FDA starts inspection at Xspray’s drug manufacturer
Xspray Pharma says the US FDA has begun an inspection at NerPharMa, the contract manufacturer whose cGMP status must be cleared before the agency can approve the company’s cancer drugs Dasynoc and Nilopki. Xspray has also resolved on a rights issue of about SEK 90 million, which can be increased by about SEK 72 million through an over-allotment issue.
November 9, 2026
Xspray says it cannot yet assess the duration or outcome of the inspection. The FDA generally aims to notify a facility of its final classification within 90 days. The company still plans to resubmit the New Drug Applications for both products in the fourth quarter of 2026, which the FDA has confirmed can happen independently of NerPharMa’s status. In August, the FDA issued a Complete Response Letter for Dasynoc, citing GMP observations at NerPharMa and requesting additional commercial-scale batch data.
About 116% of the rights issue is covered by subscription undertakings and intentions from shareholders and new investors, including Flerie, the Fourth Swedish National Pension Fund and Unionen. The subscription price is SEK 9.50 per share, with subscription running from November 17 to December 1. Xspray expects the proceeds to cover its working capital needs until the anticipated approvals, or for about 12 months if launches are delayed.
Dasynoc and Nilopki are amorphous formulations of the kinase inhibitors dasatinib (Sprycel) and nilotinib (Tasigna), developed using Xspray’s HyNap technology.
“This financing strengthens our ability to advance the remaining regulatory activities and continue preparations for the anticipated regulatory approvals and planned commercial launches in 2027,” says Blake Leitch, CEO.
Source: Xspray Pharma press releases, 5–6 November 2026 — FDA inspection · rights issue · Q3 repor
Published: November 9, 2026
