tiprankstipranks
Trending News
More News >
Advertisement
Advertisement

uniQure Faces FDA Setback on Huntington’s Therapy

Story Highlights
  • uniQure announced a regulatory update on AMT-130 for Huntington’s disease after a meeting with the FDA.
  • The FDA’s changed stance on AMT-130’s data adequacy creates uncertainty around the BLA submission timing.
  • Looking for the best stocks to buy? Follow the recommendations of top-performing analysts.
uniQure Faces FDA Setback on Huntington’s Therapy

Elevate Your Investing Strategy:

  • Take advantage of TipRanks Premium at 50% off! Unlock powerful investing tools, advanced data, and expert analyst insights to help you invest with confidence.

The latest update is out from uniQure ( (QURE) ).

On November 3, 2025, uniQure announced a regulatory update regarding its investigational gene therapy for Huntington’s disease, AMT-130, following a pre-Biologics License Application meeting with the FDA. The company revealed that the FDA no longer agrees that data from Phase I/II studies of AMT-130 in comparison to an external control may be adequate for a BLA submission, creating uncertainty around the timing of the submission. Despite this setback, uniQure is committed to working with the FDA and other regulatory bodies to find a path forward for AMT-130’s approval, emphasizing the therapy’s potential benefits for patients with Huntington’s disease.

The most recent analyst rating on (QURE) stock is a Hold with a $67.00 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 weak financial performance, characterized by declining revenues and negative profit margins. The technical analysis provides some positive signals, but potential overbought conditions warrant caution. Valuation metrics are unfavorable due to ongoing losses and lack of dividends. Despite promising clinical advancements, the financial instability remains a significant concern.

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 advancing transformative therapies for patients with severe medical needs. The company is known for its gene therapy treatments, including a historic approval for hemophilia B, and is developing a pipeline of therapies for conditions such as Huntington’s disease, refractory temporal lobe epilepsy, ALS, and Fabry disease.

Average Trading Volume: 3,245,497

Technical Sentiment Signal: Buy

Current Market Cap: $4.17B

See more insights into QURE stock on TipRanks’ Stock Analysis page.

Disclaimer & DisclosureReport an Issue

Looking for investment ideas? Subscribe to our Smart Investor newsletter for weekly expert stock picks!
Get real-time notifications on news & analysis, curated for your stock watchlist. Download the TipRanks app today! Get the App
1