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
Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.