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FDA Accepts Ascelia Pharma’s Orviglance NDA for Review

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FDA Accepts Ascelia Pharma’s Orviglance NDA for Review

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

Ascelia Pharma announced that the FDA has accepted the New Drug Application for Orviglance, a novel oral contrast agent for liver MRI in patients with impaired kidney function, for review. This milestone is significant as it progresses Orviglance towards availability for patients, potentially impacting the company’s discussions with commercialization partners and addressing a global market need of USD 800 million annually.

More about Ascelia Pharma AB

Ascelia Pharma is a biotech company based in Malmö, Sweden, focused on developing and commercializing orphan oncology treatments. The company is listed on Nasdaq Stockholm and has two drug candidates, Orviglance and Oncoral, in development. Ascelia Pharma aims to address unmet medical needs with a clear development and market pathway.

Average Trading Volume: 1,562,179

Technical Sentiment Signal: Sell

Current Market Cap: SEK362.7M

For a thorough assessment of ACE stock, go to TipRanks’ Stock Analysis page.

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