Ascelia Pharma (One-pager): Bridging the gap between phase III success and FDA approval
Orviglance, positioned as the first and only gadolinium-free liver MRI contrast agent for this patient group, has received Orphan Drug Designation. Constructive feedback from the FDA has confirmed the NDA filing remains on track for mid-2025. Scientific recognition is growing, with 2025 data accepted at ESGAR, ISPOR, and RSNA, underlining clinical relevance and engagement from radiologists, nephrologists, and oncologists.
The company has strengthened its financial position with SEK 43m gross proceeds from the April 2025 warrant exercise, extending its cash runway beyond the NDA filing and through year-end 2025, excluding potential milestone payments from partnerships. The investment case is anchored in regulatory approval and a partner-led launch, targeting a global addressable market of USD 800m (USD 500–600m in the US, EU, and Japan) with 4–5% annual growth. The strong SPARKLE study headline data showing high Orviglance efficacy, “comparable” to current gadolinium-based imaging agents, may enable additional upside from off-label use in patients with normal kidney function. Particularly, as Ascelia Pharma research indicates over 80% of clinicians would likely adopt Orviglance upon approval.
Disclaimer: HC Andersen Capital receives payment from Ascelia Pharma for a Digital IR subscription agreement. /Claus Thestrup 2:45 PM (updated 9:16 PM), 19-08-2025.