GSK's Rare Blood Cancer Candidate Goes Under FDA Review

  • The FDA has accepted GSK plc's GSK marketing application for momelotinib, a potential new medicine with a proposed differentiated mechanism of action for myelofibrosis patients with anemia. 
  • Myelofibrosis is a rare blood cancer.
  • The U.S. FDA has assigned a Prescription Drug User Fee Act action date of 16 June 2023.
  • The application is based on the results from crucial Phase III trials, including the pivotal MOMENTUM trial, which met all primary and key secondary endpoints.
  • The trial's primary efficacy endpoint was a reduction in symptom severity score of ≥50% over the 28 days immediately before the end of Week 24 compared to baseline. 
  • Key secondary endpoints included Transfusion Independence rate for ≥12 weeks immediately before the end of Week 24 with hemoglobin levels ≥ 8 g/dL and Splenic Response Rate based on splenic volume reduction of ≥35% at Week 24 from baseline.
  • Price Action: GSK shares are down 2.55% at $34.37 during the premarket session on the last check Wednesday.
Market News and Data brought to you by Benzinga APIs
Posted In: BiotechLarge CapNewsHealth CareFDAMoversTrading IdeasGeneralBriefs
Benzinga simplifies the market for smarter investing

Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.

Join Now: Free!