Apellis Pharma (APLS) stock experienced a sharp pre-market decline following news that it anticipates a negative opinion from a European regulator on Pegcetacoplan at its upcoming meeting.
The stock fell 14.1% in early trade.
After receiving a negative trend vote during an oral explanation meeting on December 13, Apellis expects the Committee for Medicinal Products for Human Use (CHMP) to adopt a negative opinion during its meeting scheduled for January 22-25, 2024.
In the event of a negative opinion, Apellis plans to appeal the outcome and seek re-examination of the opinion, the company said.
“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,” said Jeffrey Eisele, Ph.D., chief development officer, Apellis.
“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.”