Xoma earns $5M milestone upon FDA acceptance of Day One’s tovorafenib NDA

XOMA (XOMA) announced it has earned a $5 million milestone related to the U.S. Food and Drug Administration’s, FDA, acceptance of Day One Biopharmaceuticals’ (DAWN) New Drug Application, NDA, for tovorafenib as a monotherapy for relapsed or progressive pediatric low-grade glioma. The FDA has granted tovorafenib Priority Review and established a Prescription Drug User Fee Act, PDUFA, date of April 30, 2024. “Tovorafenib has the potential to address a key unmet need in children whose low-grade gliomas with BRAF alterations have relapsed or progressed,” stated Owen Hughes, Executive Chairman of XOMA. “A novel, targeted, orally available option has the opportunity to set a new standard-of-care in this patient population.”