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 living with Huntington’s disease,” said Matt Kapusta, chief executive officer at uniQure. “While we have not reached alignment with the FDA on an approval pathway, we remain confident in the strength and durability reflected in our dataset. We are committed to engaging with the FDA to define a clear and efficient path to bring this potentially transformative therapy to Huntington’s disease patients in urgent need for treatments.”
uniQure shares dipped 13.3% to trade at $9.12 on Tuesday.
These analysts made changes to their price targets on uniQure following earnings announcement.
- Mizuho analyst Uy Ear downgraded uniQure from Outperform to Neutral and lowered the price target from $33 to $12.
- Chardan Capital analyst Daniil Gataulin maintained the stock with a Buy and lowered the price target from $53 to $16.
Considering buying QURE stock? Here’s what analysts think:
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