Apellis Stock Soars 16.8% on FDA Approval of EMPAVELI

On July 29, 2025, Apellis' stock surged by 16.8% in pre-market trading, marking a significant rise in investor confidence.

The U.S. Food and Drug Administration (FDA) has approved Apellis' EMPAVELI® (pegcetacoplan) as the first treatment for C3 glomerulopathy (C3G) or primary immune complex membranoproliferative glomerulonephritis (IC-MPGN) in patients aged 12 and older. This approval is a major milestone for Apellis, as it addresses a critical unmet medical need for patients suffering from these rare and severe kidney diseases.

The approval of EMPAVELI® is expected to have a positive impact on Apellis' financial performance, as it opens up a new revenue stream from the treatment of these rare diseases. The drug's efficacy in reducing proteinuria and stabilizing kidney function is likely to drive demand, further boosting the company's market position.

This approval also underscores Apellis' commitment to innovation and its leadership in the development of novel therapies for rare diseases. The company's focus on complement inhibition technology has positioned it at the forefront of medical advancements in this field, attracting the attention of investors and healthcare professionals alike.