Apellis Pharmaceuticals (NASDAQ:APLS) jumps 49% premarket on robust volume in reaction to positive results from a Phase 3 clinical trial, PEGASUS, evaluating pegcetacoplan (APL-2) in adults with paroxysmal nocturnal hemoglobinuria (PNH).
The study met the primary endpoint demonstrating superiority over Alexion Pharmaceuticals’ (NASDAQ:ALXN) Soliris (eculizumab) as measured by the change from baseline in hemoglobin level at week 16. Specifically, patients receiving pegcetacoplan showed an adjusted mean hemoglobin increase of 3.8 g/dL compared to a mean decrease of -1.5 g/dL in the eculizumab arm (p<0.0001).
Pegcetacoplan showed non-inferiority to eculizumab on transfusion avoidance and absolute reticulocyte count.
All patients who completed the randomization period in both groups (n=77/80) entered the 32-week open-label pegcetacoplan treatment period.
Detailed results will be submitted for presentation at a future medical conference.
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