Ascelia Pharma (One-pager): FDA review underway and runway extended through 2026
Read the latest Ascelia Pharma one-pager following the FDA’s acceptance of the Orviglance new drug application (NDA) for review and the confirmation of an FDA decision date by 3 July 2026. This marks the official start of the regulatory review period and provides a clear timeline toward a potential first approval for the first gadolinium-free liver MRI contrast agent for patients with severe kidney impairment.
Our updated one-pager assesses the investment case in Ascelia Pharma following the updated FDA timeline for approval, recent increased capital via a private placement, and Q3 2025 results. With a cash runway now extending into Q4 2026 and ongoing FDA review process, the company is intensifying partnering discussions, which can support the commercial launch following approval.
The updated one-pager also includes valuation perspectives via the updated market-implied PoS estimates. You can also catch up on the latest presentation of the Q3 2025 results with Ascelia Pharma Deputy CEO Julie Waras Brogren. Link: https://www.inderes.dk/videos/ascelia-pharma-presentation-of-interim-q3-2025-report
Disclaimer: HC Andersen Capital receives payment from Ascelia Pharma for a digitalIR/corporate visibility subscription agreement. / Philip Coombes 08:25 18/11/2025