Ascelia Pharma Nears Submission of Orviglance NDA to FDA

Ascelia Pharma AB ( (SE:ACE) ) has provided an announcement.

Ascelia Pharma has announced an update on the submission timeline for its New Drug Application (NDA) for Orviglance to the US FDA. The NDA file is nearly complete, with the final electronic configuration expected to be finished in two to three weeks, after which the submission will occur. Orviglance is an oral contrast agent for MR-imaging, designed to improve the detection of liver lesions in patients with reduced kidney function, and has received Orphan Drug Designation from the FDA. This development marks a significant step for Ascelia Pharma in addressing the needs of patients at risk from current gadolinium-based agents, potentially enhancing its market position in the orphan oncology sector.

More about Ascelia Pharma AB

Ascelia Pharma is a biotech company specializing in orphan oncology treatments, developing and commercializing novel drugs to address unmet medical needs. The company, headquartered in Malmö, Sweden, is listed on Nasdaq Stockholm and has two drug candidates, Orviglance and Oncoral, in clinical development.

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