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Ascelia Pharma AB ( (SE:ACE) ) has provided an announcement.
Ascelia Pharma AB has announced a positive outcome from its FDA meeting regarding the New Drug Application (NDA) submission for Orviglance, expected by mid-2025. The company’s successful completion of the Phase 3 SPARKLE study, which demonstrated significant efficacy and safety of Orviglance, positions it well for regulatory approval and potential market entry. The company is also exploring partnerships for commercialization to enhance access to this innovative imaging solution for cancer patients with kidney impairments. Financially, Ascelia Pharma has strengthened its position with SEK 43 million from the exercise of warrants, ensuring a cash runway beyond 2025.
More about Ascelia Pharma AB
Ascelia Pharma AB operates in the pharmaceutical industry, focusing on the development of novel drugs for patients with rare oncology-related conditions. The company’s primary product is Orviglance, a magnetic resonance imaging (MRI) contrast agent designed to improve liver lesion visualization, especially in patients with impaired kidney function. Ascelia Pharma aims to address the unmet needs in liver imaging without the risks associated with gadolinium-based agents.
Average Trading Volume: 770,289
Current Market Cap: SEK443.8M
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