By Colin Kellaher
Agenus Inc. on Thursday said the U.S. Food and Drug Administration granted priority review to its biologics license application for balstilimab for the treatment of recurrent or metastatic cervical cancer.
The Lexington, Mass., clinical-stage immuno-oncology company said the agency set a target action date of Dec. 16 for the application, which covers balstilimab in cervical cancer with disease progression on or after chemotherapy.
The FDA grants priority review to medicines that have the potential to provide significant improvements in the treatment of a serious disease, and the designation shortens the review period.
Agenus said cervical cancer claims the lives of more than 300,000 women around the world each year, adding that current therapies for recurrent or metastatic cervical cancer are limited to a small subset of patients with limited benefit.
Shares of Agenus, which closed Wednesday at $5, rose nearly 6% in premarket trading Thursday.
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(END) Dow Jones Newswires