Ascelia Pharma is a Swedish biopharma company listed on the Nasdaq Stockholm main market since March 2019. The company is focused on the development of a novel non-gadolinium based MRI contrast agent for the detection of liver metastases in cancer patients with impaired kidney function. The product Orviglance has successfully completed clinical Ph 3 (SPARKLE) in 2024 and is now in preparations towards submission of a NDA to the US FDA by mid'25. The second pipeline candidate Oncoral (novel chemotherapy formulation for gastric cancer) completed Ph 1 successfully and is Ph 2-ready.
Ascelia's lead drug candidate Orviglance has passed clinical development. Remaining risks remain FDA approval (small risk) and failure of meeting commercial targets (greater risk). Ascelia will also need to find a licensing partner to successfully launch the product in the US and prolong the company's financial runway until sufficient revenue is generated from partner milestones and royalties to reach profitability.