uniQure Faces Setback in Gene Therapy Approval

uniQure ( (QURE) ) has shared an announcement.

On December 4, 2025, uniQure announced a regulatory update on its investigational gene therapy, AMT-130, for Huntington’s disease. Following a pre-Biologics License Application meeting with the FDA on October 29, 2025, the agency indicated that data from Phase I/II studies are unlikely to support a BLA submission. uniQure plans to urgently request a follow-up meeting with the FDA in early 2026 to address this feedback and advance the therapy for patients.

The most recent analyst rating on (QURE) stock is a Hold with a $27.00 price target. To see the full list of analyst forecasts on uniQure stock, see the QURE Stock Forecast page.

Spark’s Take on QURE Stock

According to Spark, TipRanks’ AI Analyst, QURE is a Neutral.

uniQure’s overall stock score is primarily impacted by its financial challenges, including negative profitability and cash flow issues. While technical indicators suggest bearish momentum, the earnings call provided some optimism with promising pipeline developments. However, regulatory setbacks and valuation concerns weigh heavily on the stock’s attractiveness.

To see Spark’s full report on QURE stock, click here.

More about uniQure

uniQure N.V. is a leading gene therapy company focused on developing transformative therapies for patients with severe medical needs. The company has achieved significant milestones in genomic medicine, including the approval of a gene therapy for hemophilia B, and is advancing a pipeline of proprietary gene therapies targeting Huntington’s disease, refractory temporal lobe epilepsy, ALS, Fabry disease, and other severe conditions.

Average Trading Volume: 4,535,594

Technical Sentiment Signal: Buy

Current Market Cap: $1.56B

For detailed information about QURE stock, go to TipRanks’ Stock Analysis page.