Day One Biopharmaceuticals – OJEMDA™: Enabling Brand Readiness for a Breakthrough Pediatric Brain Tumor Therapy

Day One Biopharmaceuticals partnered with Brandsymbol’s Regulatory division to support the regulatory pathway for OJEMDA™ (tovorafenib), a targeted therapy for pediatric low-grade glioma (pLGG).

Brandsymbol conducted trademark pre-screening, regulatory pre-screening, global linguistics evaluation, and brand name safety testing to ensure the name met strict regulatory and patient-safety standards across global markets.

In April 2024, the U.S. FDA approved OJEMDA™ as a once-weekly oral therapy for pediatric patients with low-grade glioma harboring specific genetic alterations. The European Medicines Agency’s CHMP has also issued a positive opinion recommending approval for patients six months and older, marking another milestone toward expanded access.

Through comprehensive naming risk mitigation and simulated prescribing evaluations, Brandsymbol helped position OJEMDA™ for successful regulatory review while supporting safe prescribing and dispensing practices.

Day One Biopharmaceuticals – OJEMDA™: Supporting the regulatory pathway for a targeted therapy in pediatric low-grade glioma

Learn more about Day One Biopharmaceuticals and the OJEMDA™ approval