The trial enrolled about 340 patients with melanoma. Xbrane says the study is expected to generate the clinical and analytical data needed to support regulatory submissions; no timelines for results or filings were given.

Xdivane is co-developed with Xbrane’s partner Intas Pharmaceuticals, which under a global license agreement is responsible for clinical development and, through its commercial arm Accord Healthcare, global commercialization. Opdivo is approved in several cancers, including melanoma, non-small cell lung cancer and renal cell carcinoma. Opdivo is one of the world’s largest cancer biologics, with 2025 sales of about USD 10 billion, according to Bristol Myers Squibb’s reported revenues.

“This is an important achievement for the Xdivane program,” says CEO Martin Åmark.