Nuvectis reports Q3 2026 results, advances ciprocopan and NXP200 toward US filings
Nuvectis says FDA talks on ciprocopan for PNH are underway with an update expected by year-end, as it plans US IND filings for both lead oncology and complement assets.
Nuvectis Pharma reported third quarter 2026 results on November 4, 2026, describing a transformed pipeline following its in-licensing of ex-China rights to NXP100 and NXP200 from Haisco Pharmaceutical Group. The company's lead candidate, ciprocopan (NXP100), a once-daily oral Complement Factor B inhibitor, was approved in China in July 2026 for treating PNH patients who had not previously received complement inhibitors.1
Nuvectis said discussions with the FDA on a U.S. regulatory path for ciprocopan in PNH are ongoing, with an update expected before year-end.1 A second China marketing application for ciprocopan, covering PNH patients previously treated with anti-C5 therapy, is under review with approval expected in the first quarter of 2027, and the company also has an ongoing Phase 3 trial in IgAN and a Phase 2 study in lupus nephritis in China.1 A Phase 3 head-to-head China study of ciprocopan versus eculizumab (Soliris) in complement-inhibitor-naive PNH patients was presented at the European Hematology Association 2026 conference, which the company said showed a robust efficacy advantage for ciprocopan.1 Nuvectis plans to submit a U.S. IND for NXP100 by year-end.1
For NXP200, its BRAF inhibitor, expanded Phase 1b glioma data as of a May 4, 2026 cutoff were presented at the 2026 ESMO Congress, covering 27 efficacy-evaluable patients with recurrent or progressive BRAF V600 glioma, including 20 with high-grade and 7 with low-grade disease.1 The overall response rate was 40.0% in high-grade glioma, including three complete responses, and 42.9% in low-grade glioma, including one confirmed complete response.1 A U.S. IND submission for NXP200 is also expected by year-end.1
On finances, the company held $140.7 million in cash as of September 30, 2026, up from $31.6 million at the end of 2025.1 Nuvectis said this cash position extends its runway into the second half of 2029.1
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.