Nuvectis’ NXP200 gains China breakthrough therapy designation for BRAF-mutant gliomas

Nuvectis Pharma, Inc. (NASDAQ: NVCT) announced it has received Breakthrough Therapy Designation from China’s Center for Drug Evaluation (CDE) for NXP200, an oral, brain-penetrant BRAF inhibitor. The designation targets patients with recurrent or progressive BRAF V600-mutant high-grade glioma—a form of primary central nervous system tumor—marking a key milestone in the drug’s development pathway. NXP200 is designed to block the BRAF pathway without triggering paradoxical activation, a common side effect seen in first-generation BRAF inhibitors. Clinical data suggest it shows activity in heavily pre-treated patients across multiple cancers, including non-small cell lung cancer, colorectal cancer, and papillary thyroid cancer.