly improves the detection of focal liver lesions compared to unenhanced MRI. The findings underline the potential of Orviglance as a new contrast agent for liver MRI.

“We are excited that an abstract with Orviglance data has been selected for oral presentation at ESGAR, one of the leading global forums for innovation in gastrointestinal and abdominal imaging. This recognition highlights the growing scientific interest in manganese-based contrast agents”, says Andreas Norlin, CSO of Ascelia Pharma.

Presenting author: Dr. D. Geisel (Charité - Universitätsmedizin Berlin, Germany)
Timing of presentation: 9 June 2026, 10:00 - 10:30 CET

Ascelia Pharma has submitted the New Drug Application (NDA) for Orviglance to the US Food and Drug Administration (FDA) with expected approval date of 3 July 2026.

About us

Ascelia Pharma is a biotech company focused on orphan oncology treatments. We develop and commercialize novel drugs that address unmet medical needs and have a clear development and market pathway. The company has two drug candidates – Orviglance and Oncoral – in development. Ascelia Pharma has global headquarters in Malmö, Sweden, and is listed on Nasdaq Stockholm (ticker: ACE). For more information, please visit http://www.ascelia.com.

About Orviglance
Orviglance (manganese chloride tetrahydrate) is a novel oral contrast agent for MR-imaging developed to improve the detection and visualization of focal liver lesions (including liver metastases and primary tumors) in patients with reduced kidney function. These patients are at risk of serious side effects from the currently available class of gadolinium-based contrast agents. Orviglance, has been granted an Orphan Drug Designation by the US Food and Drug Administration (FDA). A clinical program of nine studies, including the pivotal global Phase 3 study SPARKLE, has successfully been completed with strong and consistent efficacy and safety results. The New Drug Application (NDA) has been submitted to the FDA.