Chimerix (CMRX) said Tuesday the US Food and Drug Administration has accepted a new drug application seeking accelerated approval for dordaviprone to treat recurrent H3 K27M-mutant diffuse glioma.
The application has been granted priority review and assigned a target action date of Aug. 18, the company said, adding the FDA does not plan to hold an advisory committee meeting to discuss the application.
Chimerix shares were rising past 15% in recent trading.
Price: 5.01, Change: +0.63, Percent Change: +14.38
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