uniQure Aligns with FDA for AMT-130 BLA Approval

uniQure ( (QURE) ) has shared an update.

On June 2, 2025, uniQure announced alignment with the FDA on key components necessary for a Biologics License Application (BLA) for AMT-130, a gene therapy for Huntington’s disease. This alignment supports an accelerated approval pathway, with a BLA submission planned for early 2026. The company is leveraging extensive clinical data and FDA guidance to pursue the first disease-modifying treatment for Huntington’s disease, reflecting a significant step forward in addressing this unmet medical need.

The most recent analyst rating on (QURE) stock is a Buy with a $20.00 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 stock score reflects significant financial and operational challenges, with volatile revenue and persistent losses weighing heavily. While technical analysis shows some stability, valuation metrics highlight risks. Positive developments in the clinical pipeline and financial management provide some optimism, but the stock remains a high-risk investment.

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

More about uniQure

uniQure is a leading gene therapy company focused on developing transformative therapies for patients with severe medical needs. The company has pioneered gene therapies for hemophilia B and is advancing treatments for Huntington’s disease, refractory temporal lobe epilepsy, ALS, Fabry disease, and other severe conditions.

Average Trading Volume: 1,771,875

Technical Sentiment Signal: Buy

Current Market Cap: $792.2M

For an in-depth examination of QURE stock, go to TipRanks’ Stock Analysis page.