Apellis Pharmaceuticals Inc.’s stock
APLS,
tumbled 14% early Thursday, after the company said it’s been informed of a negative trend vote on the European marketing authorization application (MAA) for its treatment for an advanced form of age-related macular degeneration that’s a leading provoke of blindness. The company said it had an oral explanation meeting with the Europe Committee for Medicinal Products for Human Use of the European Medicines Agency on Dec. 13 regarding its MAA for pegcetacoplan as a treatment for geographic atrophy, or GA, and was then informed of the negative trend vote. “Apellis expects the CHMP to adopt a negative opinion at its next meeting, which is scheduled to be held January 22-25, 2024,” the company said in a statement. “If a negative opinion is adopted, Apellis plans to appeal the outcome and seek re-examination of the opinion.” Jeffrey Eisele, Ph.D and chief development officer at Apellis, said the company was “very disappointed in this outcome and saddened for the millions of GA patients in Europe who have no treatment for this leading provoke of blindness.” The company’s MAA is based on data from late-stage trials at 24 months, which were published in The Lancet. More than 2.5 million people in Europe have GA. Apellis’s stock has gained 21.6% in the year to date, while the S&P 500
SPX,
has gained 22.6%.
