QURE stock gains as uniQure moves closer to FDA review for Huntington’s gene therapy

Published on 09/05/2026 at 09:15 | Editorial responsibility: Rafael Müller, Editor-in-Chief AD HOC NEWS

QURE stock is trading firmly in the mid-40 dollar range as uniQure’s accelerated approval filing for its Huntington’s gene therapy and a bullish analyst consensus put the biotech back on the radar of gene therapy investors.

QURE, IL0011559904, Illustration mit AI erstellt.

QURE stock of Dutch gene therapy developer uniQure N.V. (ISIN IL0011559904) is trading around 44 dollars per share as of early September 2026, supported by a multi-billion-dollar market capitalization and renewed regulatory momentum in Huntington’s disease as of September 4, 2026.

FDA reversal boosts Huntington’s gene therapy prospects

According to an article on the Economic Times’ pharma portal dated September 4, 2026, uniQure has submitted a marketing application to the U.S. Food and Drug Administration for accelerated approval of its experimental Huntington’s disease gene therapy ifezuntirgene inilparvovec, also known as AMT-130, after the regulator reversed an earlier negative stance on the program.

The same report states that uniQure has requested priority review from the FDA, which would shorten the review period to about six months compared with a standard ten-month timeline and underlines the company’s push to bring the therapy to market faster for patients with this rare, inherited brain disorder.

Analysts see upside potential for QURE stock

In a separate analyst-focused article published on September 4, 2026, market data compiled by TipRanks and carried by The Globe and Mail highlights that uniQure shares recently closed at about 44.55 dollars, with a consensus analyst price target of approximately 66.67 dollars, implying an upside of roughly 46.5 percent from that reference level for QURE stock.

The same overview notes that multiple healthcare analysts currently assign a strong buy consensus rating to QURE, illustrating that, at least in the short term, professional investors see room for further appreciation if the Huntington’s program and broader gene therapy pipeline deliver on expectations.

Go deeper

Further background on QURE stock and fundamentals

Investors who want to track QURE stock more closely can find additional market data and regulatory news via the security overview and the company’s own investor communications.

All news on this ISIN Investor Relations

Huntington’s program as a commercial pillar

The Huntington’s disease gene therapy AMT-130 is positioned as a potential cornerstone product for uniQure if accelerated approval is granted, with three-year clinical data showing slowed disease progression compared with an external patient database, according to the Economic Times pharma report from September 4, 2026.

For QURE stock, the key question is whether the FDA will grant priority review and, ultimately, accelerated approval based on the existing dataset, which would open up a first commercial market opportunity in Huntington’s disease while the company continues to generate four-year follow-up data expected later in the current quarter of 2026.

QURE stock price and market metrics

Recent peer and market snapshots referenced in sector commentary show QURE stock trading in the mid-40 dollar range, with data points around 44.28 to 44.55 dollars per share as of September 4, 2026, placing the stock solidly above levels seen earlier in the year and reflecting rising expectations around the Huntington’s filing.

A same-day comparative overview that includes QURE among similar biotechnology names lists a market capitalization for uniQure of just over 3.2 billion dollars as of early September 2026 and notes a twelve-month share price performance of about plus 51.8 percent, underlining that QURE stock has significantly outperformed over the past year.