Karyopharm Therapeutics plans to file an sNDA with the US FDA seeking accelerated approval for selinexor in combination with ruxolitinib for myelofibrosis. Supported by positive Phase 3 SENTRY trial results, the combination has the potential to become the first approved frontline combination therapy for the rare blood cancer.
Myelofibrosis | 03/08/2026 | By News Bureau | 166
US FDA Grants Orphan Drug Designation to CK0804 Treg Therapy of Cellenkos
The US FDA has granted Orphan Drug Designation to Cellenkos’ CK0804, a first-in-class CXCR4hi Treg therapy for myelofibrosis. The investigational therapy is designed to home to the bone marrow and spleen, where it modulates inflammation through in-vivo expansion and IL-10 secretion.
Myelofibrosis | 07/01/2026 | By News Bureau | 175
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