In a Phase III trial, 28 percent of newly diagnosed patients with H3 K27M-mutant diffuse glioma responded to treatment with dordaviprone.
The European Commission granted approval for von Hippel-Lindau-associated renal cell carcinoma, CNS hemangioblastomas, or pancreatic neuroendocrine tumors.
The firm is seeking accelerated approval for UX111 using reductions in levels of heparan sulfate in cerebrospinal fluid as a surrogate endpoint.
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