EGRX - Eagle Pharma's TREAKISYM RTD formulation OK'd in Japan; launch expected in January 2021

Eagle Pharmaceuticals' (EGRX) marketing partner, SymBio Pharmaceuticals has received regulatory approval for TREAKISYM ready-to-dilute ((RTD)) (250 ml) liquid formulation from the Pharmaceuticals and Medical Devices Agency ((PMDA)) in Japan.As a result, the company will receive a $5M milestone payment. Product launch is expected in January 2021.The approval covers all indications for which TREAKISYM is currently approved (low-grade non-Hodgkin’s lymphoma, mantle cell lymphoma, and chronic lymphocytic leukemia).Approval for the additional indication of r/r DLBCL is currently under review by the PMDA. In addition, SymBio is currently conducting a clinical safety trial for the ten-minute RI (50 ml) liquid formulation and will seek approval in H2 2022. Japan sales for current TREAKISYM product totaled $84.8M for year ended June 30, 2020.

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Eagle Pharma's TREAKISYM RTD formulation OK'd in Japan; launch expected in January 2021