uniQure N.V. (NASDAQ:QURE) on Monday reported upbeat results for the fourth quarter.
uniQure reported quarterly losses of 56 cents per share which beat the analyst consensus estimate of losses of 94 cents per share. The company reported quarterly sales of $5.568 million which beat the analyst consensus estimate of $5.204 million.
The company also announced that the FDA has advised against using Phase 1/2 study data as primary evidence for the marketing application of AMT-130, its investigational gene therapy for Huntington’s disease.
The FDA strongly recommended that uniQure conduct a prospective, randomized, double-blind, sham surgery-controlled study to proceed.
“In 2025, we presented compelling 36-month clinical data from AMT-130 that we believe meaningfully demonstrate its potential to become a first disease-modifying therapy for people …