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Ascelia Pharma (One-pager): FDA review underway and runway extended through 2026

Ascelia Pharma
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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

Ascelia Pharma is a Swedish biotech company with a focus on orphan oncology treatments. They develop and commercialize novel drugs that address unmet medical needs and have a clear development and market pathway. Currently, Ascelia pharma has two pipeline products, namely Orviglance and Oncoral. Orviglance is a novel contrast agent for MR-Imaging developed to improve the detecting and visualization of focal liver lesions (Including liver metastases – and primary tumors) in patients with reduced kidney function. Oncoral is a daily tablet with an established potent anti-tumor effect – even in difficult to treat cancers with the potential to offer better patient outcomes with improved safety following a daily tablet treatment compared to intravenous high-dose infusions at the hospital. Ascelia Pharma is listed on Nasdaq Small Cap Stockholm with ticker ACE.

Read more on company page

Forum discussions

It has been on my watchlist. The stock crashed a few years ago when two graders had interpreted the same MRI images differently at different...
2/20/2026, 3:16 PM
by Clark kent
1
Like many other companies in the biotech sector, Ascelia has experienced total capitulation in its share price. However, it should be noted ...
2/13/2026, 10:37 AM
by Hawkmountdiver
1
Let’s open a thread for this one too. Ascelia is a company from Sweden specializing in cancer diagnostics and treatment. Company page: Ascelia...
5/4/2022, 3:32 PM
by Yu Gong
11
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