Apellis Pharmaceuticals Inc (NASDAQ:APLS) shares fell more than 22% after it said it expects European regulators to reject its therapeutic intravitreal pegcetacoplan for the eye disease geographic atrophy (GA), an advanced form of age-related macular degeneration that is a leading cause of blindness.
The stock was down 22.8% at US$48.51 in the late morning on Thursday.
Apellis said that, following a December meeting on its marketing authorization application for the drug, it expects the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) to adopt a “negative opinion” at its next meeting, scheduled for January 2024.
The company said that should this occur, it plans to appeal the outcome.
Its marketing authorization application is based on the results from two late-stage clinical trials which showed treatment with pegcetacoplan monthly or ever-other-month reduced GA lesion growth with increasing treatment effects over time and was shown to be safe.
“We are very disappointed in this outcome and saddened for the millions of GA patients in Europe who have no treatment for this leading cause of blindness,” Apellis chief development officer Jeffrey Eisele said in a statement.
“We firmly believe in the strength of the Phase 3 results, and we will continue working closely with the CHMP, the retina community, and patient advocacy groups with the goal of bringing pegcetacoplan to GA patients in Europe.”