- The FDA has approved Apellis Pharmaceuticals Inc's APLS Empaveli (pegcetacoplan) for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH).
- PNH is a rare blood disease that causes red blood cells to break apart because the surface of a person's blood cells is missing a protein that protects them from the body's immune system.
- The drug is approved for use in adults with PNH who are treatment naïve and patients switching from the C5 inhibitors Soliris (eculizumab) and Ultomiris (ravulizumab).
- The company says Empaveli is the first and only targeted C3 therapy for PNH.
- Price Action: APLS shares are up 10.7% at $49 during the premarket session on the last check Monday.
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