Xspray - Improved HyNap-Dasa Ready to File (Sponsored Research, TP SEK175, 11 pgs)
Yesterday, Xspray achieved bioequivalence (BE) with Sprycel for its improved & lower dose version of Sprycel. Xspray is preparing to file by December under the 505(b)(2) pathway as well as expecting readouts for the generic HyNap-Dasa formulation on BE (Q321) & stability studies (Q122). If those readouts are positive, we expect an ANDA submission early next year. We remind investors that Xspray’s novel technology should allow them to circumvent some patents to allow them to be the only generic on the market. Despite only including risk adjusted HyNap-Dasa and HyNap-Nilo in our valuation, we see 33% upside.For access to the full note and our initiation , please contact Naresh Chouhan ( )
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