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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.

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