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Ascelia Pharma AB ( (SE:ACE) ) has shared an update.
Ascelia Pharma AB has submitted a New Drug Application (NDA) for Orviglance to the FDA, marking a significant milestone in its development. The submission follows successful clinical trials demonstrating Orviglance’s efficacy and safety, particularly in improving liver lesion visualization in patients with impaired kidney function. The company has also strengthened its financial position with a SEK 30 million share issue and convertible conversion, extending its cash runway into Q4 2026, beyond the expected FDA approval date. This progress supports Ascelia Pharma’s market potential and ongoing partnership discussions for Orviglance’s commercialization.
More about Ascelia Pharma AB
Ascelia Pharma AB operates in the pharmaceutical industry, focusing on the development of drugs for patients with unmet medical needs, particularly those with severe kidney impairment. The company’s primary product, Orviglance, is a liver MRI contrast agent designed for patients at risk of Nephrogenic Systemic Fibrosis due to gadolinium-based agents.
Average Trading Volume: 1,500,628
Technical Sentiment Signal: Sell
Current Market Cap: SEK407.1M
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