Day One Biopharmaceuticals Drug Tovorafenib Gets FDA Accelerated Approval

By Josh Beckerman

Day One Biopharmaceuticals' drug tovorafenib, or Ojemda, received accelerated approval from the U.S. Food and Drug Administration for patients with relapsed or refractory BRAF-altered pediatric low-grade glioma.

The agency said this represents the first approval of a systemic therapy for treatment of patients with pediatric LGG with BRAF rearrangements, including fusions. The FDA granted tovorafenib a priority review in October.

Day One Biopharmaceuticals shares rose 10%, to $16.90.

Write to Josh Beckerman at [e-mail]

(END) Dow Jones Newswires

04-23-24 1522ET