AnaptysBio shares were 11% higher after GSK received U.S. Food and Drug Administration approval for a treatment indication using a drug it licenses from AnaptysBio.
The FDA on Monday approved Jemperli plus carboplatin and paclitaxel, or chemotherapy, for the treatment of adult patients with mismatch repair deficient/microsatellite instability-high primary advanced or recurrent endometrial cancer.
AnaptysBio shares hit their 52-week low of $16.66 on Thursday, and are down 9% in the past 12 months.
The supplemental Biologics License Application supporting this new indication received Priority Review and was approved ahead of the Sept. 23 Prescription Drug User Fee Act action date.
The dual-primary endpoints in Part 1 of the trial are investigator-assessed progression-free survival and overall survival.
Jemperli was discovered by AnaptysBio and licensed to Tesaro, now a part of the GSK group of companies, under a collaboration and exclusive license agreement signed in March 2014. GSK is responsible for the ongoing development and commercialization of Jemperli. AnaptysBio is entitled to receive milestones and tiered royalties of 8% for net sales of Jemperli below $1 billion and 12% up to 25% of sales above $1 billion.
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