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pp-135

Solution for injection

Dossier type
CTD
Dossier status
Under development
Country of origin
United States
GMP approvals
FDA
Comments
Indication: Anaemia associated with myelofibrosis; anaemia of chronic kidney disease (non-dialysis) Clinical stage: Phase 2 — MOUNTAINSIDE trial (MF anaemia) and renal anaemia study ongoing Modality: Biologic (anti-hemojuvelin monoclonal antibody) Mechanism / Target: Blocks hemojuvelin (HJV) — a BMP co-receptor — suppressing hepcidin production; allows increased iron absorption and erythropoiesis Route / form: Subcutaneous injection Differentiation: Novel HJV-targeting approach bypasses EPO/ESA resistance; addresses functional iron restriction; potential in anaemia of inflammation without erythropoiesis-stimulating agents
Manufacturer #39168

Clinical-stage company specialising in haematopoietic and porphyria diseases. Develops small molecules that modulate haem biosynthesis to treat rare blood disorders. Wholly owned pipeline with multiple Phase 3 assets in rare disease.
 

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