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Prothena Announces Confirmatory Phase 3 AFFIRM-AL Study of Birtamimab in Mayo Stage IV Patients with AL Amyloidosis under SPA Agreement with FDA

Feb 01, 2021 - GlobeNewswire

Significant survival benefit observed in VITAL study for birtamimab-treated patients with AL amyloidosis at high risk for early mortality (Mayo Stage IV, HR=0.413, p=0.025, over 9 months) SPA agreement with FDA to enable registration of birtamimab at unprecedented p < 0.10 for primary endpoint of all-cause mortality in Mayo Stage IV patients with AL amyloidosis AFFIRM-AL study of birtamimab expected to initiate mid-2021 Investor conference call and webcast scheduled Feb. 2 at 8:00am ET, Prothena...