SOPHIA Positions MacroGenics' Margetuximab For Role In HER2-Positive Breast Cancer
MacroGenics' BLA for full approval in the US is under way and the company already has established a manufacturing facility in preparation for a launch.
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The drug may see a muted launch given the competitive landscape and a broad label despite its efficacy advantage in F-allele patients.
Public Company Edition: Four more IPOs in the US bring the year's total to seven – all in February. Also, Agenus launched its digital security offering, MacroGenics leads recent follow-on offerings and four companies reveal new job cuts.
US FDA labeling details the differences in performance of neratinib in adjuvant breast cancer by subgroup, as well as results relative to the timing of Roche's Herceptin, but the drug's indication covers all.