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An update from Ascelia Pharma AB ( (SE:ACE) ) is now available.
Ascelia Pharma has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration for Orviglance, an oral contrast agent for liver MRI in patients with severe kidney impairment. This submission follows the successful completion of nine clinical studies showing positive efficacy and safety results. Orviglance has been granted Orphan Drug Designation by the FDA, addressing a critical need for safer imaging options for patients at risk of Nephrogenic Systemic Fibrosis due to gadolinium-based agents. The potential market for Orviglance is estimated at USD 800 million annually, marking a significant step for Ascelia Pharma in meeting unmet medical needs and expanding its market presence.
More about Ascelia Pharma AB
Ascelia Pharma is a biotech company specializing in orphan oncology treatments, focusing on developing and commercializing novel drugs that address unmet medical needs. The company is headquartered in Malmö, Sweden, and is listed on Nasdaq Stockholm. Its primary drug candidates include Orviglance and Oncoral, both in clinical development.
Average Trading Volume: 1,020,511
Technical Sentiment Signal: Buy
Current Market Cap: SEK578.4M
For a thorough assessment of ACE stock, go to TipRanks’ Stock Analysis page.