The English text is an unofficial translation. In case of any discrepancies between the Swedish text and the English translation, the Swedish text shall prevail.
Ascelia Pharma AB (publ) (ticker: ACE) today published its Annual Report 2025, which is now available on the company’s website.
Magnus Corfitzen, CEO, Ascelia Pharma, says:
Following the Orviglance New Drug Application (NDA) submission in September 2025, we received the US Food and Drug Administration (FDA) Day 74 letter in November, which formally accepted our NDA for review, aiming for a decision by 3 July 2026 as the PDUFA date. This milestone underscores the quality and completeness of our submission and marks a critical step toward making Orviglance available to patients with severe kidney impairment who need a contrast enhanced liver MRI procedure. We look forward to continuing to work with the FDA throughout the review process.
The NDA submission is based on the successful completion of the development program, which includes nine clinical studies with consistent positive efficacy and safety results. In our Phase 3 study, SPARKLE, Orviglance significantly improved visualization of focal liver lesions in patients with impaired kidney function, meeting the primary endpoint with statistical significance for all three readers (<0.001).
We have a cash runway into Q4 2026, well beyond the expected FDA approval date of Orviglance. This follows a directed share
issue in September 2025, raising SEK 30 million before costs, which strengthened our balance sheet based on the inbound interest expressed by investors.
Our partnering process continues to progress, and multiple potential partners demonstrate strong strategic interest. With the regulatory timeline now firmly established, these dialogues have gained additional momentum and clarity, and we remain well positioned to secure a partnering agreement.