XOMA Earns $5 Million Milestone Upon FDA Acceptance of Day One’s Tovorafenib NDA for Relapsed or Progressive Pediatric Low-Grade Glioma

EMERYVILLE, Calif., Oct. 31, 2023 (GLOBE NEWSWIRE) — XOMA Corporation (NASDAQ: XOMA), the biotech royalty aggregator, announced today it has earned a $5 million milestone related to the U.S. Food and Drug Administration’s (FDA) acceptance of Day One Biopharmaceuticals’ New Drug Application (NDA) for tovorafenib for the treatment of relapsed or progressive pediatric low-grade glioma (pLGG).

Day One Biopharmaceuticals is a clinical-stage biotechnology company focused on developing and commercializing innovative therapies for children and young adults with cancer. Tovorafenib is an oral BRAF inhibitor that has shown promising results in clinical trials for patients with pLGG, a type of brain tumor that primarily affects children.

The FDA has granted Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) target action date of April 30, 2024, for Day One’s tovorafenib NDA. This designation is given to drugs that have the potential to provide significant improvements in the treatment, diagnosis, or prevention of serious conditions.

How This Will Affect Me

As a parent of a child with pediatric low-grade glioma, the acceptance of Day One’s tovorafenib NDA by the FDA offers hope for a new treatment option that may improve the outcomes for my child. This milestone represents progress in the development of targeted therapies for pediatric cancers, giving families like mine access to potentially life-saving medications.

How This Will Affect the World

The FDA’s acceptance of Day One’s tovorafenib NDA highlights the importance of advancing research and development in pediatric oncology. The approval of new treatments for rare childhood cancers not only benefits patients and their families but also contributes to the broader effort to improve cancer care and outcomes worldwide. This milestone underscores the critical need for continued innovation and investment in pediatric cancer therapeutics.

Conclusion

The acceptance of Day One’s tovorafenib NDA by the FDA and the $5 million milestone earned by XOMA Corporation mark significant achievements in the field of pediatric oncology. This progress brings renewed hope to families affected by pediatric low-grade glioma and underscores the importance of advancing research and development efforts in childhood cancer therapy.