From GlobeNewswire: 2024-05-06 16:30:00

Day One Biopharmaceuticals has launched OJEMDA following FDA approval for BRAF-altered Pediatric Low-Grade Glioma. The first prescriptions have been received in the U.S. In the first quarter of 2024, the company reported financial results and highlighted recent achievements. OJEMDA is the first FDA-approved therapy for pediatric patients with relapsed or refractory pLGG. The Phase 3 FIREFLY-2/LOGGIC trial is ongoing, with over 90 sites activated for patient enrollment.

The Phase 1b/2 substudy of the FIRELIGHT-1 trial is evaluating tovorafenib with the MEK inhibitor pimasertib. The Company also received a rare pediatric disease priority review voucher from the FDA. Financially, Day One had a cash position of $317.9 million as of March 31, 2024. Research and development expenses increased due to additional activities related to OJEMDA. General and administrative expenses also rose due to company growth and buildout.

Day One Biopharmaceuticals will present abstract #10036 at the ASCO Annual Meeting and is scheduled to participate in the Goldman Sachs Global Healthcare Conference and the International Symposium on Pediatric Neuro-Oncology. Tovorafenib is a Type II RAF kinase inhibitor indicated for the treatment of relapsed or refractory pediatric low-grade glioma. OJEMDA is under accelerated approval based on response rate and duration of response. There are ongoing trials for front-line treatment and in combination with pimasertib for different patient populations with MAPK pathway alterations.



Read more at GlobeNewswire:: Day One Reports First Quarter 2024 Financial Results and