03:52 PM EDT, 08/06/2025 (MT Newswires) -- Jazz Pharmaceuticals ( JAZZ ) said Wednesday that the US Food and Drug Administration granted accelerated approval for Modeyso, or dordaviprone, for the treatment of patients 1 year of age and older with recurrent H3 K27M-mutant diffuse midline glioma, a type of brain tumor.

The FDA's decision was based on an integrated efficacy analysis of 50 patients with recurrent H3 K27M-mutant diffuse midline glioma from five open-label clinical studies, with an overall response rate of 22%, Jazz said.

Shares of the company fell 6.3% in late afternoon trading.

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