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Ascelia Pharma Nears NDA Submission for Orviglance

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Ascelia Pharma Nears NDA Submission for Orviglance

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Ascelia Pharma AB ( (SE:ACE) ) has issued an update.

Ascelia Pharma AB is nearing the submission of its New Drug Application (NDA) for Orviglance to the FDA, expected by early September 2025. The completion of the clinical development phase, marked by positive Phase 3 results, reinforces the drug’s market potential. The company has secured additional financing and is in discussions with potential partners for commercialization, aiming to enhance diagnostic options for cancer patients with kidney issues.

More about Ascelia Pharma AB

Ascelia Pharma AB operates in the pharmaceutical industry, focusing on developing novel drugs for orphan oncology indications. Their primary product, Orviglance, is a magnetic resonance imaging (MRI) contrast agent designed to improve liver lesion visualization in patients with impaired kidney function. The company is actively working on regulatory submissions and exploring commercialization partnerships.

Average Trading Volume: 1,014,621

Technical Sentiment Signal: Buy

Current Market Cap: SEK538.9M

For detailed information about ACE stock, go to TipRanks’ Stock Analysis page.

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