Xspray Pharma: FDA rejects Dasynoc filing, company plans SEK 90m rights issue

what happened

According to TradingView, Xspray Pharma has published its interim report for the third quarter of 2026. The company recorded no revenue in the period, so it still has no sales. The loss before tax narrowed to SEK 39.3m from SEK 47.3m a year earlier, and the loss per share was SEK 0.83. For the first nine months, the pre-tax loss reached SEK 114.5m.

In August, the US Food and Drug Administration (FDA) issued a complete response letter on the new drug application for Dasynoc. The letter cites previously flagged manufacturing issues at third-party maker NerPharMa and asks for more data from consecutive commercial-scale batches. The agency raised no concerns about clinical data, bioequivalence or stability. The company intends to resubmit the application in the fourth quarter of 2026.

In October, the FDA confirmed that the Dasynoc application can be resubmitted regardless of NerPharMa's cGMP status. On 5 November, the regulator began an unannounced follow-up inspection of the NerPharMa facility. The board has also decided on a rights issue of about SEK 90m with preferential rights for existing shareholders, which can be increased by up to SEK 72m. The loan maturity has been extended to 15 August 2028, and after a scheduled repayment the facility will shrink to SEK 50m.

why it matters

For shareholders, the main risks are twofold: a drawn-out regulatory process tied to the key manufacturing partner, and dilution from the share issue. With no revenue yet, funding through new shares and talks with the lender will determine how long the company can operate before its products are approved.

market impact

Xspray shares: the rights issue dilutes existing holders, while FDA delays push back the path to market.

• ▼Xspray Pharma shares pressure down — a rights issue with preferential rights dilutes existing shareholders' stakes

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