Chimerix (CMRX) shares were up over 237% in recent trading Tuesday a day after the company said it plans to submit a new drug application with the US Food and Drug Administration seeking accelerated approval for dordaviprone.
The application covers approval for dordaviprone as a treatment for recurrent H3 K27M-mutant diffuse glioma, a rare and aggressive type of brain tumor that primarily affects children and young adults.
The company said it will request a priority review of the NDA and that a potential initial Prescription Drug User Fee Act action date for accelerated approval could come in Q3 2025.
Price: 2.92, Change: +2.06, Percent Change: +237.57
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