AnaptysBio-Generated Antibody Scores Second FDA Approval For Solid Tumor Indication

AnaptysBio-Generated Antibody Scores Second FDA Approval For Solid Tumor Indication
  • The FDA has approved a second indication for GlaxoSmithKline plc's GSK Jemperli (dostarlimab-gxly).
  • The approval comes for adult patients with mismatch repair deficient (dMMR) recurrent or advanced solid tumors that have progressed on or following prior treatment and have no satisfactory alternative treatment options.
  • Jemperli was approved for dMMR endometrial cancer in the U.S. and Europe in April.
  • Related content: Benzinga's Full FDA Calendar.
  • Jemperli was generated by AnaptysBio Inc ANAB using its proprietary somatic hypermutation (SHM) antibody platform and subsequently developed by Tesaro Inc, now a part of GSK, under a collaboration agreement. 
  • Eight AnaptysBio-generated therapeutic antibodies have advanced into clinical development to date. 
  • AnaptysBio has earned a $20 million milestone payment due to the second FDA approval for Jemperli.
  • An additional $180 million is due upon other milestone achievements.
  • AnaptysBio will receive 8% to 25% sales-based royalty on Jemperli.
  • Price Action: ANAB shares closed 6.6% higher at $25.19 on Tuesday, and GSK stock is trading 0.21% lower at $42.20 during the premarket session on the last check Wednesday.

Posted In: BriefsSolid TumorBiotechNewsHealth CareSmall CapFDAGeneral