Apellis Pharmaceuticals APLS announced that the FDA has accepted its supplemental new drug application (sNDA) seeking the label expansion of Empaveli (pegcetacoplan) for two rare and severe kidney ...

Apellis Pharmaceuticals APLS announced that the FDA has accepted its supplemental new drug application (sNDA) seeking the label expansion of Empaveli (pegcetacoplan) for two rare and severe ...

Empaveli (pegcetacoplan) is a prescription drug that treats paroxysmal nocturnal hemoglobinuria (PNH) by preventing the destruction of red blood cells in your blood vessels, liver, and spleen.

The label comes with a few important restrictions/caveats that leave room for Apellis’s (APLS) Empaveli to differentiate itself. The firm highlights that Fabhalta is indicated for adults with ...

Apellis Pharmaceuticals APLS announced that the FDA has accepted its supplemental new drug application (sNDA) seeking the label expansion of Empaveli (pegcetacoplan) for two rare and severe kidney ...

The Prescription Drug User Fee Act (PDUFA) target action date is July 28, 2025. “EMPAVELI demonstrated clinically meaningful benefits across all three key markers of disease – unprecedented ...

Apellis' Empaveli receives FDA Priority Review for rare kidney diseases C3G and IC-MPGN. Phase 3 data show strong efficacy in ...

The Prescription Drug User Fee Act, PDUFA, target action date is July 28, 2025. “EMPAVELI demonstrated clinically meaningful benefits across all three key markers of disease – unprecedented ...

WALTHAM, Mass. - The U.S. Food and Drug Administration (FDA) has accepted Apellis Pharmaceuticals, Inc.’s (NASDAQ: APLS) supplemental New Drug Application (sNDA) and granted Priority Review ...

Apellis is also angling its Sobi-partnered C3 inhibitor Empaveli (pegcetacoplan) for a C3G nod. And by analysts’ observations, Apellis has better efficacy data. In the phase 3 Valiant trial ...