- The European Commission has approved Swedish Orphan Biovitrum AB BIOVF - Apellis Pharmaceuticals Inc's APLS Aspaveli (pegcetacoplan) for paroxysmal nocturnal hemoglobinuria (PNH).
- The approval covers anemic patients after treatment with a C5 inhibitor for at least three months.
- PNH is a rare blood disorder where uncontrolled complement activation leads to the destruction of oxygen-carrying red blood cells through intravascular hemolysis and extravascular hemolysis.
- The approval is based on the results from the head-to-head PEGASUS phase 3 study, which evaluated the efficacy and safety of Aspaveli compared to eculizumab at 16 weeks.
- Related Link: Raymond James Upgraded This Biopharma Stock And Sees 44% Upside.
- Price Action: APLS shares are down 1.22% at $42.11 during the market session on the last check Wednesday.
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