- The FDA has accepted GSK plc's (NYSE: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.
© 2026 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
To add Benzinga News as your preferred source on Google, click here.
