# Xspray Pharma Reports SEK 114.5 Million Nine-Month Loss and Plans Q4 2026 NDA Resubmission

> Xspray Pharma posted a SEK 114.5 million nine-month loss and zero net sales, while planning to resubmit both NDAs in Q4 2026 and raising about SEK 90 million.

- Published: 2026-11-06T07:22:13+00:00
- Section: Earnings & Results
- Author: News Desk
- URL: https://newsforagent.com/news/2026-11-06/xspray-pharma-q3-2026-loss-resubmission
- Source: [TradingView](https://www.tradingview.com/news/modular_finance:5f4fbf58b2811:0-xspray-pharma-publishes-interim-report-for-the-third-quarter-2026/)

## Key takeaways

- Xspray Pharma reported net sales of SEK 0 and a net loss of SEK 114.5 million for January to September 2026.
- The FDA issued a Complete Response Letter for Dasynoc in August 2026 over GMP observations at NerPharMa and a request for additional commercial-scale batch data.
- Xspray Pharma plans to resubmit both NDAs in Q4 2026 and announced a rights issue of approximately SEK 90 million.

Xspray Pharma reported net sales of SEK 0 and a net loss of SEK 114.5 million for January to September 2026, and said it plans to resubmit both of its new drug applications in the fourth quarter of 2026. The Swedish oncology developer published the figures in its third-quarter interim report, [TradingView](https://www.tradingview.com/news/modular_finance:5f4fbf58b2811:0-xspray-pharma-publishes-interim-report-for-the-third-quarter-2026/) reported. Xspray Pharma uses its HyNap technology platform to develop improved formulations of marketed protein kinase inhibitors, with Dasynoc and Nilopki as its lead candidates in chronic myeloid leukemia.

## Dasynoc Letter and the NerPharMa Batch Work

For July to September 2026, Xspray Pharma reported earnings before tax of SEK -39,323 thousand, compared with SEK -47,332 thousand a year earlier, and earnings per share before dilution of SEK -0.83, against SEK -1.25. Cash flow from operating activities was SEK -33,374 thousand for the quarter and SEK -100,996 thousand for the nine months.

In August, the U.S. Food and Drug Administration issued a Complete Response Letter for the Dasynoc NDA. Xspray Pharma said the letter concerns previously communicated GMP observations at third-party manufacturer [NerPharMa](https://akta.pro/company-profiles/000aim2/nerpharma) and a request for additional commercial-scale consecutive batch data following implemented corrective actions. The FDA raised no questions on clinical data, bioequivalence or stability, and the medication-error risk from earlier review cycles has been resolved, according to the company.

In October, Xspray Pharma said the FDA confirmed the Dasynoc NDA can be resubmitted independently of NerPharMa's cGMP status, as previously confirmed for Nilopki. Manufacturing of the additional commercial batches has commenced, and final regulatory clearance of the facility is still required before approval. On November 5, the company was informed that the FDA had begun an unannounced follow-up inspection at NerPharMa's facility.

Xspray Pharma also announced a board decision to carry out a rights issue of approximately SEK 90 million with preferential rights for existing owners, increaseable by up to SEK 72 million through an over-allotment option. The lender agreement extends the existing loan's maturity to August 15, 2028 and reduces the facility to SEK 50 million after a contractual repayment.

## Earlier FDA Setbacks and Financing Moves

On August 19, 2026, MarketScreener reported that the FDA issued a Complete Response Letter to Xspray Pharma for Dasynoc, and that the company planned to resubmit its application in 2026. On October 2, 2026, MarketScreener reported that Xspray Pharma still planned to resubmit the Dasynoc and Nilopki NDAs to the FDA in the fourth quarter of 2026.

## What Comes After the Q4 Resubmission

Xspray Pharma said it intends to resubmit both applications during the fourth quarter of 2026, after which a new PDUFA date will be issued. The company said its plan is to be in a position to launch both Dasynoc and Nilopki in the quarter immediately following approval, subject to successful resubmission, FDA review and resolution of the remaining manufacturing facility matters.

## Companies in this story

- Xspray Pharma · website: https://xspraypharma.com
- [NerPharMa company profile](https://akta.pro/company-profiles/000aim2/nerpharma) · website: https://www.nerpharma.com

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