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Xspray Pharma’s XS003 NDA Accepted by FDA with PDUFA Date Set

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Xspray Pharma’s XS003 NDA Accepted by FDA with PDUFA Date Set

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The latest announcement is out from Xspray Pharma AB ( (SE:XSPRAY) ).

Xspray Pharma AB announced that the FDA has accepted its New Drug Application for XS003, an improved formulation of nilotinib for treating chronic myeloid leukemia, with a PDUFA date set for June 18, 2026. This development signifies a major milestone for the company, potentially enhancing its market position in the U.S. oncology sector, with expectations of improved patient adherence due to reduced food effect and manufacturing processes already familiar to the FDA.

More about Xspray Pharma AB

Xspray Pharma AB is a pharmaceutical company specializing in the development of improved versions of marketed protein kinase inhibitors (PKIs) using its patented HyNap™ technology platform. The company focuses on the oncology market, aiming to become a leader in enhanced PKIs for cancer treatment. Xspray Pharma’s lead drug candidate, Dasynoc®, is under FDA review, and the company is expanding its portfolio with other optimized drug versions.

Average Trading Volume: 168,307

Technical Sentiment Signal: Sell

Current Market Cap: SEK1.07B

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

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