The public release of Xspray’s CRL on openFDA yesterday triggered a double-digit intraday decline in the stock, which ultimately closed down 9%. While the market was largely aware of the issues related to the company’s contract manufacturer in Italy, sentiment appears to have deteriorated following the CRL’s wording around medication error risk and the associated requirement for comprehension studies and modified labeling. However, in our discussion with the CEO yesterday he reiterated Xspray's expectation of resubmitting Dasynoc NDA in Q1 2026 and preparations for the launch of both Dasynoc and XS003 in H2 2026, offering a constrasting view compared to the market's interpretation, of the masked document.
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