uniQure N.V. (QURE) Q1 2026 Earnings Call Transcript
uniQure (QURE) came out with a quarterly loss of $0.85 per share versus the Zacks Consensus Estimate of a loss of $0.88. This compares to a loss of $0.82 per share a year ago.
Vinay Prasad, an official for the Food and Drug Administration, is reportedly stepping down, which is welcome news for biotech companies.
uniQure stock plunges 32% in a week after the FDA says AMT-130 phase I/II Huntington's disease data are not sufficient as primary evidence for a potential marketing application.
The heavy selling pressure might have exhausted for uniQure (QURE) as it is technically in oversold territory now. In addition to this technical measure, strong agreement among Wall Street analysts in revising earnings estimates higher indicates that the stock is ripe for a trend reversal.
uniQure (QURE) came out with a quarterly loss of $0.56 per share versus the Zacks Consensus Estimate of a loss of $0.93. This compares to a loss of $1.5 per share a year ago.
uniQure faces a major setback as the FDA reversed its stance on using external controls for AMT-130's approval, delaying its BLA submission. QURE's pivotal Phase 1/2 trial showed 75% slowing in cUHDRS at 36 months, but regulatory uncertainty now overshadows these results. With $694M in cash, QURE can weather a prolonged regulatory process, but AMT-130's near-term value is materially diminished.
uniQure N.V. ( QURE ) Q3 2025 Earnings Call November 10, 2025 8:30 AM EST Company Participants Chiara Russo - Senior Director of Investor Relations Matthew Kapusta - CEO & Executive Director Walid Abi-Saab - Chief Medical Officer Kylie O'Keefe - Chief Customer & Strategy Officer Christian Klemt - CFO, Principal Financial Officer & GM of Amsterdam Site Conference Call Participants Joseph Schwartz - Leerink Partners LLC, Research Division Uy Ear - Mizuho Securities USA LLC, Research Division Lydia Erdman - Goldman Sachs Group, Inc., Research Division Joseph Thome - TD Cowen, Research Division Luca Issi - RBC Capital Markets, Research Division Yanan Zhu - Wells Fargo Securities, LLC, Research Division Paul Matteis - Stifel, Nicolaus & Company, Incorporated, Research Division Presentation Operator Good morning, and welcome to uniQure's Third Quarter 2025 Earnings Call.
Uniqure NV (NASDAQ: QURE) shares plummeted more than 58% in early trading on Monday after the gene therapy company revealed that it was told by the US Food and Drug Administration (FDA) the clinical data for its gene therapy for Huntington's disease is inadequate. Uniqure said the FDA no longer agrees that data from Phase I/II trials, when compared with external control datasets, would be sufficient to support a Biologics License Application (BLA).
The company believes the Food and Drug Administration may deal a setback to one of its investigational therapies.
uniQure (QURE) possesses the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.
UniQure announced groundbreaking results for AMT-130, its gene therapy targeting Huntington's disease, showing a statistically significant 75% reduction in disease progression in a pivotal Phase I/II trial. ((UniQure's Press Release, Sep 24, 2025)) This milestone marks the first therapy to meaningfully slow Huntington's progression and positions UniQure to unlock value across revenue growth, margin expansion, and valuation rerating.