FDA Grants Orphan Drug Designation to CK0804 in Myelofibrosis | Targeted Oncology - Immunotherapy, Biomarkers, and Cancer Pathways

New Treg Therapy Earns FDA Orphan Drug Designation in Myelofibrosis

Prior data from the 2025 ASH meeting showed that CK0804 may complement JAK inhibition among patients with myelofibrosis.

FDA Grants Orphan Drug Designation to CK0804 in Myelofibrosis | Targeted Oncology - Immunotherapy, Biomarkers, and Cancer Pathways

CK0804, a novel Treg therapy, gains FDA orphan drug status for myelofibrosis, promising new hope for patients with limited treatment options.

Cellenkos gains FDA orphan drug status for CK0804 to treat myelofibrosis

The condition has an estimated prevalence of 25,000 patients in the US and an annual incidence of one to three new cases per 100,000 people. CK0804 is an The post Cellenkos gains FDA orphan drug status for CK0804 to treat myelofibrosis appeared first on Pharmaceutical Business review.