uniQure (QURE) Plunges 10% Amid FDA Regulatory Hurdles and Legal Scrutiny – What’s Next for Gene Therapy Giant?

Summary
• uniQure’s AMT-130 gene therapy faces FDA rejection of its BLA data package
• Stock plummets 9.95% intraday to $22.80, erasing $2.52 from previous close
• Kessler Topaz investigation into potential securities violations adds downward pressure

uniQure (QURE) is in freefall as a regulatory setback for its flagship Huntington’s disease gene therapy AMT-130 collides with a securities investigation. The stock has cratered 9.95% to $22.80, trading between $22.64 and $25.11 in a volatile session. With the FDA now demanding additional data for AMT-130’s accelerated approval pathway and a class-action lawsuit looming, investors are scrambling to reassess the company’s near-term viability.

FDA Rejects AMT-130 BLA Data, Sparking Sharp Sell-Off
The FDA’s recent notification that AMT-130’s Phase I/II data is insufficient for a Biologics License Application (BLA) has triggered a liquidity crisis in QURE. This follows a November 2025 announcement that the agency no longer accepts the external control data as primary evidence, forcing uniQure to rework its regulatory strategy. Compounding the issue, Kessler Topaz Meltzer & Check’s securities investigation into potential misrepresentations about AMT-130’s regulatory timeline has amplified investor anxiety. The stock’s 50% collapse from $67.69 to $34.29 in late 2025 has resurfaced as the market digests these risks.

Options Playbook: High-Leverage Puts and Calls for QURE’s Volatile Outlook
• MACD: -1.10 (bearish divergence from signal line -1.67)
• RSI: 57.68 (oversold territory but lacks momentum)
• Bollinger Bands: 26.60 (upper), 23.19 (middle), 19.78 (lower) – price near 19.78 support
• 200D MA: 23.28 (price below critical trendline)

QURE’s technicals suggest a breakdown scenario. The 200-day average at $23.28 acts as a pivot point; a close below $19.78 (lower Bollinger) could trigger a 57% drop to $9.76 (52W low). The RSI at 57.68 hints at oversold conditions but lacks bullish conviction. For options, focus on high-leverage puts and calls with short-term expiries (Jan 16, 2026) to capitalize on volatility.

Top Put: QURE20260116P22
• Strike: $22 | Delta: -0.3297 (moderate sensitivity)
• IV: 81.89% (elevated but not extreme)
• Leverage: 45.66% (high reward potential)
• Theta: -0.0121 (minimal time decay)
• Gamma: 0.1654 (responsive to price swings)
• Turnover: 898 (liquidity sufficient for entry/exit)
• Payoff (5% downside): $0.55 (max(0, 21.66 - 22))
• Why: High leverage and gamma make this put ideal for a 5% drop to $21.66, with IV at 81.89% reflecting market pessimism.

Top Call: QURE20260116C23
• Strike: $23 | Delta: 0.5026 (balanced directional exposure)
• IV: 105.36% (overpriced but reflects volatility)
• Leverage: 21.74% (moderate reward)
• Theta: -0.1995 (aggressive time decay)
• Gamma: 0.1417 (strong price sensitivity)
• Turnover: 20,847 (high liquidity)
• Payoff (5% downside): $0.00 (max(0, 21.66 - 23))
• Why: Despite a bearish scenario, this call offers a 21.74% leverage ratio and high gamma for a potential rebound above $23.50.

Action: Aggressive bears should prioritize QURE20260116P22 for a 5% downside play, while bulls may use QURE20260116C23 as a volatility hedge if the stock rallies above $23.50.

Backtest uniQure Stock Performance
The performance of QURE after a -10% intraday plunge from 2022 to now can be summarized as follows:1. Rebound Trend: Following the -10% drop, QURE experienced a 7.893% rebound over the last 20 days, indicating a trend towards recovery.2. Market Dynamics: The broader market dynamics, including index fund rebalancing and regulatory reforms, may have influenced QURE's performance. For instance, the S&P500 index's rebalancing mechanisms could have impacted QURE, especially if it is a constituent of the index.In conclusion, QURE has shown a positive rebound after its significant drop, and market dynamics may have played a role in its recent performance. However, specific investment strategies and market conditions would need to be considered for a comprehensive analysis.

Act Now: QURE Faces Regulatory and Legal Crossroads – Position for Volatility
uniQure’s near-term trajectory hinges on two catalysts: the FDA’s revised BLA requirements for AMT-130 and the outcome of the Kessler Topaz investigation. With the stock trading near its 52W low of $7.76 and technical indicators pointing to a breakdown, investors must prepare for a 57% drop to $9.76 or a rebound above $23.50. The sector leader, Amgen (AMGN), is down 0.29%, signaling a broader biotech malaise. Watch for a $19.78 support test or a $26.60 resistance break to determine the next move. Immediate action: Short-term traders should prioritize the QURE20260116P22 put for a 5% downside scenario, while long-term holders may wait for a post-FDA update bounce.