News about "myelofibrosis"

Karyopharm to Seek US FDA Accelerated Approval for Selinexor-Ruxolitinib Combination in Myelofibrosis

Karyopharm to Seek US FDA Accelerated Approval for Selinexor-Ruxolitinib Combination in Myelofibrosis

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

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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