Shares of Chimerix have topped 52-week highs following news the biopharmaceutical company plans to submit Dordaviprone for accelerated approval to the Food and Drug Administration before the end of the year.
The company's shares, which closed Monday's regular session at 86.5 cents, surged 172.36% to $2.36 in overnight trading.
The stock hit a 52-week high of $1.30 on March 8.
Chimerix said it was seeking accelerated approval for Dordaviprone as a treatment for certain patients with diffuse glioma, a type of brain cancer.
The company said Dordaviprone has received rare pediatric disease designation for H3 K27M-mutant glioma, adding it intends to apply for a rare pediatric disease priority review voucher in the upcoming NDA submission.
Mike Andriole, chief executive, said Chimerix bolstered it commercial leadership team and will be ready for a U.S. launch as early as the third quarter of next year, pending application acceptance and priority review, if granted.
Comments