What's Going On With uniQure Stock Wednesday?

uniQure N.V. (NASDAQ:QURE) shares edged higher Wednesday after plunging in the previous session following an FDA setback related to the company’s investigational Huntington’s disease gene therapy.

The sharp decline came after the U.S. Food and Drug Administration advised against using Phase 1/2 study data as the primary evidence for the marketing application of AMT-130, raising uncertainty around the therapy’s regulatory path.

FDA Recommends New Study

The FDA on Monday strongly recommended that uniQure conduct a prospective, randomized, double-blind, sham surgery-controlled study to proceed with its application.

In November 2025, the company believed that the data from the Phase 1/2 studies might be adequate to support a Biologics License Application (BLA) submission, but the FDA’s recent stance has raised concerns about the viability of this approach.

uniQure plans to request a Type B meeting in the second quarter of 2026 for further discussions regarding the therapy’s development.

This setback comes as the company continues to advance its pipeline of proprietary gene therapies targeting severe diseases, including Huntington’s disease, refractory temporal lobe epilepsy, ALS, and Fabry disease.

QURE Faces Bearish Trend

The stock is currently trading 14.29% below its 20-day simple moving average (SMA) and 30.00% below its 100-day SMA, indicating a bearish trend. Shares have decreased significantly over the past 12 months and are currently positioned closer to their 52-week lows than highs.

The RSI is at 50.00, which is considered neutral territory. Meanwhile, MACD is at -0.10, below its signal line at 0.00, indicating bearish pressure on the stock. The combination of neutral RSI and bearish MACD suggests mixed momentum.

• Key Resistance: $10.00
• Key Support: $8.00

Analyst Consensus & Recent Actions: The stock carries a Buy Rating with an average price target of $39.69. Recent analyst moves include:

• Goldman Sachs: Neutral (Lowers Target to $9.00) (Mar. 3)
• Wells Fargo: Downgraded to Equal-Weight (Lowers Target to $15.00) (Mar. 3)
• Chardan Capital: Buy (Lowers Target to $16.00) (Mar. 3)

QURE Price Action: uniQure shares were up 1.50% at $9.16 at the time of publication on Wednesday. The stock is trading near its 52-week low of $7.76.

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