QURE Surges 8.9% Amid FDA Rejection Fallout: What's Fueling This Biotech Rally?

Summary
• uniQure (QURE) surges 8.9% to $23.84, rebounding from a 50% plunge in October after FDA rejected AMT-130 data
• Kessler Topaz law firm investigates potential securities violations, sparking short-term volatility
• Relative Strength (RS) rating upgraded to 93, signaling renewed technical strength
• Insider selling and regulatory uncertainty create mixed signals for long-term investors

uniQure’s stock is trading at its highest level since November 3, 2025, amid a volatile mix of regulatory scrutiny, technical upgrades, and insider activity. The FDA’s rejection of AMT-130 data triggered a 50% collapse in October, but recent options activity and a Relative Strength upgrade suggest short-term momentum. Investors must weigh the legal risks against technical indicators and sector dynamics.

FDA Rejection and Legal Scrutiny Drive Volatility
uniQure’s 8.9% intraday surge follows a dramatic 50% drop in October 2025 after the FDA rejected AMT-130 data for Huntington’s disease. The agency’s decision to no longer accept Phase I/II trial data as sufficient for a Biologics License Application (BLA) triggered a sell-off, but recent options buying and a Relative Strength upgrade indicate short-term optimism. Kessler Topaz’s investigation into potential securities violations adds regulatory uncertainty, yet the stock’s rebound suggests traders are betting on a legal resolution or a pivot in the FDA’s stance. The Relative Strength upgrade to 93 from 90 reflects improved technical momentum, though fundamentals remain challenged by negative profitability and insider selling.

Biotech Sector Mixed as AMGN Trails QURE’s Rally
The biotech sector remains fragmented, with Amgen (AMGN) up 0.29% despite QURE’s sharp rebound. AMGN’s modest gain highlights the sector’s cautious tone, as investors balance regulatory risks and R&D progress. While QURE’s rally is driven by technical upgrades and options activity, broader biotech stocks are constrained by macroeconomic concerns and earnings volatility. The sector’s divergence underscores the importance of company-specific catalysts over macro trends.

Options and ETFs to Capitalize on QURE’s Volatility
• RSI: 24.77 (oversold)
• MACD: -4.64 (below signal line -5.07)
• Bollinger Bands: 23.84 near upper band (31.51)
• 200D MA: 22.43 (below current price)

QURE’s technicals suggest a short-term bounce from oversold levels, with the 200-day MA acting as a key support. The RSI at 24.77 indicates potential for a rebound, while the MACD histogram’s positive shift hints at improving momentum. Traders should monitor the $25.71 intraday high and $22.82 low for directional clues. The biotech sector’s mixed performance, led by AMGN’s 0.29% gain, suggests sector-wide caution but leaves room for QURE’s legal-driven volatility.

Top Options:
• QURE20260116C25 (Call, $25 strike, Jan 16, 2026):
- IV: 107.41% (high volatility)
- Leverage Ratio: 9.64%
- Delta: 0.499 (moderate sensitivity)
- Theta: -0.060 (moderate time decay)
- Gamma: 0.0538 (strong price sensitivity)
- Turnover: 81,794 (high liquidity)
- Payoff (5% upside): $0.92 per share
- Why: High IV and gamma make this call ideal for a short-term rally, with liquidity ensuring smooth entry/exit.

• QURE20260116C26 (Call, $26 strike, Jan 16, 2026):
- IV: 130.42% (extreme volatility)
- Leverage Ratio: 8.65%
- Delta: 0.483 (moderate sensitivity)
- Theta: -0.0696 (high time decay)
- Gamma: 0.0442 (strong price sensitivity)
- Turnover: 4,245 (moderate liquidity)
- Payoff (5% upside): $1.92 per share
- Why: Aggressive bulls should target this strike for maximum leverage, though high IV and theta require quick execution.

Action: Aggressive bulls may consider QURE20260116C26 into a break above $25.71. Conservative traders should watch the $22.82 support level and AMGN’s performance for sector cues.

Backtest uniQure Stock Performance
The performance of uniQure (QURE) after a 9% intraday surge from 2022 to the present can be summarized as follows:1. Recent Surge: uniQure experienced a notable surge, with its shares up 7.08% during market hours after announcing that its partner CSL Behring received FDA approval for Hemgenix (etranacogene dezaparvovec) for treating hemophilia B patients over 18 years. 2. Clinical Development: The approval is a significant milestone, as it reflects the culmination of uniQure's research and clinical development efforts for Hemgenix. This achievement could have positively influenced investor sentiment, leading to the observed surge in stock price.3. Market Reaction: The market's response to this news suggests investor confidence in uniQure's capabilities and the potential for Hemgenix to make a meaningful impact in the treatment of hemophilia B.

QURE’s Legal and Technical Crossroads: What to Watch Now
uniQure’s 8.9% rebound reflects a mix of technical optimism and regulatory uncertainty. While the Relative Strength upgrade and options activity suggest short-term momentum, the FDA’s rejection of AMT-130 data and insider selling cast a long shadow. Traders should monitor the $25.71 intraday high for a potential breakout and the $22.82 low for a breakdown. AMGN’s 0.29% gain highlights the sector’s cautious tone, but QURE’s legal-driven volatility could create asymmetric opportunities. Watch for a regulatory update or a break above $25.71 to confirm the rally.