Xspray: HyNap-Dasa study set to start2018-08-02 18:27
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Xspray's Italian manufacturing partner NerPharMa has delivered the HyNap-Dasa clinical material required for the upcoming study. Xspray are set to deliver results in Q3, according to plan.
The upcoming study is a so-called pilot study, a trial where Xspray will test two formulations of HyNap-Dasa in healthy volunteers with an aim to confirm that a formulation is bioequivalent to the reference listed drug Sprycel (dasatinib). Results can be presented during Q3, and if positive, HyNap-Dasa will then be moved into a pivotal trial which Xspray believes could start in 2019.
Qualitative manufacturing of the product is critical for approval and a successful drug launch. The technology transfer seems to have gone according to plan, and with NerPharMa producing according to GMP in a FDA-approved facility, Xspray is well set up for future studies and filings.
While the ANDA pathway is the main goal, Xspray can still keep their options open with HyNap-Dasa being developed for both the ANDA (generic) and 505(b)(2) (improved generics) pathways. We see a good case in Xspray going forward and believe that study data during 2018-2019 and the short time to market could attract significant investor interest. Our Base Case remains at SEK 120, with Bull and Bear Case at SEK 220 and SEK 35, respectively.
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