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Ascelia Pharma (ACE) investor relations material
Ascelia Pharma ABGSC Investor Days summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.ABGSC Investor Days summary4 Dec, 2025
Strategic focus and company overview
Focused on developing and commercializing novel drugs for rare cancer conditions, with operations in Sweden and the US and a global outlook.
Main assets are Orviglance (diagnostic) and Oncoral (therapeutic), with a partner-led commercialization strategy due to limited internal infrastructure.
Listed on NASDAQ Stockholm.
Orviglance: clinical progress, market opportunity, and differentiation
Orviglance is a first-in-class oral manganese-based MRI contrast agent for liver imaging in patients with severe renal impairment, offering a gadolinium-free alternative.
Addresses an $800 million global market, with nearly half in the US; initial commercialization focus is the US.
NDA for Orviglance submitted September 2025, with FDA PDUFA decision expected by July 3, 2026; orphan drug designation granted.
Clinical program includes nine studies showing strong efficacy, safety, and superior lesion visualization, with mostly mild gastrointestinal side effects.
Orviglance is positioned as the only liver MRI agent for patients with severe renal impairment, avoiding gadolinium-related risks and gaining strong support from nephrologists and radiologists.
Commercialization and partnership strategy
Commercialization will be partner-led, targeting large hospitals and a well-defined patient population, with ongoing discussions with multiple potential partners.
Manufacturing is at commercial scale with ample capacity; orphan drug status supports regulatory and market positioning.
Plans for global commercialization and expansion beyond the US.
Active engagement with the medical community and key opinion leaders to build awareness and prepare for launch.
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Next Ascelia Pharma earnings date
Q4 20255 Feb, 2026
Next Ascelia Pharma earnings date
Q4 20255 Feb, 2026
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Ascelia Pharma is an oncology-focused orphan drug development company with a portfolio of over 17 development stage drug candidates in a variety of cancer indications. Ascelia Pharma is headquartered in Malmö, Sweden.
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