AnaptysBio Says JEMPERLI Drug Gets FDA Approval : comparemel

AnaptysBio Says JEMPERLI Drug Gets FDA Approval


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Dow Jones
By Adriano Marchese
AnaptysBio Inc. said Thursday that the U.S. Food and Drug Administration approved GlaxoSmithKline PLC's biologics license application for JEMPERLI, a treatment for endometrial cancer.
The clinical-stage biotechnology company said JEMPERLI, also known as dostarlimab-gxly, was generated by AnaptysBio and developed by TESARO Inc.--now a part of GSK--under a collaboration agreement.
AnaptysBio received a $20 million milestone payment as part of the approval.
A Biologics License Application for JEMPERLI--a treatment for patients with mismatch repair deficient recurrent or advanced endometrial cancer--is needed to obtain permission for distribution across U.S. states.
"This event provides important validation for our proprietary SHM antibody discovery platform and provides significant potential future milestone and royalty revenue to support AnaptysBio's growth," President and Chief Executive Hamza Suria said.

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