Apellis Pharmaceuticals Faces Regulatory Setback in European Approval Efforts

Shares of Apellis Pharmaceuticals experienced a significant drop of nearly 15% in premarket trading following the company's warning of a potential regulatory setback. Apellis, a biopharmaceutical company, has been striving to win European approval for its treatment of geographic atrophy, an eye disease.

The stock initially closed at $62.88 on Wednesday but fell to $54.01 in premarket trading.

Apellis recently received news of a negative trend vote from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP). The CHMP is currently reviewing Apellis' application seeking approval of intravitreal pegcetacoplan, specifically for the treatment of geographic atrophy secondary to age-related macular degeneration.

The company anticipates that the CHMP will adopt a negative opinion in its upcoming meeting, scheduled for late January. However, despite the expected outcome, Apellis plans to appeal and seek re-examination.

It is worth noting that the European Commission, responsible for final decisions on drug approvals, often follows the advice provided by the CHMP.

In the United States, Apellis' pegcetacoplan injection has gained approval under the name Syfovre for the treatment of geographic atrophy secondary to age-related macular degeneration. Although the drug's label in the U.S. was recently updated to include information about rare events of retinal vasculitis, it did not receive a black-box warning. This warning is considered the most stringent that the U.S. Food and Drug Administration can apply to a drug.