NUVECTIS PHARMA INC

Nuvectis Pharma used the H.C. Wainwright conference to highlight its expanded pipeline and a cash position strengthened to around USD 120 million after a USD 150 million financing, which is expected to fund operations into the first half of 2029. Lead program NXP100 is approved in China for treatment‑naive PNH patients; a second approval and additional data on IgAN and lupus are expected by end‑2024 and March/April 2025, respectively. For the US, the company plans a pre‑IND meeting, a PK study in 2024 and two parallel registration studies aiming for a possible launch in 2029–2030. NXP200, a BRAF inhibitor for oncology, is expected to deliver preliminary data by the end of 2024. » Mere på de.investing.com

Nuvectis is focusing its strategy on NXP100, a once‑daily oral factor B inhibitor for PNH, positioning the drug as a direct rival to Novartis' FABHALTA. The company expects a pre‑IND meeting with the FDA in about a month and plans possible Phase‑III trials in the US in 2027 if the agency requires two pivotal studies; an NDA could be submitted as planned by the first half of 2029. Nuvectis holds roughly $130 million in cash—enough, management says, to fund the planned programs through mid‑2029—and sees additional opportunities in myasthenia gravis, IgA nephropathy and ophthalmology. The oncology programs NXP200 and NXP900 are secondary; Nuvectis emphasizes the once‑daily dosing regimen and existing Chinese approval and study data as competitive advantages. » Mere på de.investing.com

China's drug regulator has approved Ciprocopan, a once-daily orally administered complement factor B inhibitor from Nuvectis, for the treatment of treatment‑naïve PNH patients. The approval is based on a phase‑3 trial in which Ciprocopan met all primary and secondary endpoints versus eculizumab: 59.5% of Ciprocopan patients achieved Hb ≥12 g/dl versus 8.3% with eculizumab, the mean hemoglobin increase was 5.0 g/dl versus 2.2 g/dl, and 94.6% remained transfusion‑free versus 69.4%. Haisco will be responsible for development and commercialization in China; Nuvectis holds exclusive rights outside Greater China, India and parts of Southeast Asia. A separate approval application for previously treated PNH patients is under review in China. » Mere på de.investing.com