Xspray Pharma: XS003 NDA expected in H2 2024 – Redeye


Redeye views today’s press release from Xspray positively. The confirmation that XS003 has demonstrated bioavailability within the 80%-125% range to Tasigna at a lower dose is a positive development for the investment case, and further supports Xspray’s claim that its technology is applicable to a wide range of PKIs. The company anticipates submitting its NDA to the FDA in H2 2024 once all necessary studies, including food effect and PPI interaction studies, are finalized. Xspray will host a CMD tomorrow, where we anticipate gaining further insights into the matter. Following the CMD, we will provide a more detailed comment on its content and adjust our XS003 likelihood of approval for the announcement and potential news from the CMD. As a result, we also expect to slightly increase our fair value range.